The Helen Diller Family Comprehensive Cancer Center (HDFCCC) is seeking a Clinical Research Coordinator (CRC) Supervisors / Protocol Project Manager for the Gastrointestinal Oncology Program. Under the supervision of the Clinical Research Manager (CRM), the CRC Supervisors / Protocol Project Manager is tasked with managing and facilitating the Gastrointestinal Oncology Program day-to-day operations of their direct reports. The CRC Supervisors / Protocol Project Manager reports to the Gastrointestinal Oncology Program Lead CRC.

Under their direction, the CRC Supervisors / Protocol Project Manager is responsible for training and supervising a team of three to six clinical research coordinators. The CRC Supervisors / Protocol Project Manager is responsible for training and evaluating CRC performance in executing studies, direct oversight of data collection and reporting, to accomplish implementation of protocols within the program that meet federal, state and institutional policies and guidelines.

The CRC Supervisors / Protocol Project Manager assists the CRM in resolving operational, workload, protocol implementation, and data collection issues. The candidate will be a proven team-player with project management skills and mindset and can consistently deliver results on a tight timeline. The CRC Supervisors / Protocol Project Manager will work with the CRM to develop standard operating procedures and is responsible for training and mentoring CRCs to coordinate studies per Good Clinical Practice, with the goal to achieve optimal efficiency and productivity without jeopardizing patient care and data integrity. The individual will be a team player and assist with projects, patient coverage.

In addition to supervising clinical research coordinators, the CRC Supervisors / Protocol Project Manager will serve as the main point of contact between the Principal Investigator (PI) and Sponsor during study activation and maintenance.

Specific duties related to study activation may include completing pre-activation tasks such as feasibility surveys and assessment with study team; coordinating protocol reviews and submissions to Disease Site Committee and Protocol Review Committee; identifying ancillary committee approval with study team required by a protocol and initiate the process for review, and timely processing of new protocols through the activation pipeline including Medicare coverage analysis and budget sign off, informed consent approval and Institutional Review Board (IRB) submission, contract execution, and billing set up.

Other duties may include, but will not be limited to facilitate start-up and study coordination at external sites for multi-site investigator initiated studies; supervise and manage the following: the tasks of single or multiple clinical research studies; coordinating study start-up; act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; train CRCs, oversee study data integrity.

Department Overview:

The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is one of only two cancer centers in the Bay Area to receive the prestigious designation of “comprehensive” from the National Cancer Institute (NCI). The HDFCCC integrates the work of researchers and clinicians dedicated to four fundamental pursuits: laboratory research into the causes of cancer progression; clinical research to translate new knowledge into viable treatments; compassionate, state-of-the-art patient care; and population research that can lead to improvements in prevention, early detection, and quality-of-life for those living with cancer. The twin pillars of precision medicine and precision population health guide research and treatment at HDFCCC.

Minimum Required:

• Bachelor's degree in related area.
• Clinical Trial Professional certification from a professional society within one year in position.
• Minimum of 1 year Lead/Supervisory/Manager experience.
• Minimum of 3 years of related experience.
• At least one year of experience in project/program coordination, preferably in clinical trials, either at UCSF or at another academic or research institution.
• Working knowledge of clinical or laboratory research, clinical trial recruitment, eligibility, protocol adherence, quality data submission and adverse event reporting.
• Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.
• Demonstrated skills in employee supervision and HR administration. Demonstrated experience in training others, particularly in the field of research.
• Critical thinking skills to evaluate issues and identify a potential solution.
• Clear and concise communicator; good verbal and written communication skills; both.
• Good interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration.
• Ability to perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus' clinical information and documentation application programs. Proven ability utilizing clinical trial management systems.
• Clinical Trial Professional certification from a professional society within one year in position.
• Knowledgeable in the IRB requirements as well as FDA regulations for human subject safety.
• Experience working with sensitive populations, preferably with oncology patients.
• Knowledge of medical/oncology process and terminology; experience and knowledge of IRB policy and procedure; background in science/medicine preferably in hematology/oncology.
• NCI/CTEP requirements of clinical trials programs, especially in terms of reporting adverse events.
• Ability to cultivate relationships with multiple stakeholders at various levels of administration
• Highly organized and have the ability to prioritize projects to meet the demands of a fast-paced and dynamic work environment.
Able to sit and work at a computer for up to 8 hours/day; stand/walk for 3-6 hours; bend/stoop for up to 3 hours; reach for up to 3 hours; repetitive use of upper extremities for up to 8 hours; able to lift and/or carry 25 pounds; able to hear alarms, clients and/or instructions. Ability to see accurately from 20 inches to 20 feet.

Preferred:

• Advanced degree preferred .
• At least 1 years experience with industry clinical trials as a CRC.
Experience and knowledge of medical care and Phase I-III clinical trials, preferably with oncology trials.

License / Certification:

• Clinical Trial Professional certification from a professional society within one year in position.