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

Our client, a world leader in biotechnology and life sciences, is
looking for a “Medical Affairs Associate (100% Remote)”.

Job Duration: Long Term Contract (Possibility of Extension)

Pay Rate: $36.70/hr on W2

Company Benefits: Medical, Paid Sick leave(as
per state policy)

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.

Key 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.
  

Required 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.
  

Preferred Qualifications

• 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.
  

If interested, please send us your updated resume at

[email protected]/[email protected]