Positions Currently Open
CLINICAL RESEARCH ASSOCIATE II or III
(level dependent upon experience)
LOCATION: REGIONAL (HOME-BASED, NEAR A MAJOR AIRPORT)
ACCOUNTABILITY:
Prologue’s Clinical Research Associates (CRAs) perform monitoring at clinical sites to ensure that data collected is accurate, complete, and GCP compliant. This position requires approximately 70% travel.
KEY RESPONSIBILITIES:
- On-site monitoring to ensure compliance with GCPs, study protocol, and SOPs including source document review and/or case report form data for integrity and consistency.
- Generate and resolve queries.
- Serve as contact with sites to provide support during the conduct of the clinical trial and serve as a resource for the clinical sites for protocol and procedural questions.
- Track and account for the review of all CRFs for studies assigned.
- Provide training to sites on study conduct, CRF completion and data management expectations.
- Prepare expense reports, visit reports and schedule subsequent visits in accordance with client expectations and within the confines of the study budget.
- Monitor available drug supply at the clinical sites.
- Assist in the identification of potential investigators and criteria to qualify the site.
- Assist in the preparation of instruction manuals, monitor plans and newsletters. Develop and adapt monitoring tools.
- Participate with start-up study activities.
- Review in-house data.
MINIMUM REQUIREMENTS:
Education
- Bachelor’s degree, biological science or nursing preferred
Experience
- 3 years CRA experience; 2 years oncology experience
Skills
- Strong organizational skills and attention to detail
- Strong verbal and written communication
- Demonstrated knowledge of GCPs, clinical protocols, case reports forms
- Demonstrated ability to work independently as well as part of a team
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