As a CRA II your responsibilities will be the following:
* Review completion of proper informed consent procedures.
* Perform site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance. Visits may be performed on-site or remotely.
* Ensure accurate data reporting via review of site source documents and medical records.
* Interpret data to identify protocol deviations and risks to subject safety/data integrity.
* Generate queries and manage resolutions with site personnel.
* Perform investigational product accountability as per the protocol and Study Monitoring Plan.
* Evaluate execution of study protocol at the site level. Use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team.
* Obtain, review, and process essential regulatory and administrative documents. Conduct audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance.
* Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and Study Monitoring Plan.
* Understand project scope, budgets, and timelines; manage site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing variables to achieve goals / targets. Enter data into tracking systems as required.
* Act as primary liaison with study site personnel.
* Enter data into tracking systems as required.
* Participate in the identification and selection of investigators and clinical sites.