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Careers
Comac Medical is a Full Service CRO/SMO providing clinical research services across 30 countries. After more than 23 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
Hungary: Clinical Research Associate

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 Hungary highly motivated and responsible candidates for the position of: Clinical Research Associate

Duties and activities:
– 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
– Participates & provides inputs on site selection activities as required
– Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out
– Customize 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 Lead CRA/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.

The Person:
– Graduate or postgraduate degree
– At least 1 year and half 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.
– 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.

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;
– Opportunity for development and learning in the work process.

The Assigned Country: Hungary

Slovenia: Clinical Research Associate

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 Slovenia highly motivated and responsible candidates for the position of: Clinical Research Associate

Duties and activities:
– 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
– Participates & provides inputs on site selection activities as required
– Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out
– Customize 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 Lead CRA/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.

The Person:
– Graduate or postgraduate degree
– At least 1 year and half 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.
– 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.

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;
– Opportunity for development and learning in the work process.

The Assigned Country: Slovenia

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

Bulgaria: Clinical Research Associate (I and 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:

 

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

Bulgaria: Biostatistician

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 Early Phase Clinical Development Division in Sofia highly motivated and responsible candidates for the position of:

Biostatistician

The Profile:

– Act as Lead Biostatistician in order to coordinate project team to successful completion of a project within given time lines
– Interact with clients and project management team as contact person with regard to statistical issues, if necessary
– Provide statistical supervision to the project members, as needed
– Design and execute statistical plans independently for all phases of clinical studies, assuming a leadership role in creating strategy for study design and analyses.
– Review clinical study protocols and Case Report Forms (CRFs) for proposed studies with respect to statistical methodology.
– Sample size calculation and justification
– Preparation of Randomization schedules, as needed
– Participate in the review and assessment of protocol deviations to the extent that they affect statistical analyses
– Produce statistical reports that may be incorporated into internal clinical reports or regulatory submissions
– Development or check of SAS programming codes for the purpose of statistical analysis (including analysis database, statistical analysis and Tables/Listing/Figures if necessary)
– Development of standard SAS macros for general purpose
– Preparing of study specific statistical documents for trial master file
– Support Quality Group in preparation of statistical SOPs as needed
– Support Quality Group in preparation of study-specific audit
– Preparation ADaM datasets and define. xml, as needed

The Person:
– University degree in Biostatistics, Statistics, Applied Mathematics or relevant field
– At least 3 years’ experience in Biostatistics in performing statistical analyses in a regulated environment, including GCP or other relevant area is required.
– Experience with writing/reviewing statistical analysis plans, working on study protocol, study design and ad hoc analysis
– Thorough knowledge of current ICH/GCP guidelines and applicable country-specific regulations
– Proficiency in SAS (knowledge on additional statistical package is advantage)
– Thorough understanding of descriptive statistics, power/sample size analysis, hypothesis testing, parametric, non-parametric, and multivariate statistical tests is required.
– Demonstrated technical experience in preparing statistical deliverables on time is required
– Excellent analytical capabilities, inclination to non-standard problem solving
– 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 Company Offers:
– Competitive and result orientated remuneration package;
– Work for successful international company;
– Excellent training and career development opportunities;
– Friendly working environment.

The Assigned Country: Bulgaria.

Bulgaria: Medical Writer

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 Montana for highly motivated and responsible candidates for the position of: Medical Writer.

Duties and activities:
– Creation or review of Clinical Study Protocols (for early and late phase clinical trials, non-interventional studies, PASS etc.);
– Participation in creation of Clinical Development Program, as directed;
– Creation or review of Participant information and Informed Consent Form;
– Preparation of clinical sections of New Drug Applications (NDAs);
– Preparation or review of Investigator Brochure;
– Preparation or review of Integrated Clinical Study Report (ICSR);
– Preparation or review of Manuscripts and posters;
– Preparation or review of other medical/technical documents, as directed.

The Person:
– Graduate or postgraduate degree in Medical Sciences, Life Sciences, Biostatistics or another relevant field;
– At least 2 years’ experience in clinical research;
– Knowledge of regulations relevant to medical writing;
– Good understanding of common statistical methods used in clinical trials or pharmaceutical work and/or interpretation of their results;
– Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner;
– 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.

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

Bulgaria: Clinical Research Associate

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.

Duties and activities:
– 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
– Participates & provides inputs on site selection activities as required
– Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out
– Customize 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 Lead CRA/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.

The Person:
– Graduate or postgraduate degree
– At least 1 year and half 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.
– 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.

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;
– Opportunity for development and learning in the work process.

The Assigned Country: Bulgaria

Poland: Clinical Research Associate

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 Poland highly motivated and responsible candidates for the position of: Clinical Research Associate

Duties and activities:
– 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
– Participates & provides inputs on site selection activities as required
– Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out
– Customize 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 Lead CRA/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.

The Person:
– Graduate or postgraduate degree
– At least 1 year and half 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.
– 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.

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;
– Opportunity for development and learning in the work process.

The Assigned Country: Poland

Turkey: Clinical Site Coordinator

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

The Profile:
− Supporting Principal Investigator in equipment and staff needs planning;
− Collection and transfer of site-related documents for initial submission package and ongoing submission package;
− Regular updates of essential documents;
− Assisting in preparation of any study related documents;
− Assisting in CRF completion, when applicable;
− Logistic support related to transfer of information and materials;
− Collaborate with the site team concerning patients pre-screening and recruitment
− Activities related to drug storage, total reconciliation and documents completion;
− Collaborate and facilitate monitor on-site or remote visit;
− Report the trial progress by writing reports and collecting trial-specific data, keeping correspondence, participating in project meetings and teleconferences;
− Financial accountability for patients’ travel expenses;
− First point of contact with CRA/ CRO.

The Person:
− University degree in Medical or Life Sciences is preferable;
− Experience in Clinical Trials activities is preferable;
− Excellent command of English – both written and spoken;
− Excellent computer literacy;
− Active driver;
− Very good attention to details, excellent analytical capabilities;
− Responsible, pro-active, well-organized and committed person, team player;
− Ability to work under pressure and to keep tight deadlines.

The Company Offer:
− Job-specific training;
− Work for a successful international company, excellent career development opportunity in a perspective professional field;
− Competitive and result orientated remuneration;
− Additional benefits related to work performance.

The Assigned Country: Turkey

Bulgaria: Pharmacovigilance Specialist

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 highly motivated and responsible candidates for the position of:

Pharmacovigilance Specialist (PV Specialist)

The Profile:
– Operate as an EU QPPV (Qualified Person Responsible for Pharmacovigilance) for MAHs (Marketing Authorization Holders) and Local QPPV
– Ensure the uniform and timely processing of expedited reports from clinical trials or post-marketing in accordance with SOPs and worldwide regulatory authority expectations;
– Ensure compliance with health authority regulations in all aspects of PV case processing and reporting;
– Collect and maintain database with PV regulations and requirements for Comac Medical countries of operation;
– Ensure valid SAE cases are completely and accurately data-entered into pharmacovigilance/ safety database;
– Oversee receipt, confirmation, and processing of clinical study serious adverse events (SAE) reports from multiple countries;
– Ensure all safety reports are evaluated, assessed and completed;
– Write or contribute to preparation of safety documentation for clinical trials (DSURs, Safety Management Plan, safety data line-listings etc.) and PV documentation for post-marketing (PSUR, PBRERs, Risk Management Plans etc.);
– Contribute to the development or maintenance of a Pharmacovigilance System Master Files for clients;
– Assist with pharmacovigilance processes, preparation of SOPs, product safety reviews and literature reviews, if required;
– GVP module I (I.C.1.3. Role of the qualified person responsible for pharmacovigilance in the EU;
– VOLUME 9A – Guidelines on Pharmacovigilance for Medicinal Products for Human Use (1.2.1 The Role and Responsibilities of the Qualified Person Responsible for Pharmacovigilance;
– Monitor and assess Drug Safety and benefit-risk profile from EU perspective for different therapeutic areas;
– Maintain project-specific safety database/ adverse event tracking systems;
– 24h/7day contact for reporting safety data;
– Execute routine quality review of SAE reports and other safety reports for other members;
– Triage events for expectedness and reportability along with the CRO;
– Liaise with clinical operations, regulatory affairs and data management regarding safety data collection and data reconciliation;
– 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;

The Person:
− University degree in Medicine or Life Science;
− 4 years experience on a similar position;
− Regulatory experience will be considered as advantage;
− Responsible, pro-active, well-organized, team player;
− Good command of spoken and written English;
− Very good computer literacy;
− Willingness to expand his/ her professional expertise.
− Very good attention to details, excellent analytical capabilities.
The Company Offer:
− Job-specific training;
− Work for successful international company, excellent career development opportunity in a perspective professional field;
− Very competitive remuneration package;
− Additional benefits related to work performance.

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;
– Opportunity for development and learning in the work process

The Assigned Country: Bulgaria

If you are interested in such an opportunity please send your CV and a cover letter in English describing why your experience and skills make you a good candidate for this position.

Spain: Clinical Research Associate 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 Spain highly motivated and responsible candidates for the position of:

Clinical Research Associate II

Duties and activities:
– 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
– Participates & provides inputs on site selection activities as required
– Collects, reviews, and monitors required regulatory documentation for study start-up, study mainte-nance and study close-out
– Customize 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 perfor-mance.
– 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 Lead CRA/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.

The Person:
– Graduate or postgraduate degree
– At least 2 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.
– 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.

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: Spain

SUBMIT RFP