Clinical Research Associate II
On-siteBoston, Massachusetts, United States
Job Summary
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, and inspection of study files. Initiate studies by performing initiation site visits, arranging shipment of clinical supplies and case report forms, and procure budgets, contracts, and regulatory documents. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in protocol and case report form design, evaluate potential clinical sites, and conduct study termination visits to obtain final reports from investigators. Prepare site visit reports with key accomplishments, issues for resolution, and follow-up recommendations. Maintain clinical archive and electronic files. Requires BA, BS, RN, BSN, or equivalent with 1-2 years of clinical research experience and GCP knowledge.
Required Qualifications
- BA, BS, RN, BSN or equivalent
- Basic knowledge and adherence to GCPs
- 1-2 years of clinical research experience or equivalent experience or training
- Strong attention to detail
- Ability to multi-task
- Unquestionable integrity and highest ethical standards
- Excellent written and verbal communication skills
- Self-motivated, assertive, and driven
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