[Hiring] Medical Affairs Associate @Dawar Consulting, Inc.

Role Description

Seeking a Medical Affairs Associate to support clinical operations and Medical Affairs programs, including Expanded Access Programs, Out-of-Specification (OOS) case support, and Single-Patient IND requests. This role will coordinate study activities, vendors, clinical sites, documentation, timelines, and cross-functional deliverables while ensuring compliance with applicable regulations and procedures.

• 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.

Qualifications

• Bachelor's degree in Nursing, Life Sciences, or a related healthcare field.
• 3–5 years of Clinical Operations / 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.

Requirements

• 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.

Benefits

• Medical
• Paid Sick leave (as per state policy)