Full-Time CRA
Job Description
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 proven professional to join our 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 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.
How to Apply
Send your CV to hr@comac-medical.com517 total views, 0 today