Job Description
The Clinical Research Associate II is a key member of the Clinical Operations group, responsible for site management, monitoring tasks, and operational support of clinical trials. Key responsibilities include:
* Coordinate the identification, feasibility assessment, and selection of investigators and sites to undertake the trial.
* Complete all monitoring activities per the Monitoring Plan along with completing monitoring visit reports, accurately and within the predetermined timeframe.
* Prepare, plan, organize, and conduct site evaluation visits and report on these visits to assist in site selection.
* Prepare, submit, and/or liaise with regulatory specialist colleagues, regarding the preparation of regulatory packages, importation/exportation requirements, and updates of Ethics Committee packages.
* Negotiate site budgets, coordinate for site contract execution, track invoicing, and ensure timely site payments.
* Prepare, plan, organize, and conduct site initiation visits.
* Develop and maintain appropriate monitoring tools and project-specific documents.
* Motivate and train investigators to ensure that the trial site personnel have a good understanding of the protocol, investigational product, and requirements of the trial so they can fulfill their obligations to conduct the trial accurately and to deadlines.
* Collect, review, and approve essential documents from trial sites, to ensure quality and compliance, and code documents for Trial Master File (TMF) filing.
* Reconcile contents of in-house TMF and site's Investigator Site Files.
* Coordinate distribution, tracking, handling, and destruction of investigational product and other trial supplies per site/trial requirements.
* Maintain trial information using the clinical trial management system and any other tracking and reporting tools for the trial.
* Support strategies to boost recruitment efforts.