Description
Primary responsibilities:* Interact with clinical study investigators and study coordinators through frequent communication and maintains effective management of study issues from start-up to close-out.
* Assist in the development, maintenance and aggregation of key study metrics.
* Assist in updating, monitoring and tracking clinical trial progress and providing status update reports and study metrics.
* Assists in the review of eCRFs and eCRF guidelines.
* Design the Informed Consent Template for the assigned study(ies).
* Review and approve site Informed Consent Forms for submission to site IRBs.
* Coordinates and reviews regulatory documents from study sites; ensures completeness and accuracy.
* Performs data management line listings review of eCRF data in the clinical database for completeness and accuracy, with oversight from Manager.
* Prepares monitoring reports per SOPs and/or reviews reports written by field monitors.
* Communicates status of clinical study and issues to clinical study team. * Ensure all trip reports are reviewed and all action items are followed up per SOPs.
* Communicate deviations from the protocol, SOPs, GCP/ICH, and the applicable regulatory requirements to the Investigator as required.
Skills / Education required:
Must have a minimum of a Bachelors Degree, preferably in a relevant biological or health science discipline. This position requires 3-5 years working CRA I experience in a pharmaceutical or biotech environment. Candidates must have excellent written and oral communication skills in English. Must be well versed in Microsoft Office applications.