Positions Currently Open
CLINICAL RESEARCH ASSOCIATE II
LOCATION: NATIONWIDE (home-based, near major airport)
ACCOUNTABILITY:
Monitor clinical trial site activity to ensure that data collected is accurate, complete, and GCP compliant. Requires approximately 70% travel.
KEY RESPONSIBILITIES:
- Conduct monitoring at clinical trial site 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 in start-up study activities.
- Review in-house data.
QUALIFICATIONS
- Bachelor’s degree, biological sciences or nursing preferred
- 3 years current monitoring experience; 2 years oncology clinical trials experience
- 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
- Ability to travel up to 70%
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