Medical Affairs Associate

This is a fully remote position, open to applicants in California.

📋 Description

• Assist in the management of clinical trials from the initiation phase to final closeout.

• Oversee Expanded Access Programs, Out-of-Specification cases, and Single-Patient IND procedures.

• Review and uphold essential documents related to clinical studies, such as protocols, Informed Consent Forms (ICFs), Investigator Brochures (IBs), and Case Report Forms (CRFs).

• Coordinate with Contract Research Organizations (CROs), vendors, investigators, and clinical trial sites.

• Monitor enrollment, screening processes, data flow, protocol deviations, key milestones, and study deliverables.

• Assist with site feasibility assessments, investigator meetings, site communications, and training sessions.

• Identify program risks, address operational challenges, and escalate issues when necessary.

• Generate study metrics, status reports, newsletters, and updates for management.

• Aid in addressing clinical data inquiries and overseeing database lock procedures.

• Ensure adherence to relevant regulations and organizational procedures.

⛳️ Requirements

• Bachelor's degree in Nursing, Life Sciences, or a related healthcare discipline.

• 3–5 years of experience in Clinical Operations or Clinical Trials.

• Knowledge of Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), and clinical trial documentation.

• Excellent organizational, communication, and problem-solving abilities.

• Capability to handle multiple priorities within a dynamic environment.

• Experience in oncology or hematology clinical trials is preferred.

• Prior involvement with cellular therapy is preferred.

• Familiarity with iMedidata / RAVE EDC is preferred.

• Experience with study start-up in a CRO, sponsor, or site-based regulatory context is preferred.

• Background in transplant patient care or apheresis collection is preferred.

🏝️ Benefits

• Medical coverage.

• Paid sick leave according to state policy.

• Potential for contract extension.