Contract Clinical Research Associate (50%)
Job #: 10705
Job Type: 1099
Therapeutics: No Specific TA Required
One of our partner organizations needs a contract CRA to monitor epidemiology studies in the Tampa Bay, Orlando, and Miami, FL areas at 50% utilization.
- Effectively and efficiently assist in managing technical, financial, and functional aspects of all current/new studies from start-up through close, with focus including but not limited to, data management, clinical operations, regulatory compliance and SOPs.
- Ability to properly negotiate budgets for research studies.
- Assist with the development of study manuals, CRFs, monitoring standards, site study tools and other study materials as required.
- Develop and/or revise training material, technology enablement, and SOPs.
- Develop and implement site recruitment, selection and initiation plan.
- Manage and drive subject recruitment and enrollment tracking.
- Schedule team meetings and ensure successful communication and mobilization.
- Provide training to sites on the study protocol, study conduct, CRF completion and data management expectations, budgeting and contract review.
- Ensure essential document collection for completeness per regulatory requirements.
- Demonstrate knowledge of on-site monitoring to ensure compliance with GCPs, study protocols, and SOPs and serve as a resource for protocols and procedures.
- Monitor product supplies/accountability including proper storage, dispensation, and disposal.
- Manage study completion activities including CRF collection, query resolution, record archiving and site closeout activities.
- Audit in-house data for current studies and advise.
- Mentor, coach, provide guidance and train research staff as appropriate.
- Looking for CRAs who are in the Tampa Bay, Orlando or Miami area
- Ability to travel up to 30% as required (mostly local)
- 3 years' experience as a fully dedicated CRA for a CRO or Sponsor is required (with monitoring experience being recent).
- Must have experience performing Study Startup Activities such as site selection, budget and contract negotiations, TMF / Reg binder setup, assisting site(s) with IRB submissions, etc.
- Experience monitoring federally funded project required; NIH experience preferred
- GCP certification (or able/willing to obtain before start of the project
- Minimum Bachelors of Science in a life sciences or health related field (equivalent experience will be considered)
- CRA Certified (ACRP or SOCRA) preferred
- Phlebotomy Certified (preferred for future growth for ‘ideal research staff member’)
- GMP or GLP experience would be a plus
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