Medical Affairs Associate (100% Remote) - West Coast Preferred

Dawar Consulting•Santa Monica, CA

1d•Remote

About The Position

The Medical Affairs Associate will support clinical operations and Medical Affairs programs, including Expanded Access Programs, Out-of-Specification (OOS) case support, and Single-Patient IND requests. The role coordinates study activities, vendors, clinical sites, documentation, timelines, and cross-functional deliverables while ensuring compliance with applicable regulations and procedures. This position supports clinical trials from study start-up through closeout, coordinating program operations and maintaining essential study documentation. The associate tracks study progress and deliverables, supports site and investigator activities, monitors risks, addresses operational issues, and prepares program updates. The role also supports clinical data queries and database lock activities.

Requirements

Bachelor's degree in Nursing, Life Sciences, or a related healthcare field.
3–5 years of Clinical Operations or Clinical Trial experience.
Familiarity with CTMS, EDC, and clinical trial documentation.
Strong organizational, communication, and problem-solving skills.
Ability to manage multiple priorities in a fast-paced environment.

Nice To Haves

Oncology or Hematology clinical trial experience.
Cellular therapy experience.
iMedidata / RAVE EDC experience.
Study start-up experience in a CRO, sponsor, or site-based regulatory environment.
Exposure to transplant patient care or apheresis collection.

Responsibilities

Support clinical trials from study start-up through closeout.
Coordinate Expanded Access Programs, OOS cases, and Single-Patient IND activities.
Review and maintain essential clinical study documents, including protocols, ICFs, IBs, and CRFs.
Coordinate CROs, vendors, investigators, and clinical trial sites.
Track enrollment, screening, data flow, protocol deviations, milestones, and study deliverables.
Support site feasibility, investigator meetings, site communications, and training.
Monitor program risks, resolve operational issues, and escalate concerns.
Prepare study metrics, status reports, newsletters, and management updates.
Support clinical data queries and database lock activities.