Clinical Research Associate / Senior Clinical Research Associate (In-House)


The candidate must have prior experience supporting clinical studies, CROs and vendors ideally within a sponsor company. The experience must include all phases of clinical study conduct from start-up to close out, data clean up, and report generation. A good understanding of FDA regulations and a thorough knowledge of GCPs are required along with strong interpersonal and organization skills. Attention to detail is imperative.

Responsibilities
Primary responsibilities of the in-house Clinical Research Associate are to help plan, execute and manage of all the company’s clinical trials in conjunction with the Clinical Trial Manager and Medical Monitor.

 

Specific responsibilities include:

  • Provides support to the Trial Manager and Medical Monitor as needed.

  • Collects, tracks and reviews essential study documents collected directly from study sites or forward by the CRO. Reviews CRO progress reports and assists in the tracking and reconciliation of clinical data, sample collection, and lab results.

  • Assist in the preparation of study-related documents including case report forms, study manuals, laboratory documents, and template informed consent forms.

  • Assist with the development of CRA and site training materials and ensure all study metric trackers, contact lists, checklists and systems are up to date

  • Performs co-monitoring visits, as needed.

  • Reviews monitoring reports, follow up letters and reports from other outside vendors.

  • Provides guidance to study monitors and investigative study sites to ensure consistency in interpretation of the protocol and study procedures.

  • Coordinate and track study drug and other clinical study supplies.

  • Participate in data reviews.

  • Ensures safety letters are forwarded to investigators within the appropriate regulatory timelines.

  • Plans and organizes study related meetings; takes detailed notes at meetings on decisions and action items and distributes the list to the team in the form of minutes.

  • Helps Clinical Trial Manager with providing management updates on study progress.

  • Responsible for oversight and maintenance of Central Files (eTMF), including ensuring files are inspection-ready for filings

 

Education / Experience / Skills:

  • Minimum BA/BS in scientific or health-related field.

  • Clinical Research Associate: A minimum of 2 years combined clinical research experience in a sponsor company, CRO, or at an investigative study site.

  • On-site monitoring experience is preferred.

  • Willing to travel (up to 20 %)

  • Working knowledge of FDA regulations and ICH GCP guidelines

  • Experience managing CROs and other vendors.

  • Some experience in early oncology studies and/or Phase 1/early Phase 2 trials.

  • Strong oral and written communication skills.

  • Ability to multi-task and take on new responsibilities as needed in a fast-paced, small company setting.

  • Good organizational and time management skills.

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