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customer service gcp clinical trials ich fda📋 Description
- Collaborates on review, analysis, and interpretation of study results.
- Supports Phase I–III trials and designs upcoming studies.
- Monitors and reviews data including labs, safety, and eligibility.
- Authors/reviews protocols, CRFs, informed consent, deviations, regulatory docs.
- Contributes to CSRs, Investigator’s Brochures, and IND/CTA sections.
- Interacts with external medical advisors and investigators to execute the plan.
🎯 Requirements
- Advanced degree (MD/PhD/PharmD or MSc in science/medical field)
- MD/PhD/PharmD with 3+ years in Clinical Research, Pharma, or CRO; OR MSc with 8+ years
- Knowledge of Phase 1–3 drug development
- Knowledge of trial implementation and sponsor/site interactions
- Experience in neurology or neurodegenerative indications
- Proficient in GCP, ICH, FDA, EMEA guidelines
- Strong collaborative team-player
- Excellent attention to detail and communication
🎁 Benefits
- Remote work opportunities in the United States
- Travel to Cambridge, MA a few times per year
- Private, reliable internet and privacy at remote site
- Equal Opportunity Employer; accommodations available
- Collaborative, cross-functional clinical development team
- Opportunity to advance in neurology/neurodegenerative therapies
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