Medical Affairs Associate

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

Job Title: Medical Affairs Associate – Clinical Operations (Remote – West Coast Preferred)

Pay Rate: $36.72 / hour

Location: Remote (West Coast preferred)

Job Type: Full-Time / Contract

About the Client

Join a world-renowned, pioneering biopharmaceutical company dedicated to discovering, developing, and delivering innovative therapeutics in areas of high unmet medical need. Known for groundbreaking advances in oncology, hematology, and cellular therapy, our client offers a fast-paced, collaborative environment where your contributions directly support critical patient access, clinical trial execution, and life‑saving treatments.

Position Summary

We are seeking a Medical Affairs Associate to support key operational execution across expanded access programs, out‑of‑specification (OOS) case support, and single‑patient IND processes. In this role, you will collaborate with cross‑functional study teams, manage external vendor performance (CROs), track critical program milestones, and ensure regulatory alignment from study startup through closure.

Key Responsibilities

• Clinical Trial & Program Management: Support clinical trials and treatment‑use programs from startup to closure; coordinate study‑related deliverables, timelines, and documentation.
• Expanded Access & IND Support: Assist with out‑of‑specification programs, expanded access programs, and single‑patient IND requests, ensuring cross‑functional follow‑up.
• Document Review: Help review essential startup and study documents, including protocols, ICFs, IBs, pharmacy manuals, monitoring plans, and CRFs.
• Vendor & CRO Oversight: Manage external partners and CROs to monitor timelines, transferred obligations, and performance expectations.
• Site & Team Support: Create site feasibility assessments, prepare site newsletters, and assist with site queries in compliance with ICH GCP and study protocols.
• Data & Milestone Tracking: Track screening, enrollment, data flow, protocol deviations, and clinical trial queries for database locks; prepare status metrics for senior leadership.
• Issue & Risk Resolution: Proactively identify study risks, recommend solutions, and elevate issues when necessary.

Basic Qualifications

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

Preferred Qualifications

• Experience in Oncology / Hematology (Cellular therapy, transplant patient care, or apheresis collection is a strong plus).
• Study startup experience from a site, CRO, or sponsor background.
• Working knowledge of ICH GCP standards and FDA treatment‑use/expanded access processes.
• Strong organizational, analytical, and communication skills within a fast‑paced environment.