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