Medical Affairs Associate

Unicon Pharma Inc; Santa Monica (CA); Remote; USD 90,000 - 140,000; Full time

Job summary

Unicon Pharma Inc. is seeking an experienced Medical Affairs Associate to support Medical Affairs and Clinical Operations activities, including Expanded Access Programs, OOS case support, and Single-Patient IND processes.

This is a fully remote role with collaboration across study teams. The position requires 3–5 years in Clinical Operations, strong organizational and analytical skills, familiarity with CTMS/EDC/RDMS, and a background in Nursing or Life Sciences.

Qualifications

• Bachelor's degree in Nursing, Life Sciences, or related healthcare field.
• 3–5 years of Clinical Operations experience.
• Prior experience managing or supporting clinical trials.
• Familiarity with clinical systems such as CTMS, EDC, and RDMS.
• Strong organizational, analytical, communication, and problem-solving skills.
• Cellular therapy experience.
• Experience with iMedidata/RAVE EDC.
• Study start-up experience in CRO, sponsor, or site-based regulatory environment.
• Knowledge of transplant patient care and apheresis collection.

Responsibilities

• Support clinical trials from study start-up through closeout.
• Coordinate Expanded Access Programs, OOS programs, and Single-Patient IND activities.
• Manage CROs, vendors, external partners, and study-related deliverables.
• Support review of essential study documents, including protocols, ICFs, IBs, and monitoring plans.
• Track study milestones, enrollment, data flow, risks, and protocol deviations.
• Coordinate site and investigator communications and resolve routine study-related queries.
• Prepare program metrics, status reports, and management updates.
• Ensure compliance with ICH-GCP, applicable regulations, and internal procedures.

Skills

Organizational skills

Analytical skills

Communication skills

Problem solving

Cross-functional work

Education

Bachelor's degree in Nursing/Life Sciences or related

Tools

CTMS

EDC (iMedidata/RAVE)

RDMS

Job description

Work Arrangement: Fully Remote

We are looking for an experienced Medical Affairs Associate to support Medical Affairs and Clinical Operations activities, including Expanded Access Programs, Out-of-Specification (OOS) case support, and Single-Patient IND processes.

This is an exciting opportunity for a clinical operations professional with experience in clinical trial management, vendor coordination, study execution, and cross-functional collaboration.

• Support clinical trials from study start-up through closeout.
• Coordinate Expanded Access Programs, OOS programs, and Single-Patient IND activities.
• Manage CROs, vendors, external partners, and study-related deliverables.
• Support review of essential study documents, including protocols, ICFs, IBs, and monitoring plans.
• Track study milestones, enrollment, data flow, risks, and protocol deviations.
• Coordinate site and investigator communications and resolve routine study-related queries.
• Prepare program metrics, status reports, and management updates.
• Ensure compliance with ICH-GCP, applicable regulations, and internal procedures.
• Bachelor's degree in Nursing, Life Sciences, or a related healthcare field.
• 3–5 years of relevant Clinical Operations experience.
• Prior experience managing or supporting clinical trials.
• Familiarity with clinical systems such as CTMS, EDC, and RDMS.
• Strong organizational, analytical, communication, and problem‑solving skills.
• Cellular therapy experience.
• Experience with iMedidata/RAVE EDC.
• Study start-up experience in a CRO, sponsor, or site-based regulatory environment.
• Knowledge of transplant patient care and apheresis collection.