Clinical Research Associate

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 Clintrials.gov 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.

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