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.