Remotely
ms officectmsmedidata raveedcetmfirtoracle inform
Job Description
📋 Description
- Oversee clinical site monitoring and management across studies (onsite and remote).
- Coordinate site qualification, initiation, routine monitoring, and close-out visits.
- Ensure activities comply with SOPs, study plans, ICH-GCP, and local regulations.
- Review data against source documentation; resolve data queries and issues.
- Monitor and facilitate shipment of clinical supplies and study documents.
- Train site staff on protocols, systems, and ICH-GCP requirements.
🎯 Requirements
- 4–6 years of relevant clinical research experience; 7–9 years preferred.
- Bachelor’s degree in Health/Life Sciences, Pharmacy, Nursing or related; Master’s advantageous.
- Senior CRA or ACRP certification a plus.
- Strong knowledge of ICH-GCP and local regulatory requirements.
- Experience with Phase I–IV trials; proficient with EDC (Medidata Rave, Oracle InForm), IRT, eTMF
- Fluent English; valid driver’s license; ability to travel ~40–60%.
🎁 Benefits
- Salary: $58,000–$96,500 per year (depends on experience, location).
- Home-based work; regular travel to clinical sites and meetings.
- Professional growth and mentoring opportunities in clinical research.
- Cross-functional collaboration with sponsors, investigators, and regulatory teams.
- Opportunity to contribute to process improvements and best practices.
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