Date Posted: 06/19/2026
Hiring Organization: Rose International
Position Number: 503081
Industry: Biotech/Healthcare
Job Title: Medical Affairs Associate
Job Location: Santa Monica, CA, USA, 90405
Work Model: Hybrid
Work Model Details: Hybrid in Santa Monica or El Segundo CA
Shift: Monday-Friday (first Shift)
Employment Type: Temporary
FT/PT: Full-Time
Estimated Duration (In months): 13
Min Hourly Rate($): 30.00
Max Hourly Rate($): 36.00
Must Have Skills/Attributes: GCP
Experience Desired: Oncology/hematology experience (1+ yrs); Study start-up experience from a prior site-based regulatory role, CRO role, or sponsor role (5+ yrs)
Required Minimum Education: Bachelor’s Degree
**C2C is not available**
Job Description
Education:
• Bachelors
Required Skills:
• BS/BA/RN in nursing, science, or a health-related field with 3-5 years of related experience.
Preferred Skills:
• Oncology/hematology experience preferred; cellular therapy experience is a plus.
• Experience with iMedidata/RAVE EDC is a plus.
• Study start-up experience from a prior site-based regulatory role, CRO role, or sponsor role is a plus.
• Ability to manage competing time demands, incomplete information, and unexpected events.
• Strong analytical and problem-solving skills.
• High attention to detail.
• Outstanding organizational skills with the ability to multitask and prioritize effectively.
• Excellent interpersonal, verbal, and written communication skills in a collaborative work environment.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities.
• Working knowledge of transplant patient care and apheresis collection is a plus.
Summary:
• This role supports Medical Affairs activities related to expanded access programs, out-of-specification case support, and single-patient IND processes.
• The individual contributes to the operational execution of treatment-use and clinical support activities by coordinating study- and program-related deliverables, managing vendors and external partners, supporting site and investigator communications, tracking key milestones and risks, and helping ensure activities are conducted in alignment with applicable regulations, internal procedures, and program requirements.
Responsibilities:
• May assist in the review of study-related and essential start-up documents, as delegated by the study manager, including clinical protocols, informed consent forms, investigator brochures, pharmacy manuals, monitoring plans, case report forms, CRF completion guidelines, and other relevant study plans and charters.
• With guidance, plays a direct role in clinical study and program execution by managing assigned components of studies or expanded access activities and serving as a member of the study team.
• Supports activities associated with out-of-specification programs, expanded access programs, and single-patient IND requests, including coordination of timelines, documentation, communications, and cross-functional follow-up.
• Manages vendors and works with multiple contract research organizations and external partners to communicate detailed timelines, oversee transferred obligations, and ensure performance expectations are met; provides corrective instruction as needed when expectations are not met.
• Attends internal team meetings and other required meetings to support program planning, issue resolution, and execution.
• Provides training, as needed, at investigator meetings and other trial- or program-specific meetings, such as site initiation visits and monthly teleconferences.
• Creates and reviews site feasibility assessments required for participation, where applicable.
• Manages and tracks key deliverables such as screening, enrollment, data flow, protocol deviations, and other program milestones.
• Proactively identifies potential study or program issues and risks, recommends and implements solutions, and escalates issues appropriately to senior management.
• Prepares metrics and status updates on key deliverables for management review.
• Assists in the resolution of clinical trial queries for interim analyses, primary analyses, and final database locks, as applicable.
• Prepares site newsletters and other correspondence related to clinical trial or program conduct, including best practices, lessons learned, and frequently asked questions, in collaboration with the study team.
• Assists in the resolution of routine questions from clinical trial sites and external stakeholders in adherence to ICH GCP, study protocols, and applicable treatment-use requirements.
• May participate in special projects and other duties as assigned.
• Applies standard medical and scientific terminology appropriately in support of documentation, communication, and operational execution.
- **Only those lawfully authorized to work in the designated country associated with the position will be considered.**
- **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**
Benefits:
For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.
California Pay Equity:
For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.
Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.
If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.
Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).
The interactions that I have had with your representatives have always been prompt and very professional. I am very pleased and impressed with your company and services.
Sioe, Consultant
Each time I contacted Rose, I was completely satisfied with the great attention and customer service I received. Each person was extremely knowledgeable and patient with my concerns or questions.
Diana, Consultant
I had a very positive experience working for Rose. The entire process is very efficient and easy.
Joanne, Consultant
I am very happy with the Rose International, and the professionalism of the employees.
Robin, Consultant
Working for Rose International was the most pleasant assignment I have ever had. They were always on top of situations when necessary, and very helpful. I was very proud to be an employee of Rose International, and would recommend anyone to try to work with them.
Melvon, Consultant
EMPLOYEE COMMENTS