Clinical Research Associate 11Apply Now
Location: Bedford, Massachusetts 01730
Employment Type: Contract
Contract Length: 12 months
The Clinical Research Associate (CRA) II will assist the Clinical Project Manager in the conduct of clinical trials.
- Conduct independent monitoring to verify accuracy of study data vs. source records
- Ensure HIPAA requirements for patient privacy are met
- Generate and collect study documentation such as consent forms, Essential Documents, Case Report Forms and Investigator Agreements
- Tracks progress of sites to initiation, enrollment and screening, interim monitoring and close out requirements
- Ensure no study tasks are conducted prior to IRB/EC approval, CA/FDA approval, and formal site activation
- Review Serious Adverse Event (SAE) narratives with sites and medical monitor; Ensure adverse event reporting is done in accordance with regulatory requirements
- Maintain documentation in electronic and paper Trial Master Files
- Maintain close communication with study sites, investigators, and vendors
- Organize, conduct and report on Site Qualification, Site Initiation, Interim Monitoring, and Close-out visits
- Identify and resolve site issues
- Manage all aspects of relationship and operational activities for designated clinical investigational sites
- Bachelor's degree in the life sciences
- 2+ years Registered Nurse or other relevant experience
- Demonstrated detailed knowledge of guidelines, systems for clinical trial management and of ICH GCP, FDA, and international regulations and practices
Desired Experience, Knowledge, and Skills:
- 2+ years of current clinical trial monitoring experience
- Strong medical and clinical knowledge of indications, therapies, and patient population
- Proven track record of having good sponsor, investigator, site, and vendor relations
- Strong computer skills including EDC system experience
As a Senior Recruiter, Michael Liuzza brings almost a decade of sourcing and hiring experience to the JVT team. In his current role, Michael is responsible for full lifecycle recruiting, partnering with JVT's Contract Recruiting Team to match superior available talent with career building opportunities.
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