Key Responsibilities

• Coordinate all assigned clinical trials from study start-up through closeout.
• Recruit, pre-screen, and schedule study participants.
• Conduct informed consent discussions and study visits.
• Perform protocol-required procedures within scope of training, including vital signs, ECGs, specimen collection, processing, and investigational product administration when applicable.
• Maintain accurate source documentation and enter study data into sponsor electronic data capture systems.
• Resolve data queries and ensure timely, high-quality data submission.
• Monitor and report adverse events, serious adverse events, and protocol deviations according to protocol and regulatory requirements.
• Collect, maintain, and submit regulatory documentation to sponsors and IRBs.
• Coordinate study vendors and ensure protocol requirements are met.
• Train and support delegated study staff as appropriate.
• Maintain patient confidentiality and protect sponsor and company confidential information.
• Collaborate effectively with investigators, patients, sponsors, CROs, and internal team members.