Clinical Research Coordinator II
$66,560,000–$74,880,000 year
On-siteWatertown, Massachusetts, United States
Job Summary
Independently manage a portfolio of complex and/or high-volume trials, leading all operational and visit-related activities. Fully own study execution, including screening operations, enrollment progress, and SCF rates. Conduct participant visits, clinical procedures, and eligibility assessments per protocol. Lead study start-up activities, including SIV preparation, regulatory readiness, and staff training. Serve as the primary liaison with study sponsors, monitors, and CROs. Review source and eligibility criteria to ensure accurate screening decisions. Train and supervise CRC Is or RAs, maintaining quality and performance oversight. Lead data entry and query resolution efforts to ensure inspection readiness. Maintain investigational product accountability, including receipt, storage, dispensing, and reconciliation. Identify operational risks and propose corrective actions to maintain study timelines. Compile study metrics across assigned trials and present operational updates to sponsors.
Required Qualifications
- Bachelor's degree
- At least 1 year of prior clinical research experience
- Experience with industry-sponsored clinical trials
- Demonstrated ability to manage complex studies independently
- Strong communication skills
- Comfort interacting directly with sponsors
- Must provide documentation verifying their identity and authorization to work in the United States
- Must complete Form I-9 within the required timeframe
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