The Clinical Research Associate (Contract) is responsible for management and oversight of company-sponsored domestic and international clinical trials. The position will require frequent travel to clinical sites covering the East Coast area.
TRAVEL REQUIREMENTS - High Travel requirements: This position may require extensive domestic and international business travel of 50% or more of the time.
- Monitor (pre-study, initiation, routine, and close-out visits) investigator sites for Good Clinical Practice (GCP) compliance according to Company SOPs and relevant FDA, and international, regulations.
- Recruit investigators to participate in Company-sponsored studies.
- Obtain, review, and process regulatory and administrative documents from investigator sites.
- Prepare and/or review Serious Adverse Event (SAE) reports.
- Author monitoring trip reports.
- Review and verify completed CRFs.
- In conjunction with the Biostatistics Department, periodically review the completeness of all entered or monitored data.
- Evaluate data and/or monitoring reports for protocol violations and serious protocol deviations, and proactively address violations/deviations.
- Resolve queries of CRF data with study site personnel.
- Train and mentor CRAs on monitoring, internal procedures, and query resolution.
- Perform other duties as may be assigned by management.
- Interact with statisticians in analysis of clinical data.
Minimum Requirements and Qualifications:
Desired Requirements and Qualifications:
- Bachelor’s Degree in a physical science or RN.
- Ability and willingness to travel up to 50% of the time, as needed.
- 2+ years’ experience in monitoring or in-house management of clinical trials.
- Excellent organizational skills.
- Excellent written and oral communication skills.
- MS Office proficient.
- Familiarity with commercial data-management or EDC systems.
- Prior experience overseeing a Class III device or pharmaceutical clinical trial from inception of study to completion.
- Working knowledge of Investigational Device Exemption (IDE) regulations.
- Prior experience drafting Informed Consent documents
- Working knowledge of Good Clinical Practices (GCPs)
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