Randstad Clinical Operations in Raleigh, North Carolina

Clinical Operations

job details:

  • location:Raleigh, NC

  • salary:$53.13 - $62.50 per hour

  • date posted:Wednesday, June 13, 2018

  • job type:Contract

  • reference:25427

job description

Clinical Operations

Sr. Endpoint Adjudication Specialist

Job Summary

Be responsible for the identification of potential clinical events, as well as the collection, review and preparation of required documentation for review by clinical event or adjudication committees. Additionally, may assist the Endpoint Adjudication Manager in management of the activities of the Endpoint Adjudication team

  • 2 of these positions will be dedicated to QCing endpoint cases and narratives.

  • 1 position will be for an SME to manage all aspects of joint safety events/narratives.

  • 1 position will be for an SME to manage all aspects of neuro safety events/narratives

Job Responsibilities .

  • Focused on intake/miscellaneous administrative tasks associated with safety case processing.

  • Approx. half of these should have very strong monitoring experience, similar to that of a strong CRA.

  • They will be expected to complete remote source data verification and review of patient medical records against the database.

  • Assist with the development of rigorous and study-specific endpoint or event reporting and adjudication processes

  • Develop forms and tracking reports required for the execution of the endpoint or event reporting and adjudication process

  • Assist with training and oversight of day-to-day tasks of all Endpoint or Event team members

  • Receive and review Investigator Record of Potential Endpoint or Event forms from investigator sites

  • Follow-up with Investigator sites to obtain additional supporting, documentation for potential endpoints or events

  • Review medical information to ensure completeness of endpoint or event package, blinding of study subject, and to identify any unreported potential endpoints or events

  • Review Serious Adverse Event (SAE) listings and provide appropriate follow-up with the Investigator site to ensure that all potential endpoints or events have been reported

  • Assemble endpoint or event adjudication packets for Clinical Events Committee Members

  • Play a lead role in the preparation for periodic Clinical Events Committee Member meetings. May also attend the committee meetings as a facilitator

  • Assist the Endpoint Adjudication Manager in the management of the activities of the endpoint adjudication team; or may act as the Endpoint Adjudication Manager for small-scale endpoint management projects

  • Generate tracking reports for internal or client purposes

  • Train and mentor junior Endpoint Adjudication staff on study-specific and internal procedures.

Education & Qualifications

  • Bachelor's degree or RN

  • 5 years of prior experience working in an endpoint/event processing role or other relevant pharmaceutical industry experience

  • Excellent organizational skills

  • Ability to manage time and work independently

  • Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade

  • These positions will require someone who is flexible, works well under pressure and can be a main contact for the client.

  • All are client facing and will attend sponsor calls.

  • 2 must be based on the East Coast, when submitting candidate please share details regarding location.

Benefits

  • Medical, Dental, and Vision Insurance

  • 401K Plan with Company Match

  • Life and AD&D Insurance