OVERVIEW
We are currently seeking a highly organized and collaborative Medical Affairs Associate to join a well-known client’s team in Santa Monica, CA. This role supports Medical Affairs operations related to expanded access programs, out-of-specification case support, and single-patient IND processes.
The Medical Affairs Associate will contribute to the execution of clinical and treatment use programs by coordinating deliverables, managing vendors, supporting site communications, and tracking critical milestones. This position offers the opportunity to work at the intersection of clinical operations and medical affairs, supporting programs that expand patient access to investigational therapies.
RESPONSIBILITIES
Clinical & Program Execution
• Support execution of expanded access programs, out-of-specification cases, and single-patient IND requests.
• Coordinate timelines, documentation, and cross-functional deliverables for assigned programs.
• Assist in review of study-related documentation including protocols, informed consent forms, investigator brochures, CRFs, monitoring plans, and study charters.
• Participate as a member of study teams, supporting operational activities across program lifecycles.
Vendor & Site Management
• Manage relationships with CROs, vendors, and external partners, ensuring alignment with timelines and deliverables.
• Provide oversight of vendor performance and communicate expectations; escalate and resolve issues as needed.
• Support site feasibility assessments and site onboarding activities.
• Assist in site communication, addressing routine inquiries in compliance with protocols and regulations.
Tracking, Reporting & Documentation
• Track key milestones including screening, enrollment, protocol deviations, and data flow.
• Prepare status updates, metrics, and reports for leadership review.
• Support resolution of clinical trial queries related to analyses and database activities.
• Prepare site communications, newsletters, and educational materials.
• Maintain accurate documentation and ensure compliance with ICH GCP and regulatory requirements.
Collaboration & Communication
• Attend internal and external meetings to support program planning and execution.
• Provide training support for investigator meetings, site initiation visits, and program-related sessions.
• Proactively identify risks, recommend solutions, and escalate issues to management as needed.
• Apply medical and scientific terminology appropriately in all communications and documentation.
EXPERIENCE
• 3–5 years of relevant experience in clinical operations, medical affairs, or a related field.
• Experience supporting clinical trials, expanded access programs, or treatment use protocols preferred.
• Experience working with CROs, vendors, and cross-functional teams.
• Familiarity with clinical systems such as iMedidata/RAVE EDC is a plus.
• Experience in study start-up activities (site or sponsor side) preferred.
Preferred:
• Experience in oncology/hematology or cellular therapy.
• Knowledge of transplant patient care or apheresis collection.
EDUCATION
• Bachelor’s degree in a scientific or health-related field (or RN equivalent) required.
TO BE A BEST FIT, YOUR STRENGTHS MUST INCLUDE
• Strong organizational skills with the ability to manage multiple priorities and deadlines.
• Excellent attention to detail and commitment to accuracy and compliance.
• Strong analytical and problem-solving skills.
• Effective communication skills, both written and verbal, in a collaborative environment.
• Ability to work independently in a fast-paced, dynamic setting with minimal supervision.
• Strong interpersonal skills with the ability to engage cross-functional teams and external stakeholders.
• Flexibility and adaptability in managing changing priorities and evolving program needs.
Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.
At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact accommodationrequest@advancedgroup.com.
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