Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, COMAC MEDICAL is a full-service providers of CRO and SMO with headquarter in Sofia, Bulgaria.
Clinical Research Associate
What is expected to be done?
- Conducts feasibility studies and site qualification visits;
- Develops and ensures a strong site relationship through all phases of the trial;
- Gains in-depth understanding of the study protocol and related procedures;
- Prepares study documentation eg 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;
- Ability to keep tight deadlines and work in a dynamic environment;
- Working knowledge of Word, Excel, and Power Point;
- Fluency in English language.
Why join Comac Medical?
- Great team of knowledgeable, high-achieving and experienced professionals;
- International and diverse working atmosphere;
- Challenging projects in a different therapeutical area as well as in early phases;
- Opportunity to enrich professional skills and progress in career development.
We kindly inform you that we will be contacting only selected candidates.
If you are interested, please send your application via the apply button.