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 provide innovative and non-conventional solutions of high quality for the pharmaceutical industry.
We are looking for a professional to join our North Macedonian Team in Skopje.
What is expected to be done?
- Conducts feasibility studies and site qualification visits;
- Develops and ensures strong site relationships through all phases of the trial;
- Gains an in-depth understanding of the study protocol and related procedures;
- Prepares study documentation e.g. draft protocols, and 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 in the field of Pharmacy, Dentistry or Medicine;
- 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 join Comac Medical?
- Great team of knowledgeable, high-achieving and experienced professionals;
- International and diverse work atmosphere;
- Challenging projects in a different therapeutic area as well as in early phases;
- Opportunity to enrich professional skills and progress in career development;
- Competitive remuneration;
- Professional training;
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 at [најави се за да го видиш е-маилот]
Only the shortlisted candidates will be contacted in a timely manner.