Protocol Review and Monitoring System (PRMS) Manager
Protocol Review and Monitoring System (PRMS) Manager
Job Number: 76656
The Protocol Review and Monitoring System (PRMS) Manager is responsible for leading cancer-related clinical research oversight operations at the Stanford Cancer Institute (SCI), including the coordination and implementation of SCI's two clinical research oversight committees, the Scientific Review Committee (SRC), and the Data and Safety Monitoring Committee (DSMC), as well as managing SCI's Quality Assurance Program and the staff involved in all three operations. The PRMS Manager is responsible for oversight of regulatory compliance of clinical research on behalf of the SCI.
The PRMS Manager is responsible for designing, developing, and implementing tools, processes and strategies of a moderate to complex nature to ensure regulatory compliance, high quality clinical trial conduct, along with improvement plans and training necessary to achieve these goals. The PRMS Manager is responsible to ensure that each cancer center trial is reviewed using a risk-based approach for regulatory compliance, protocol adherence, safety, and good clinical practice. They also ensure safety issues are reviewed in a timely manner including the reporting of adverse reactions in compliance with local and government regulations, and the review of these adverse events by the DSMC as appropriate. In addition, they ensure that data collected on Stanford's cancer clinical trials is accurate, reliable, and verifiable; and that our trials remain in compliance with all institutional and federal regulations. The PRMS Manager ensures that the SRC reviews protocols before subjects are accrued, and then routinely for accrual and scientific progress, and continued scientific relevance, per National Cancer Institute (NCI) and SCI requirements. The PRMS Manager develops and manages a Quality Assurance Program for SCI. The Quality Program includes quality reviews of studies, staff and investigator education, and guideline and standard operating procedure development. The PRMS Manager's efforts contribute to continually improving the quality of conducting clinical trials in compliance with local, state and federal requirements, along with meeting NCI requirements for PRMS activities in accordance with the Cancer Center Support Grant (CCSG).
The PRMS Manager interacts directly with SCI leadership including the SCI Director, SCI Associate Director of Clinical Research, Executive Administrative Director of CCTO and the Director of the Clinical Research Oversight Group. They are responsible for working with SCI leadership to develop and implement continuous quality improvement strategies, documentation, and training for staff and investigators. They author communications that may be sent to cancer center administration and investigators along with any other relevant organizations such as the Cancer Clinical Trials Office, and the Stanford Institutional Review Board and external agencies.
The PRMS manager hires, orients, and provides ongoing training and direct supervision to PRMS and Quality Assurance staff members. The PRMS manager oversees audits of all SCI trials based upon risk and DSMC standard operating procedures, and supervise the SCI staff when they serve as auditors.
The PRMS Manager oversees preparation for and execution of SRC and DSMC Committee Meetings, and DSMC Audits. The PRMS Manager ensures that SRC reviews are completed in a timely manner, and that the SRC SOPs are followed, including the completion and tracking of follow-up activities and communications. For DSMC audits, they determine the appropriate auditing team participants for the study, manage the team efforts, oversee the regulatory review, participate as an auditor as needed, and prepare the resulting reports.
The PRMS Manager maintains an organizational and operational structure for tracking a large amount of information. The number of cancer studies to be reviewed and tracked is expected to be approximately 250 studies annually. The PRMS Manager is charged with identifying opportunities to increase efficiency in PRMS operations. NCI and other regulatory standards are continually changing. This position requires a strong knowledge of federal, state and local regulations regarding the conduct of clinical trials and the protection of human research subjects. The PRMS Manager provides guidance to Investigators to help ensure that the additional responsibilities of holding an IND/IDE are being met. The PRMS Manager must employ technical knowledge of Cancer Institute clinical research and standard operating procedures in order to assure that the PRMS operates efficiently and is compliant with local and government requirements.
The PRMS Manager has excellent organizational skills and superb attention to detail; strong communication and interpersonal skills as information is communicated in electronic, written, and verbal communications to principal investigators, medical and research personnel; and strong management and supervisory skills.
* - Other duties may also be assigned. DESIRED QUALIFICATIONS:
- Experience developing, implementing and evaluating an educational program
- Knowledge of NCI Cancer Center Support Grant clinical research components
- Regulatory or clinical research certification
Bachelor's degree and five years of related experience including two years of supervisory experience or a combination of relevant education and experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Experience in clinical research management and oversight, including project management in a dynamic research setting.
- Experience in a lead role and interactions with federal agencies, i.e. FDA.
- Expert knowledge of regulatory affairs, including IRB review and approval process and Good Clinical Practice.
- Knowledge of International Conference on Harmonization (ICH) standards.
- Experience in developing and implementing multifaceted projects.
- Excellent communication and organizational skills and superb attention to detail.
- Experience with MS Office products and database applications required.
- Strong written and verbal skills.
- Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds.
- Occasionally sit, use a telephone or write by hand.
- Rarely kneel, crawl, climb, twist, bend, stoop, squat, reach or work above shoulders, sort, file paperwork or parts, operate foot and hand controls.
May require occasional local and overnight travel.
WORK STANDARDS (from JDL):
- Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
- Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
- Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.
Location: School of Medicine
To be considered for this position please visit our web site and apply on line at the following link: stanfordcareers.stanford.edu
Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.