Senior Clinical Trial Coordinator

• Responsible (under PM oversight and in conjunction with the Study Start-Up Team) for start-up activities, including Ethic and Regulatory submission (at national and international level) and sites contract negotiation.

• Responsible for ISF preparation and TMF set up and maintenance (under PM oversight).

• Training and support of junior CTCs for use of tools, e.g. CTMS.

• Maintains relationship with ECs and CA  for e.g device, observational, real-world evidence studies.

• Supports in sites/vendors invoicing management and responsible to maintain an appropriate tracking if required.

• Responsible for vendor management (under PM oversight).

• 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 ; participates to audit.

• Performs additional duties as assigned.

• 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

WORKING CONDITIONS/PHYSICAL DEMANDS 

Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting up to 30 lbs.