Senior Project Coordinator
Remote: Poland, Spain or GermanyFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- Minimum of 2 years
- Required Skills
- Project ManagementGCPMicrosoft Office
Requirements
- Bachelor’s degree in a field relevant to clinical research or equivalent experience.
- Minimum of 2 years of experience as a Project Coordinator or equivalent in clinical research.
- Proven Site Start-Up experience in clinical trials or staff management.
- Knowledge of essential documentation requirements for clinical trials.
- Proficiency in English (written and oral).
- Excellent knowledge of Word, Excel, and PowerPoint.
- Strong organizational, communication, and problem-solving skills.
- Good knowledge of Good Clinical Practices (GCP).
- Knowledge of Health Canada and FDA regulations/guidelines.
Responsibilities
- Prepare investigator sites for clinical trials through document review and approval.
- Establish site activation timelines and coordinate activities to meet targets.
- Manage communication with clinical sites during site start-up.
- Ensure electronic Trial Master File (eTMF) is complete and current.
- Assist in drafting study documents and study plans.
- Act as main point of contact for non-protocol site correspondence.
- Maintain project timelines, enrollment tracking, and study material inventory.
- Support audits, inspections, and CAPA preparation.
- Mentor junior project coordinators and assist with onboarding.
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