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Job Description Summary
Job Description
The Senior Clinical Trial Coordinator assists the clinical research team to ensure that the study is conducted in accordance with GCP, all relevant SOPs, the protocol and in respect of the budget and timelines. They will collaborate with the Study Start-Up team. and ensures the start-up activities are performed both with quality and on time. They will oversee and mentor junior Clinical Trial Coordinators and junior team members as needed.
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 required; 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
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
Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting up to 30 lbs.
Languages
EnglishEducation
Bachelor of Science (BS), Bachelor of Science (BS): Biology, Bachelor of Science (BS): MedicineContract Type
RegularSalary Range
The final offer will be determined within the applicable location-specific range and will depend on the candidate’s confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope.
Italy: EUR 40k - 50kSkills Required
- Bachelor degree in a scientific or health field
- Previous experience in clinical research (CRO, Pharma, academic/hospital)
- Good knowledge of ICH GCP and relevant regulations
- Good knowledge of Clinical Research and Regulatory/Ethical requirements
- Experience with CTMS (Clinical Trial Management System) or similar tools
- Proficiency with MS Office Suite
- Proficiency in English
- Strong organizational, analytical, communication and interpersonal skills
