Clinical Trial Management Associate (San Francisco, CA)Summary: The Clinical Trial Associate supports clinical trial operations by coordinating participant screening and enrollment, managing biospecimen collection, and collaborating with site staff, vendors, and technical teams. This role upholds regulatory and compliance standards, maintains accurate trial documentation, and provides essential updates and training to CROs and investigative sites. The Clinical Trial Associate is pivotal in maintaining study quality and proactively addressing potential risks within a dynamic, fast-paced environment.
Key Responsibilities: Act as the primary liaison for participant screening and enrollment, coordinating closely with site research staff, vendors, and technical operations.Schedule and manage the "cell journey" process, including treatment initiation, patient visits, and biospecimen collection per protocol.Ensure regulatory compliance in clinical sample collection, including adherence to HIPAA, privacy policies, and chain-of-custody standards.Review and maintain consent form language across protocols to ensure consistency with biospecimen and investigational product storage policies.Maintain the electronic trial master file (eTMF), conducting regular cross-functional reviews for accuracy and completeness.Develop and deliver training materials for CROs and investigative sites.Prepare metrics and management updates, identifying and resolving study issues proactively.Oversee CROs and vendors, ensuring adherence to timelines and performance expectations.Support the development, review, and implementation of SOPs and study-specific processes.Assist in other studies and provide cross-functional support as required.Qualifications: BS/BA in nursing, science, or a health-related field with 2+ years of oncology clinical trial management experience.Familiarity with transplant patient care and apheresis collection is beneficial.Experience in CRO/vendor oversight preferred.Strong understanding of clinical research and trial methodology.Willingness to travel to clinical sites and the South San Francisco office as needed.Ability to handle time constraints, incomplete information, and unexpected events effectively.Strong analytical, problem-solving, and organizational skills, with attention to detail.Excellent interpersonal, verbal, and written communication skills suited to a matrixed team environment.Ability to adapt to new technologies and approaches creatively and innovatively.Comfortable working in a fast-paced, small-company environment with shifting priorities.Department: Direct Clients
This is a full-time position.
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