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Careers
Comac Medical is a Full Service CRO/SMO providing clinical research services across 30 countries. After more than 24 years on the field of clinical research we have a global presence. We take pride in our strong growth and solid reputation we’ve built within the drug development industry.
Overview

Our team‘s experience and expertise has distinguished Comac Medical which has become a leading CRO on the Balkan region. Our employees are remaining the most valuable asset. We recognize their essential contributions in building relationships with our clients and associates. We provide training and development to our staff needs’ to support them remain on top of their respective fields. We invest in employee professional development and personal growth, we reward their performance with compensation and benefits.

The Company Offers:
  • Work for successful and dynamic international company
  • Excellent internal training and career development opportunities in a perspective professional field
  • Stimulate and result orientated remuneration package

If you are interested apply on hr@comac-medical.com with your CV and cover letter describing why your experience and skills make you a good candidate for the position.

Recent Job Offers
Project leader

Great job opportunity for a CLINICAL REASRCH PROEJCT LEADER for one of the most reputable, full-service providers of CRO and SMO.

Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, COMAC MEDICAL is a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for pharmaceutical industry.

Currently we are looking for a proven professional to obtain the role with a flying start and deep dive into the daily tasks with confidence and knowledge.

 

What is expected to be done?

 

  • Monitor and manage project milestones and timelines as per the contract obligations;
  • Determine project-specific oversight metrics, as needed, in agreement with the client;
  • Perform risk assessment and propose mitigation strategy for the project;
  • Prepare, oversee, and review documents related to assigned clinical research project;
  • Provide regular updates of project status to the client and operational team;
  • Ensure effective and proper communication between all parties involved in the project;
  • Coordinate and conduct internal kick-off meeting as well as of kick-off meeting with the client;
  • Organize and supervise of project-specific training;
  • Oversee and control all logistic procedures related to the study and serve as a signal point of contact for the management and client;
  • Fully involved in resolving project issues, as well as take part in procedure improvement initiatives;
  • Supervise of project submission/approval process to EC/RA
  • Support quality group in preparation of project-specific audit as needed
  • Translation of project-specific documents, when necessary
  • Participate in marketing activities, client presentations, and proposal development

 

What is required for the role?

 

  • Graduate or postgraduate degree, preferably in the filed of Biology, Pharmacy, Chemistry or other relevant;
  • Minimum 3 years of experience in the leading role in a clinical research filed;
  • Excellent knowledge of clinical research process;
  • Excellent knowledge of current ICH/GCP guidelines and country-specific regulations;
  • Exceptional problem-solving, organizational, and leadership skills;
  • Outstanding communication skills – able to successfully convey massages across both dedicated team and external teams involved in the clinical research;
  • Ability to keep deadlines for multiple projects in a demanding working environment;
  • Ability to pay attention to details, absorb and analyse specific project data;
  • Working knowledge of Word, Excel, and Power Point;
  • Fluency in English language;

 

 

Why to join Comac Medical?

 

  • Great team of knowledgeable, high-achieving and experienced professionals;
  • International and diverse work atmosphere;
  • Challenging projects in a different therapeutical area as well as in early phases;
  • Opportunity to enrich professional skills and progress in career development;
  • Work from home policy
  • Competitive remuneration;
  • Additional health insurance and food vouchers;
  • Professional trainings;

 

Core strengths of Comac Medical

 

  • Proven track record for quality and delivery;
  • Established and trusted relationships with KOLs;
  • Motivated, capable and dedicated team;
  • Global full-service capabilities;

 

If you are interested, challenged and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English.

Only the shortlisted candidates will be contacted in a timely manner.

Clinical Research Associate Sofia

Great job opportunity for a CLINICAL RESEARCH ASSOCIATE for one of the most reputable, full-service providers of CRO and SMO.

Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, COMAC MEDICAL is a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for pharmaceutical industry.

Currently we are looking for a proven professional to obtain the role with a flying start and deep dive into the daily tasks with confidence and knowledge.

 

What is expected to be done:

 

  • Conducts feasibility studies and site qualification visits;
  • Develops and ensures strong site relationship through all phases of the trial;
  • Gains in-depth understanding of the study protocol and related procedures;
  • Prepares study documentation e.g. draft protocols, draft CRFs;
  • Collects, reviews, and monitors required regulatory documentation;
  • Communicates with Investigators and site staff on issues related to protocols;
  • Conducts recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance;
  • Performs remote and on-site monitoring & oversight activities;
  • Identifies, assesses and resolves site performance, quality or compliance problems
  • Escalates if necessary, by following CRA Escalation Pathway in collaboration with CTL/CMM/PL;
  • Assists in planning and execution of Investigator Meetings or other study related meetings;
  • Assume additional responsibilities as required by Project Manager;

 

 

What is required for the role?

 

  • Graduate or postgraduate degree, preferably in the filed of Biology, Pharmacy, Chemistry or other relevant;
  • At least 3 years of experience as a Clinical Research Associate/Clinical Monitor;
  • Excellent knowledge of clinical research process;
  • Good knowledge of all functional areas of clinical trial management;
  • Working knowledge of current ICH/GCP guidelines and applicable country-specific regulations;
  • Excellent organizational, communication (verbal and written)
  • Positive attitude and ability to interact with various levels of personnel
  • Good analytical and problem-solving skills;
  • Ability to travel for site monitoring and/or co-monitoring activities, attend investigator meetings or vendor visits/audits, as required (up to 30%)
  • Ability to keep tight deadlines and work in a dynamic environment;
  • Working knowledge of Word, Excel, and Power Point
  • Fluency in English language

 

 

Why to join Comac Medical?

 

  • Great team of knowledgeable, high-achieving and experienced professionals;
  • International and diverse work atmosphere;
  • Challenging projects in a different therapeutical area as well as in early phases;
  • Opportunity to enrich professional skills and progress in career development;
  • Competitive remuneration;
  • Professional trainings;

 

Core strengths of Comac Medical

 

  • Proven track record for quality and delivery;
  • Established and trusted relationships with KOLs;
  • Motivated, capable and dedicated team;
  • Global full-service capabilities;

 

If you are interested, challenged and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English.

Only the shortlisted candidates will be contacted in a timely manner.

 

 

 

Clinical Research Associate

Great job opportunity for a CLINICAL RESEARCH ASSOCIATE for one of the most reputable, full-service providers of CRO and SMO.

Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, COMAC MEDICAL is a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for pharmaceutical industry.

Currently we are looking for a proven professional to obtain the role with a flying start and deep dive into the daily tasks with confidence and knowledge.

 

What is expected to be done:

 

  • Conducts feasibility studies and site qualification visits;
  • Develops and ensures strong site relationship through all phases of the trial;
  • Gains in-depth understanding of the study protocol and related procedures;
  • Prepares study documentation e.g. draft protocols, draft CRFs;
  • Collects, reviews, and monitors required regulatory documentation;
  • Communicates with Investigators and site staff on issues related to protocols;
  • Conducts recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance;
  • Performs remote and on-site monitoring & oversight activities;
  • Identifies, assesses and resolves site performance, quality or compliance problems
  • Escalates if necessary, by following CRA Escalation Pathway in collaboration with CTL/CMM/PL;
  • Assists in planning and execution of Investigator Meetings or other study related meetings;
  • Assume additional responsibilities as required by Project Manager;

 

 

What is required for the role?

 

  • Graduate or postgraduate degree, preferably in the filed of Biology, Pharmacy, Chemistry or other relevant;
  • At least 3 years of experience as a Clinical Research Associate/Clinical Monitor;
  • Excellent knowledge of clinical research process;
  • Good knowledge of all functional areas of clinical trial management;
  • Working knowledge of current ICH/GCP guidelines and applicable country-specific regulations;
  • Excellent organizational, communication (verbal and written)
  • Positive attitude and ability to interact with various levels of personnel
  • Good analytical and problem-solving skills;
  • Ability to travel for site monitoring and/or co-monitoring activities, attend investigator meetings or vendor visits/audits, as required (up to 30%)
  • Ability to keep tight deadlines and work in a dynamic environment;
  • Working knowledge of Word, Excel, and Power Point
  • Fluency in English language

 

 

Why to join Comac Medical?

 

  • Great team of knowledgeable, high-achieving and experienced professionals;
  • International and diverse work atmosphere;
  • Challenging projects in a different therapeutical area as well as in early phases;
  • Opportunity to enrich professional skills and progress in career development;
  • Competitive remuneration;
  • Professional trainings;

 

Core strengths of Comac Medical

 

  • Proven track record for quality and delivery;
  • Established and trusted relationships with KOLs;
  • Motivated, capable and dedicated team;
  • Global full-service capabilities;

 

If you are interested, challenged and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English.

Only the shortlisted candidates will be contacted in a timely manner.

 

 

 

Research Assistant - Romania

Great job opportunity for a CLINICAL RESARCH ASSISTANT for one of the most reputable, full-service providers of CRO and SMO, COMAC MEDICAL, with headquarter in Sofia, Bulgaria.

Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, we are a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for pharmaceutical industry.

Currently we are looking for a proven professional to join our Polish team.

 

What is expected to be done:

  • Assist in the investigator site selection and qualification, as directed;
  • Updates and maintains tracking logs, as required
  • Maintains project specific company folders
  • Collects and file initial and ongoing study documentation for submission/notification to Competent Authority;
  • Assists CRA with ITMF (ISF) preparation
  • Assists CTL/CRA with site correspondence
  • Scans and uploads documents to the eTMF system if applicable, ensure documents are of good quality prior to upload
  • Prepares and sends documents for paper TMF
  • Assists in the planning and execution of Investigator Meetings
  • Assists in the planning and execution of monitoring activities as requested by CRA/CTL
  • Performs project-specific documents translations, if required;
  • Assists, as directed, in file audits

 

What is required for the role?

  • Graduate or postgraduate degree, preferably in the filed of Biology, Pharmacy, Chemistry
  • Working knowledge of current ICH/GCP guidelines and applicable country-specific regulations
  • Positive attitude and ability to interact with all levels of staff
  • Proficiency in English
  • Ability to work under pressure and to keep tight deadlines
  • Working knowledge of Word, Excel, and Power Point.

 Why to join Comac Medical?

  • Great team of knowledgeable, high-achieving and experienced professionals;
  • International and diverse work atmosphere;
  • Challenging projects in a different therapeutic area as well as in early phases;
  • Opportunity to enrich professional skills and progress in career development;
  • Competitive remuneration;
  • Professional trainings;

Core strengths of Comac Medical

  • Proven track record for quality and delivery;
  • Established and trusted relationships with KOLs;
  • Motivated, capable and dedicated team;
  • Global full-service capabilities;

If you are interested, challenged and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English.

Only the shortlisted candidates will be contacted in a timely manner.

 

 

Research Assistant - Poland

Great job opportunity for a CLINICAL RESARCH ASSISTANT for one of the most reputable, full-service providers of CRO and SMO, COMAC MEDICAL, with headquarter in Sofia, Bulgaria.

Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, we are a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for pharmaceutical industry.

Currently we are looking for a proven professional to join our Polish team.

 

What is expected to be done:

  • Assist in the investigator site selection and qualification, as directed;
  • Updates and maintains tracking logs, as required
  • Maintains project specific company folders
  • Collects and file initial and ongoing study documentation for submission/notification to Competent Authority;
  • Assists CRA with ITMF (ISF) preparation
  • Assists CTL/CRA with site correspondence
  • Scans and uploads documents to the eTMF system if applicable, ensure documents are of good quality prior to upload
  • Prepares and sends documents for paper TMF
  • Assists in the planning and execution of Investigator Meetings
  • Assists in the planning and execution of monitoring activities as requested by CRA/CTL
  • Performs project-specific documents translations, if required;
  • Assists, as directed, in file audits

 

What is required for the role?

  • Graduate or postgraduate degree, preferably in the filed of Biology, Pharmacy, Chemistry
  • Working knowledge of current ICH/GCP guidelines and applicable country-specific regulations
  • Positive attitude and ability to interact with all levels of staff
  • Proficiency in English
  • Ability to work under pressure and to keep tight deadlines
  • Working knowledge of Word, Excel, and Power Point.

Why to join Comac Medical?

  • Great team of knowledgeable, high-achieving and experienced professionals;
  • International and diverse work atmosphere;
  • Challenging projects in a different therapeutic area as well as in early phases;
  • Opportunity to enrich professional skills and progress in career development;
  • Competitive remuneration;
  • Professional trainings;

Core strengths of Comac Medical

  • Proven track record for quality and delivery;
  • Established and trusted relationships with KOLs;
  • Motivated, capable and dedicated team;
  • Global full-service capabilities;

If you are interested, challenged and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English.

Only the shortlisted candidates will be contacted in a timely manner.

 

Data Manager - Bulgaria

Great job opportunity for a Data Manager for one of the most reputable, full-service providers of CRO and SMO.

Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, COMAC MEDICAL is a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for pharmaceutical industry.

Currently, we are looking for an inspiring Leader to join our Data Management team of highly achieved and dedicate professionals.

 What is expected to be done?

  • Act as Lead Data Manager, coordinate data management team to successful completion of clinical trial projects within given timelines;
  • Interact with clients and project manager as main contact person
  • Prepare and review paper CRF, annotated CRF, EDC specification, Data Validation Specification, Data Management Plan
  • Set-up and validate the study-specific clinical database;
  • Develop CRF Completion Guidelines;
  • Supervise double data entry process;
  • Monitor coding and medical review processes related to clinical database
  • Prepare Data Transfer Agreements;
  • Perform QC of the database in case of double data entry;
  • Track and clean the data in the clinical database;
  • Prepare of study specific data management documents for trial master file;
  • Assist Quality Group in preparation of data management SOPs;
  • Support Quality Group in preparation of audit on the Data Management activities;

 

What is required for the role?

  • University degree in Mathematics, Computer Science or relevant fields;
  • At least 2 years of experience in Data Management in the clinical trial settings;
  • Thorough knowledge of current ICH/GCP guidelines and applicable regulations;
  • Strong working knowledge of SDTM, CDISC controlled terminology;
  • Experience with SAS and/or SQL;
  • Excellent analytical capabilities, inclination to non-standard problem solving;
  • Excellent organizational, communication and interpersonal skills;
  • Positive attitude and ability to interact with all levels of staff;
  • Proficiency in English;
  • Ability to keep and work with tight deadlines;

 

Why to join Comac Medical?

  • Great team of knowledgeable, high-achieving, and experienced professionals;
  • International and diverse work atmosphere;
  • Challenging projects in a different therapeutical area as well as in early phases;
  • Opportunity to enrich professional skills and progress in career development;
  • Work from home policy
  • Competitive salary and social benefits;

 

Core strengths of Comac Medical:

  • Dedicated state-of-art Phase I Unit;
  • Proven track record for quality and delivery;
  • Established and trusted relationships with KOLs;
  • Motivated, capable and dedicated team;
  • Global full-service capabilities;

 

 Do not ignore this opportunity! Check it out!

I will be glad to speak to you and give you more details about the company, projects, values, people etc

 

 

Regulatory Affairs Specialist - Bulgaria

Great job opportunity for a REGULATORY AFFAIRS SPECIALIST for one of the most reputable, full-service providers of CRO and SMO

Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, COMAC MEDICAL is a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for pharmaceutical industry.

 

 What is expected to be done?

  • Establish study regulatory strategy with client and project team;
  • Discuss and agree the submission timelines with the Project Leader and the client;
  • Perform quality check of clinical trial documentation prior to EC and RA submission as per the local requirements and SOP in close collaboration with the study team;
  • Assist in resolving issues related to submission process and requirements;
  • Initiate and participate in internal discussions for regulatory requirements and issues;
  • Reviews project documents for regulatory completeness, consistency and accuracy, interacts with project team members to assure completeness, as necessary;
  • Support Global Regulatory Affairs Manager in determination of regulatory strategy/expectations and parameters for submissions and all necessary authorizations, as requested;
  • Support Global Regulatory Affairs Manager in implementation of the regulatory changes;
  • Support the Global Regulatory Affairs Manager in developing a strategy for ensuring regulatory intelligence, as needed;

 What is required for the role?

  • Graduate or postgraduate degree;
  • At least 1-year experience in regulatory activities with regards to the clinical research;
  • Working knowledge of current ICH/GCP guidelines, applicable regulations (including country specific ones), and current industry practices;
  • Excellent organizational, communication (verbal and written) and interpersonal skills;
  • Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings;
  • Positive attitude and ability to interact with all levels of staff;
  • Ability to work under pressure and to keep tight deadlines;
  • Proficiency in English;
  • Working knowledge of Word, Excel, and Power Point;

 

Why to join Comac Medical?

  • Great team of knowledgeable, high-achieving and experienced professionals;
  • International and diverse work atmosphere;
  • Challenging projects in a different therapeutical area as well as in early phases;
  • Opportunity to enrich professional skills and progress in career development;
  • Competitive remuneration;
  • Professional trainings;

 

Core strengths of Comac Medical

  • Proven track record for quality and delivery;
  • Established and trusted relationships with KOLs;
  • Motivated, capable and dedicated team;
  • Global full-service capabilities;

If you are interested, challenged and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English.

Only the shortlisted candidates will be contacted in a timely manner.

 

Clinical Trial Lead - Bulgaria

Great job opportunity for a CLINICAL TRAIL LEAD for one of the most reputable, full-service providers of CRO and SMO.

Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, COMAC MEDICAL is a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for pharmaceutical industry.

Currently we are looking for a professional inspired by the opportunity to manage and oversee clinical trial projects, ensure quality, collaborate actively with the clinical project managers and sponsors, lead the clinical monitoring team.

 CLINICAL TRIAL LEAD

 

What is expected to be done?

Project Related responsibilities:

  • Monitor activities oversight of assigned projects and as primary liaison for all clinical monitoring issues;
  • Collaborate with Clinical Monitor Manager to ensure adequate CRA/RA resources are assigned to the project;
  • Lead and coordinate the CRA team, ensure appropriate CRA visit scheduling per protocol and monitoring;
  • Provide oversight of the entire site supervision process for the life cycle of the trial sites;
  • Collaborate with the CRA to develop Corrective Action Plan (CAP) relateed to non-compliance at site if necessary.
  • Assist in GCP audit preparation and file reviews for different sites, internal teams and Clinical Research Associates;
  • Assist PM for identification of potential risks to site performance and monitoring activities;
  • Attend the project kick-off meeting, launch investigators meetings and make presentations;
  • Conduct and assist with project specific training, oversight and mentoring of CRAs and RAs
  • Communicate with Data Manager, Pharmacovigilance Manager and Medical Monitor on resolving project-related issues and obtaining follow-up information;
  • Review ERP System information to provide oversight and ensure timely entry of all operational information;
  • Provide regular status reports to the PM, Management and the Sponsor on site initiation, enrolment oversight, monitoring visits and trip report completion;
  • Provide input into and/or develop study related materials such as Clinical Monitoring Plans, Data Management Plans, eCRF forms and completion guidelines;
  • Ensure that compliance with the applicable SOPs, quality documents and guidelines, protocol and amendments is maintained by the CRAs/RAs during the project.

Human resource related Responsibilities:

  • Contribute to CRA team knowledge by acting as Subject Matter Expert
  • Conduct field training and assessment of CRAs
  • Provide co-monitoring with assigned CRAs
  • Assist in completion of monthly KPI

 What is required for the role?

  • Graduate or postgraduate degree;
  • At least 6 years as a Clinical Research Associate/Clinical Monitor;
  • At least 1 years’ experience providing work direction and leadership to people and teams including employees’ development, performance management and conflict resolution
  • Thorough knowledge of clinical research process, including working knowledge of all functional areas of clinical trial management.
  • Working knowledge of current ICH/GCP guidelines and applicable country-specific regulations.
  • Excellent organizational, communication (verbal and written) and interpersonal skills.
  • Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings.
  • Positive attitude and ability to interact with all levels of staff.
  • Ability to work under pressure and to keep tight deadlines.
  • Proficiency in English.
  • Working knowledge of Word, Excel, and Power Point.

Why to join Comac Medical?

  • Great team of knowledgeable, high-achieving and experienced professionals;
  • International and diverse work atmosphere;
  • Challenging projects in a different therapeutical area as well as in early phases;
  • Opportunity to enrich professional skills and progress in career development;
  • Competitive remuneration;
  • Professional trainings;

Core strengths of Comac Medical

  • Proven track record for quality and delivery;
  • Established and trusted relationships with KOLs;
  • Motivated, capable and dedicated team;
  • Global full-service capabilities;

If you are interested, challenged and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English.

Only the shortlisted candidates will be contacted in a timely manner.

Clinical Research Associate - Romania

Great job opportunity for a CLINICAL RESEARCH ASSOCIATE for one of the most reputable, full-service providers of CRO and SMO, COMAC MEDICAL,  with headquarter in Sofia, Bulgaria.

Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, we are a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for pharmaceutical industry.

 

Currently we are looking for a professional to join our Polish Team

What is expected to be done:

  • Conducts feasibility studies and site qualification visits;
  • Develops and ensures strong site relationship through all phases of the trial;
  • Gains in-depth understanding of the study protocol and related procedures;
  • Prepares study documentation e.g. draft protocols, draft CRFs;
  • Collects, reviews, and monitors required regulatory documentation;
  • Communicates with Investigators and site staff on issues related to protocols;
  • Conducts recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance;
  • Performs remote and on-site monitoring & oversight activities;
  • Identifies, assesses and resolves site performance, quality or compliance problems
  • Escalates if necessary, by following CRA Escalation Pathway in collaboration with CTL/CMM/PL;
  • Assists in planning and execution of Investigator Meetings or other study related meetings;
  • Assume additional responsibilities as required by Project Manager;

What is required for the role?

  • Graduate or postgraduate degree, preferably in the filed of Biology, Pharmacy, Chemistry or other relevant;
  • At least 3 years of experience as a Clinical Research Associate/Clinical Monitor;
  • Excellent knowledge of clinical research process;
  • Good knowledge of all functional areas of clinical trial management;
  • Working knowledge of current ICH/GCP guidelines and applicable country-specific regulations;
  • Excellent organizational, communication (verbal and written)
  • Positive attitude and ability to interact with various levels of personnel
  • Good analytical and problem-solving skills;
  • Ability to travel for site monitoring and/or co-monitoring activities, attend investigator meetings or vendor visits/audits, as required (up to 30%)
  • Ability to keep tight deadlines and work in a dynamic environment;
  • Working knowledge of Word, Excel, and Power Point
  • Fluency in English language

Why to join Comac Medical?

  • Great team of knowledgeable, high-achieving and experienced professionals;
  • International and diverse work atmosphere;
  • Challenging projects in a different therapeutic area as well as in early phases;
  • Opportunity to enrich professional skills and progress in career development;
  • Competitive remuneration;
  • Professional trainings;

Core strengths of Comac Medical

  • Proven track record for quality and delivery;
  • Established and trusted relationships with KOLs;
  • Motivated, capable and dedicated team;
  • Global full-service capabilities;

If you are interested, challenged and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English.

Only the shortlisted candidates will be contacted in a timely manner.

 

Site Coordinator - Romania

Great job opportunity for a SITE COORDINATOR for one of the most reputable, full-service providers of CRO and SMO

Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, COMAC MEDICAL is a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for pharmaceutical industry.

Currently we are looking for a professional based in Krakow to coordinate clinical research studies activities, streamline processes, administration and communication between sites and teams involved in.

 

What is expected to be done?

  • Support all types of feasibility inquiries at the respective site;
  • Asist the site team with regards to subject pre-selection and recruitment;
  • Help the site team in subjects’ visits planning and preparation;
  • Organize various source of documentation;
  • Complete Case Report Form and maintain Investigator Site File;
  • Participate and coordinate any trainings and meetings (incl. Investigator Meetings) related to a specific study;
  • Collaborate with the site team for any adverse events and safety information reporting and escalation;
  • Organize and coordinate logistic of study medication, other study supplies and biological samples;
  • Ensure timely site equipment maintenance and calibration;
  • Handle subject expenses reimbursement;
  • Support project team in the collection of site-specific documents;
  • Support the site team in audit/inspection preparation, as needed

 What is required for the role?

 Graduate or postgraduate degree, preferably in the filed of Biology, Pharmacy, Chemistry or other relevant;

  • One year of experience in the leading role in a clinical research filed;
  • Very good knowledge of clinical research process;
  • Sound knowledge of current ICH/GCP guidelines and country-specific regulations;
  • Particularly good organizational and coordination skills;
  • Excellent communication skills both written and spoken;
  • Working knowledge of Word, Excel, and Power Point;
  • Fluency in English language;

Why to join Comac Medical?

  • Great team of knowledgeable, high-achieving and experienced professionals;
  • International and diverse work atmosphere;
  • Challenging projects in a different therapeutical area as well as in early phases;
  • Opportunity to enrich professional skills and progress in career development;
  • Competitive remuneration;
  • Professional trainings;

Core strengths of Comac Medical

  • Proven track record for quality and delivery;
  • Established and trusted relationships with KOLs;
  • Motivated, capable and dedicated team;
  • Global full-service capabilities;

If you are interested, challenged and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English.

Only the shortlisted candidates will be contacted in a timely manner.

 

 

Bulgaria: Senior Clinical Research Associate (III)

COMAC MEDICAL is a Full-service CRO/SMO providing a broad network of clinical research sites in the best healthcare institutions across Central and Eastern Europe. Due to our successful development we are looking for our new projects in Bulgaria highly motivated and responsible candidates for the position of: Senior Clinical Research Associate (III)

The person:

– Graduate or postgraduate degree

– At least 4 years as a Clinical Research Associate/Clinical Monitor

– Thorough knowledge of clinical research process, including working knowledge of all functional areas of clinical trial management.

– Working knowledge of current ICH/GCP guidelines and applicable country-specific regulations.

– Excellent organizational, communication (verbal and written) and interpersonal skills.

– Positive attitude and ability to interact with all levels of staff.

– Proficiency in English

– Ability to work under pressure and to keep tight deadlines

– Working knowledge of Word, Excel, and Power Point.

 

The activities:

– Conducts feasibility studies, as requested

– Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.

– Gains an in-depth understanding of the study protocol and related procedures

– Conducts site qualification visits

– Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out

– Customizes patient information sheets and consent forms, as required

– Participate, if requested, in the preparation of and review of study documentation e.g. draft protocols, draft CRFs;

– Participates in contracting process, if required

– Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

– Performs remote and on-site monitoring & oversight activities

– Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CTL/CMM/PL

– Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines

– Assists in audit preparations;

– Updates and maintains tracking logs, if required

– Performs project-specific documents translations, if required;

– Assists in the planning and execution of Investigator Meetings or other study related meetings;

– Assume additional responsibilities as directed by Project Manager.

– Human resource management

–       Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME)

 

The Company Offer:

– Work for successful international company, excellent career development opportunity in a perspective professional field;
– Competitive remuneration package;
– Additional benefits related to work performance;
– Work in a team of motivated and qualified professionals;
– Оpportunity for development and learning in the work process.

The Assigned Country: Bulgaria

Clinical Research Associate - Poland

Great job opportunity for a CLINICAL RESEARCH ASSOCIATE for one of the most reputable, full-service providers of CRO and SMO, COMAC MEDICAL,  with headquarter in Sofia, Bulgaria.

Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, we are a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for pharmaceutical industry.

Currently we are looking for a professional to join our Polish Team

 

What is expected to be done:

  • Conducts feasibility studies and site qualification visits;
  • Develops and ensures strong site relationship through all phases of the trial;
  • Gains in-depth understanding of the study protocol and related procedures;
  • Prepares study documentation e.g. draft protocols, draft CRFs;
  • Collects, reviews, and monitors required regulatory documentation;
  • Communicates with Investigators and site staff on issues related to protocols;
  • Conducts recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance;
  • Performs remote and on-site monitoring & oversight activities;
  • Identifies, assesses and resolves site performance, quality or compliance problems
  • Escalates if necessary, by following CRA Escalation Pathway in collaboration with CTL/CMM/PL;
  • Assists in planning and execution of Investigator Meetings or other study related meetings;
  • Assume additional responsibilities as required by Project Manager;

What is required for the role?

  • Graduate or postgraduate degree, preferably in the filed of Biology, Pharmacy, Chemistry or other relevant;
  • At least 3 years of experience as a Clinical Research Associate/Clinical Monitor;
  • Excellent knowledge of clinical research process;
  • Good knowledge of all functional areas of clinical trial management;
  • Working knowledge of current ICH/GCP guidelines and applicable country-specific regulations;
  • Excellent organizational, communication (verbal and written)
  • Positive attitude and ability to interact with various levels of personnel
  • Good analytical and problem-solving skills;
  • Ability to travel for site monitoring and/or co-monitoring activities, attend investigator meetings or vendor visits/audits, as required (up to 30%)
  • Ability to keep tight deadlines and work in a dynamic environment;
  • Working knowledge of Word, Excel, and Power Point
  • Fluency in English language

 

Why to join Comac Medical?

  • Great team of knowledgeable, high-achieving and experienced professionals;
  • International and diverse work atmosphere;
  • Challenging projects in a different therapeutic area as well as in early phases;
  • Opportunity to enrich professional skills and progress in career development;
  • Competitive remuneration;
  • Professional trainings;

Core strengths of Comac Medical

  • Proven track record for quality and delivery;
  • Established and trusted relationships with KOLs;
  • Motivated, capable and dedicated team;
  • Global full-service capabilities;

If you are interested, challenged and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English.

Only the shortlisted candidates will be contacted in a timely manner.

 

SUBMIT RFP