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Job Description Summary
Job Description
ROLE
The Clinical Trial Coordinator assists the clinical research team ensuring to conduct study in accordance to GCP, SOP, protocol, and in respect of budget and timelines. The Clinical Trial Coordinator is responsible of start up activities and documents management.
KEY RESPONSABILITIES
- Responsible (under PM oversight) of start up activities, including Ethic and Regulatory submission (at national and international level) and sites contracts’ negotiation.
- Responsible for ISF preparation and TMF set up and maintenance (under PM oversight).
- Maintains relationship with ECs and CA.
- Supports in sites/vendors invoicing management and responsible to maintain an appropriate tracking if required.
- Collaborates with the preparation of weekly/monthly and ad hoc project reports, also updating CTMS and maintaining study-specific trackers as needed.
- Supports with CRAs activities follow-up.
- Supports with document translation, if required.
- Participates in internal, client/sponsor, scientific, and other meetings as required; participates to audit.
- Performs additional duties as assigned
DESIRED QUALIFICATION & EXPERIENCE
- Graduation in scientific/health field
- Previous experience in clinical research (in CROs, Pharma or academy/hospital experience)
- Good knowledge of ICH GCP and appropriate regulations
- Good knowledge of Clinical Research and Regulatory/Ethical requirements
TECHNICAL COMPETENCES & SOFT SKILLS
- English, good
- MS Office Suite, Good
- Professional
- Trustworthy
- Quality focused; ability to be careful, thorough, and detail-oriented
- Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment; able to manage priorities and organize time
- Strong analytical skills
- Strong communication and interpersonal skills with customer service orientation
Languages
English
Education
Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Pharmacy
Contract Type
Regular