Job Description
Job Description
ATR International is hiring a Medical Affairs II Contractor for a major client!
Location: Santa Monica, CA
Hourly Rate: $36.00
Key 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.
Basic Qualifications
- BS/BA/RN in nursing, science, or a health-related field with 3-5 years of related experience.
Preferred Qualifications
- 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.
Benefits
Full-time employees (working an average of 30 hours or more) are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, a 401(k) retirement savings plan with employer match (available after 1 year of employment), commuter benefits, employee discount and referral programs, and life and supplemental income insurance. Paid sick leave is provided in accordance with applicable state and local laws.
Compensation
Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience, as well as the benefits package you select.
Work Authorization
ATR International, Inc. cannot sponsor work visas (H-1B, F-1 STEM OPT with I-983, or similar). Candidates must have valid U.S. work authorization.
ATR International, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Company DescriptionATR International is a staffing and workforce solutions firm providing high‐quality talent across a wide range of industries, including technology, operations, and professional services.
Company Description
ATR International is a staffing and workforce solutions firm providing high‐quality talent across a wide range of industries, including technology, operations, and professional services.