Description
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
The essential functions of this role include:
- Conducting site monitoring visits in accordance with contracted scope of work and regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Working with sites to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability
- Administering protocol and related study training to assigned sites and establishing regular lines of communication with sites to manage ongoing project expectations and issues
- Evaluating the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
- Managing the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
- Ensuring copies/originals site documents are available for filing in the Trial Master File (TMF) and verifying that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
- Creating and maintaining documentation regarding site management, monitoring visit findings, and action plans
- Collaborating and liaising with study team members for project execution support as needed
The potential base pay range for this role, when annualized, is $74,500.00 - $175,100.00.