Clinical Research Associate

·        The in-house Clinical Research Associate (CRA) is responsible for providing support for day to day clinical study activities under general supervision of the the Clinical Project Manager(s).

·        The CRA also provides support for existing departmental tasks and may take on developmental tasks as appropriate upon discussions with manager.

·        The CRA performs work within established protocols under general supervision.

·        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 vendors. (E.g. Clinical Trial Insurance, IWRS specs, Lab Manual, Licensing Agreements etc.) Provides oversight of Clinical CRO Investigator background checks.

·        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 restudy 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 Manager.

·        Liaises with Transparency group to ensure Clintrials.gov is updated.