Clinical Research Associate

Highly Competitive Salary
  1. Permanent
  2. Clinical Trial Assistant (CTA), Clinical Research Associate (CRA), CRA Manager
  3. United States
Boston, USA
Posting date: 10 Feb 2021

Proclinical is currently recruiting for a Clinical Research Associate with a pharmaceutical company located in Boston, MA.

Job Responsibilities:

  • Assists the study team(s) to deliver the clinical study within agreed timelines.
  • Assists in authoring/contributing to clinical study documents and study related plans developed by Clinical CROs and (E.g. Clinical Trial Insurance, IWRS specs, Lab Manual, Licensing Agreements etc.)
  • Provides oversight of Clinical CRO Investigator background
  • Assists in oversight of vendor shipment of clinical supplies (e.g. lab kits, test machines, equipment etc.) being sent to sites prior to initiation as necessary.
  • Provides oversight of Essential Documents for Investigational Medicine Release as per relevant SOP.
  • Reviews Clinical Monitoring Reports and correspondence related to Pre-Study and Initiation Visits and follows-up with Clinical CRO to resolve open action items.
  • Manages escalation of study related issues and communicates as appropriate with Clinical Project Manager.
  • Responsible for the operational oversight of the Clinical CRO with regards to data feed setup in the Clinical Trial Management System. Assists and/or participates in planning and conduct of Investigator's Meetings as necessary.
  • Assists Clinical Project Manager in tracking study related activities which are not appropriate to be outsourced.
  • Reviews a percentage of monitoring visit reports for oversight and escalates issues to Clinical Project Manager.
  • Assists with agenda distribution & minute taking for internal clinical study team meetings where formal documentation is needed and the Clinical CRO is not present.
  • Provides oversight of Clinical CRO activities regarding amendments to confidentiality and site agreements.
  • Assists study team with preparation for audits/inspections
  • Reviews clinical close out monitoring visit reports for oversight and escalates issues to the Clinical Project
  • Liaises with Transparency group to ensure and results are updated/distributed accordingly.
  • Development tasks may be assigned to a CRA as appropriate upon discussions with manger:
  • Assist in providing oversight of CRO activities regarding country and site specific informed consent documentation tracking, finalization and approval.

Skills and Requirements:

  • Bachelor's degree required
  • 1-3 year's experience in similar/relevant field (eg.Sponsor, CRO, Clincal trial Vendor,
    Clincal Coordinator, etc.)

If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.