CLINICAL TRIALS ASSOCIATE
MB Quest has openings for Clinical Trials Associates. These are in-house, full-time positions based in our office in Kiev.
To deliver organizational and administrative support to MBQ project teams in the conduct of clinical studies.
Key Responsibilities & Critical Objectives
- Assist Clinical Operations Manager, Clinical Research Associates and Project Managers with the day-to-day management of clinical studies. Manage all aspects of trial administration for assigned studies.
- Perform feasibility studies, under direction, utilizing phone scripts, questionnaires and other tools in evaluation of investigative sties.
- Perform critical document collection, review and maintenance, ensuring compliance with MBQ SOPs, local regulatory requirements and ICH-GCP guidelines.
- Contribute to the preparation and maintenance of Investigative Site Files, Investigator Manuals, Clinical Management Plan, Monitoring Guidelines, and Study Training Manuals.
- Supports investigators in fulfilling regulatory submissions, according to local regulatory and IRB/IEC requirements, and ensures all essential trial documentation is prepared and dispatched, as specified by the sponsor company.
- Performs study tracking of all critical documentation received and sent.
- Documents sponsor, vendor, and site contact and interaction in a timely manner.
- Liaise with MBQ staff, vendors, sponsor, and investigative sites to meet study goals and timelines.
- Provide investigative sites with study documents, as required.
- Contribute to planning, logistics and execution of Study Kick-off Meetings, Investigator Meetings and GCP Training Meetings.
Education Requirements and Qualifications
- Must be fluent in written and spoken English
- Undergraduate degree or international equivalent in a science or health-related field
- Relevant clinical administration experience
- Appropriate IT skills as required to perform duties
- Understanding of company SOPs
- Good written and verbal communication skills
For confidential consideration, please submit your resume along with salary requirements to email@example.com
NO PHONE CALLS PLEASE.