Remote Medical Affairs Associate, Clinical Operations

ATR International; San Mateo (CA); Remote; USD 42,000 - 59,000; Full time

Job summary

ATR International is seeking a Medical Affairs Associate to support operational execution across expanded access programs, OOS case work, and single‑patient IND processes. The role collaborates with cross‑functional study teams, monitors CRO performance, and maintains regulatory alignment from startup through closure.

Remote work with West Coast preference. Strong experience in clinical operations and familiarity with CTMS/EDC/RDMS is required to drive milestones and ensure compliance in a

Qualifications

• BS/BA or RN in Nursing, Science, or a health‑related field.
• 3–5+ years of related Clinical Operations or Medical Affairs experience.
• Familiarity with clinical systems such as CTMS, EDC (Medidata RAVE), and RDMS.

Responsibilities

• Support clinical trials and expanded access programs from startup to closure; coordinate deliverables and timelines.
• Assist with OOS, expanded access, and single‑patient IND requests with cross‑functional follow‑up.
• Review startup and study documents including protocols, ICFs, IBs, and CRFs.
• Manage external partners and CROs to monitor timelines and performance.
• Create site feasibility assessments and respond to site queries in line with ICH GCP.
• Track enrollment, data flow, deviations, and queries for database locks; report status.

Skills

Clinical Operations

Medical Affairs

Vendor Management

Regulatory Understanding

Education

Bachelor’s degree or RN

Tools

CTMS

EDC (Medidata RAVE)

RDMS

Job description

ATR International is seeking a Medical Affairs Associate to support operational execution across expanded access programs, OOS case work, and single‑patient IND processes. The role collaborates with cross‑functional study teams, monitors CRO performance, and maintains regulatory alignment from startup through closure.

Remote work with West Coast preference. Strong experience in clinical operations and familiarity with CTMS/EDC/RDMS is required to drive milestones and ensure compliance in a