On-Site: Clinical Research Specialist (235055)

Life Sciences & Technology


  • 6+ Months temp to perm


  • 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.


  • 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


  • Clinical Research Specialist, Class III implantable, Data support (query, reports, entry, etc..) Site management


  • Bachelors in related field


On-Site: Clinical Research Specialist (235055)


About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
US On-Site

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