In-House Clinical Research Associate

at  WEP Clinical

Are you passionate about supporting the successful execution of clinical trials and ensuring the development of life-changing therapies? At WEP Clinical, we are dedicated to helping patients gain early access to innovative treatments. We offer a collaborative environment where your contributions are valued, and we provide opportunities for both professional growth and personal fulfillment. Join our team as an In-House Clinical Research Associate and play a key role in advancing medical research while making a real impact on patients’ lives!

ROLE OBJECTIVES:

The WEP Clinical In-House Clinical Research Associate (In-House CRA) coordinates aspects of clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA/MHRA/EMA guidelines, local regulations and WEP Clinical Standard Operating Procedures.
The In-House CRA provides operational support to ensure the effective and efficient delivery of clinical site monitoring and regulatory requirements as well as manages required documentation.
The In-House CRA will be a part of a multi-disciplinary team that provides scientific, statistical, operational, and support for clinical trials and Expanded Access Programs (EAP).

WHAT YOU’LL DO:

• Support the project team in the feasibility and site process, including collecting relevant data and tracking site feasibility progress.
• Schedule and ensure on-site or remote monitoring visits (Investigator Meetings (IM), Qualification Visits (QV), Site Initiation Visit (SIV), Interim Monitoring Visit (IMV), and Close Out Visit (COV)) occur in accordance with project timelines and requirements.
• Facilitating or scheduling site trainings required per study protocol.
• Support the development of required documentation such as protocols, informed consent forms, case report forms.
• Support the development of required monitoring related documentation such as Monitoring Plans, Visit Reports, Confirmation Letters, Follow-Up Letters, and Action Item Logs.
• Coordinate with sites to resolve queries, actions items, data discrepancies and protocol deviations.
• Ensure accurate documentation and reporting of safety events according to protocol and regulatory requirements.
• Ensure timely, consistent and maintenance of Trial Master File for monitoring related documents.
• Ensure timely, consistent and maintenance of Clinical Trial Management System for monitoring related activities.
• Address protocol or monitoring related questions received from sites for assigned programs.
• Proactively identifies and communicates site performance and monitoring issues to key stakeholders and implements action plans in conjunction with the project team.
• Perform miscellaneous job-related duties as assigned.