North AmericaFull TimeHealthcare
Remotely
gcpclinical monitoringregulatoryipcapactmsich gcp
Job Description
📋 Description
- Lead planning, conduct and oversight of operational portions of clinical studies per scope.
- Ensure studies conform to protocol, SOPs, ICH-GCP and regulatory requirements.
- Coordinate with PM on monthly invoicing and budget variance management.
- Develop study documents and training materials (clinical plans, ICF templates, CRF guidelines
- Drive site feasibility and recruitment/retention planning with stakeholders.
- Oversee site start-up, enrollment, maintenance and close-out procedures.
🎯 Requirements
- Bachelor’s degree in science/health; advanced degree preferred.
- 7+ years clinical research experience with significant monitoring.
- Strong knowledge of ICH-GCP, regulatory guidance, and SOPs.
- Excellent communication, organizational, and negotiation skills.
- Ability to travel domestically and internationally (incl. overnight).
🎁 Benefits
- Competitive compensation and bonus eligibility.
- Health, retirement, life and disability benefits; parental leave; PTO.
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