What are the responsibilities and job description for the Clinical Operations Associate – Medical Affairs position at Unicon Pharma Inc?
About the Company
📍 Santa Monica / El Segundo, CA (Hybrid)
About the Role
We are seeking a Medical Affairs Associate to support Expanded Access Programs, Single-Patient IND requests, and clinical study operations. This role will coordinate cross-functional activities, manage study timelines and documentation, support investigator and site communications, oversee vendor deliverables, and help ensure compliance with regulatory and program requirements
Key Responsibilities
- Support Expanded Access Programs, Single-Patient INDs, and treatment-use activities.
- Coordinate study timelines, documentation, and stakeholder communications.
- Manage CROs, vendors, and external partners to ensure project milestones are met.
- Assist with study start-up activities, site feasibility assessments, and investigator support.
- Track study metrics, enrollment, protocol deviations, and key deliverables.
- Identify and escalate risks, issues, and operational challenges.
- Prepare status reports, newsletters, and program-related communications.
- Ensure activities are conducted in accordance with ICH-GCP, study protocols, and applicable regulations.
Qualifications
- BS/BA or RN in Life Sciences, Nursing, or a related healthcare field.
- 3–5 years of experience in Clinical Operations, Clinical Research, Medical Affairs Operations, or related functions.
- Experience supporting clinical studies, site management, or study start-up activities.
- Strong organizational, communication, and project coordination skills.
- Oncology/Hematology experience preferred; Cell Therapy experience is a plus.
- Experience with Medidata Rave/iMedidata EDC is a plus.
Preferred Backgrounds
Clinical Trial Associate (CTA), Clinical Research Associate (CRA), Clinical Operations Associate/Specialist, Clinical Study Associate, Medical Affairs Operations Associate, or Oncology Research Coordinator.