en
|
bg
Кариери
В 24-тата година от създаването си, Комак Медикал е най-голямата българска компания в сферата на клиничните изпитвания, със стабилен растеж и отлична репутация във фармацевтичната индустрия.
Кратък преглед:

С повече от 300 служители по целия свят, ние в Комак Медикал се стремим да създаваме удовлетворяваща работна среда, която подкрепя сътрудничеството, творчеството и професионалното изпълнение на поставените задачи.

Ние вярваме, че наетите от нас професионалисти са най-ценният актив на една компания. За това предлагаме на своите екипи възможности за изграждане на многостранна експертиза чрез работа върху различни проекти. В допълнение за стимулирането им, сме разработили план за социални придобивки и политики, който включва предоставяне на средства за социални нужди, стипендии за образование, допълнително здравно осигуряване и различни дейности по сплотяване на екипите.

 

В Комак Медикал наемаме едни от най-добрите и способните служители на всички експертни нива, които да се присъединят към изследователските ни усилия в целия свят.

Ако искате да станете част от нашият екип и да допринесете с опита си за развитието на компанията, или пък се интересувате от студентска практика в структурите на Комак Медикал, свържете се с нас на hr@comac-medical.com

Последни оферти за работа
Координатор Клиничен Център Познан

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 to work closely with CLINICAL SITE MANAGER, coordinate clinical research studies activities, streamline processes, administration and communication between 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

Координатор Клиничен Център София

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 to work closely with CLINICAL SITE MANAGER, coordinate clinical research studies activities, streamline processes, administration and communication between 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

Координатор Клиничен Център Краков

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 to work closely with CLINICAL SITE MANAGER, coordinate clinical research studies activities, streamline processes, administration and communication between 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.

Сътрудник Клинични Изпитвания София

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.

 

 

 

Сътрудник Клинични Изпитвания

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.

 

 

 

Сътрудник Клинични Изпитвания

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.

 

 

 

Сътрудник Клинични Изпитвания

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.

 

 

 

Мениджър Проекти

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.

Асистент Проекти

Great job opportunity for a CLINICAL REASRCH PROEJCT 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 professional to work closely with Project Leader, coordinate clinical research project activities, streamline processes and communication between parties involved.

 

What is expected to be done?

 

  • Assist Project Leader in monitoring and controlling the project milestones and timelines;
  • Support the supervision of project submission/ approval process to EC/ RA
  • Help in determination of project-specific oversight metrics, in agreement with the client;
  • Provide regular update on project status to the client and operational team, as required;
  • Assist in organization and supervision of project-specific training;
  • Ensure effective and proper communication between all parties involved in the project;
  • Handel organization of internal kick-off meeting as well as of kick-off meeting with the client;
  • Support quality group in preparation of project-specific audit;
  • Translate project-specific documents, when is required;
  • Assume additional responsibilities as requested by the Project Manager;

 

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;
  • Ability to keep deadlines, prioritize tasks and stay focused in a dynamic working environment;
  • Ability to pay attention to details, absorb and analyse specific project information;
  • 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.

Сърбия: Координатор Клиничен Център

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 Serbia for highly motivated and responsible candidates for the position of: Clinical Site Coordinator.

Knowledge, skills & abilities:

– Graduate or postgraduate degree

– At least 1 year’ experience in the field of 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.

– Proficiency in English.

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

– Ability to work under pressure and to keep tight deadlines.

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

 

Responsibilities:

 

Project responsibilities:

– Support all types of feasibility inquiries at the respective site(s);

– Conduct all types of feasibility inquiries at the respective site(s);

– Support the site team with regards to subject pre-selection and recruitment;

– Support the site team in subjects’ visits planning and preparation

– Prepare and organize source documentation;

– Complete Case Report Form;

– Collaborate and facilitate monitor on-site or remote visit;

– Maintain Investigator Site File;

– Participate in and if required 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;

– Perform additional study specific procedures, as delegated by the PI

– Support project team in the collection of site-specific documents

– Support the site team in audit/inspection preparation, as needed

 

General responsibilities:

– Represent Comac Medical in a professional manner.

– Perform other duties as assigned by Leadership.

– Follow strictly the applicable for the position company policies and procedures.

 

Country addsigned: Serbia

България: Сътрудник Клинични Изпитвания (I и II)

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: Clinical Research Associate (CRA I and II)

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

ОТПРАВИЗАПИТВАНЕ