Duration
- 6+ Months temp to perm
Location
- Hybrid
Job Description
- Our client is seeking a Clinical Research Specialist to support post market site safety activities. This candidate will be working with 10-12 research sites to collect and review data, support patient requests, and work with internal/external teams on report generation. This is a long-term post-market study on an approved Class III implantable device. The idea candidate must have at least 5 years of trial experience, working knowledge of Medidata RAVE EDC, ERT vendor software, and work to support operation and back/front room GCP activities. Candidate with previous Class III implantable devices and or post market experience with plastic surgery based products will be prioritized.
Responsibilities
- Experience in managing CRO project timelines, reviewing monitoring reports, and developing pre-visit tools and annotated trip reports
- Vendor management experience ideally with CRO’s and ERT’s (e.g. Clario)
- Experience in developing subject retention strategies and working with vendors to ensure compliance to ePRO questionnaires
- Develop or contribute to study documents such as a monitoring plan, protocol/annual report (clinical sections), CRF guidelines, source worksheets
- Direct backroom (front room is a bonus but not required) experience in audit and/or inspections and participated in audit readiness activities
- Experience in Medidata RAVE EDC, Medidata OneCTMS, and Veeva Vault eTMF (preferred)
- Direct site management experience (~10-14 sites is typical) including but not limited to data entry guidance, query resolution, escalation of site issues to Management, etc.
- Must have recent class III medical device experience
Skills
- Clinical Research Specialist, Class III implantable, Data support (query, reports, entry, etc..) Site management
Education
- Bachelors in related field
On-Site: Clinical Research Specialist (235055)
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