Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.

ROLE OBJECTIVES:

The Medical Affairs Associate collaborates with the Medical Affairs department and other operational teams to ensure WEP Clinical provides the highest standards of ethical and scientific rigor in the execution of all projects. The Medical Affairs Associate serves as the primary support to Medical Managers and Medical Directors in the execution of clinical trials and different early access programs, playing a relevant role in ensuring their accuracy, integrity, and successful completion. As a Medical Affairs Associate, you will provide scientific support, medical data collection and analysis to enable different activities in the department, such as medical monitoring, pharmacovigilance, site selection/ feasibility, study documents development and our home-health and virtual solutions services. This position encompasses a variety of roles and integrates multiple functions, supporting the Medical Affairs Department in a broad spectrum of activities.

WHAT YOU’LL DO:

• Act as the primary medical contact for investigators, regulatory agencies, and internal/external teams, ensuring protocol clarity and consistent interpretation.
• Monitor clinical trials and Expanded Access Programs (EAPs) for participant safety, data accuracy, and protocol compliance, addressing medical issues as needed.
• Participate in site selection by evaluating investigator experience and conducting calls to review inclusion/exclusion criteria and support patient recruitment.
• Serve as the lead medical expert on the trial protocol, ensuring understanding and adherence across investigators, study teams, and stakeholders.
• Review and assess adverse events (AEs) and serious adverse events (SAEs), ensuring proper documentation, timely reporting, and causality assessment.
• Collaborate with Data Safety Monitoring Boards (DSMBs) and safety committees to oversee participant safety and evaluate ongoing trial data.
• Provide protocol and therapeutic training to investigators, site staff, and cross-functional teams to ensure consistent understanding and compliance.
• Participate in investigator meetings and site initiation visits, clarifying protocol-related issues and addressing medical questions.
• Contribute medical expertise to study documents including protocols, treatment guidelines, and trial design elements.
• Ensure study conduct aligns with the protocol, resolving deviations and maintaining the scientific and ethical integrity of the trial.
• Collaborate with clinical operations, regulatory, pharmacovigilance, and project management teams to ensure GCP compliance and timely safety reporting.
• Support business development and cross-functional teams by providing medical input in bid proposals, client meetings, and protocol-related discussions.