Protocol Project Coordinator

$71,386 - $114,795/Yr

Ucsf Medical Center - San Francisco, CA

Full-time - Entry Level

San Francisco, CA

Hospitals

About the position

The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is a national leader in oncology research, and its clinical research program is known for its fast-paced environment and broad portfolio of clinical trials. The mission of the HDFCCC clinical research program is to provide patients and their families with streamlined access to cutting-edge cancer therapies while ensuring compassionate, patient-centered care. The team of clinicians and researchers at HDFCCC is dedicated to improving outcomes for all patients, making it a vital part of the oncology research landscape. The Pediatric Oncology program is currently seeking a Protocol Project Coordinator who is interested in providing regulatory support to this growing program. Under the general direction of the Program Leaders, the Protocol Project Coordinator will be responsible for regulatory administration, project management, and administrative support for the Pediatric Oncology Research Department at UCSF. This role involves interfacing with Program Investigators and study sponsors, providing administrative support for clinical trials, maintaining regulatory compliance, and managing IRB submission tasks for clinical trial protocols. The incumbent will assist with the regulatory aspects of multiple clinical research studies, which may include sponsored, cooperative group, and investigator-initiated studies. Key responsibilities include ensuring compliance with all relevant regulatory agencies, implementing and maintaining periodic quality control procedures, and ensuring that policies mandated by the HDFCCC, federal government, and study teams are followed during the trial maintenance phase and close-out. The Protocol Project Coordinator will also coordinate and prepare for sponsor or collaborator visits, maintain relevant regulatory documents, report study progress to investigators and sponsors, update clinical trial management databases, and perform other duties as assigned. This position is crucial for the successful execution of clinical trials and the overall mission of the HDFCCC.

Responsibilities

• Provide regulatory administration and project management support for the Pediatric Oncology Research Department.
• Interface with Program Investigators and study sponsors to facilitate clinical trials.
• Assist with the regulatory aspects of multiple clinical research studies, including compliance with regulatory agencies.
• Implement and maintain periodic quality control procedures for clinical trials.
• Ensure adherence to policies mandated by the HDFCCC and federal government during trial maintenance and close-out phases.
• Coordinate and prepare for sponsor or collaborator visits, including site initiation and audit visits.
• Maintain relevant regulatory documents and report study progress to investigators and sponsors.
• Update clinical trial management databases and perform other assigned duties.

Requirements

• High school graduation and sufficient experience to perform assigned duties and responsibilities.
• Attention to detail and strong interpersonal skills.
• Excellent verbal and written communication skills to coordinate with Pediatric Oncologists.
• Ability to work independently and prioritize multiple projects to meet deadlines.
• Ability to effectively communicate with physicians, nurses, and data managers.
• Demonstrated knowledge of research, particularly in biological sciences.
• Prior experience with various computer programs, including Microsoft Office and internet-based databases.
• Ability to sit and work at a computer for up to 8 hours per day and travel between campuses as needed.
• Strong organizational skills and ability to operate effectively in a changing environment.

Nice-to-haves

• B.A. or B.S. with a major in science or related field.
• Prior analytical and writing skills in a science/research environment.
• Experience with clinical trials regulatory affairs or related clinical trials experience.
• Knowledge of clinical research contracts, grants, and FDA regulations.
• Working knowledge of clinical trial design and regulatory approval processes.
• Experience working with medical providers and personnel in oncology clinical trials.
• Exposure to medical terminology and experience preparing submissions for IRB and IND safety reporting.
• Experience with clinical trials management software such as OnCore.

Benefits

• Comprehensive health insurance coverage
• Dental and vision insurance
• Retirement savings plan (401k)
• Paid holidays and vacation time
• Flexible scheduling options
• Tuition reimbursement for further education
• Professional development opportunities
• Employee wellness programs