The Helen Diller Family Comprehensive Cancer Center (HDFCCC) Oncology Investigational Trials Resource (ITR) Research Programs have experienced unprecedented growth, increasing its number of clinical visits, clinical research staff, protocols, and protocol enrollments. Cancer programs annually enroll over 120 patients in clinical trials, and partly as a result of this unsurpassed accrual rate, the site CRCs require strong internal group organization. In order to sustain this accrual without compromising quality of research, the Program will need a Lead Clinical Research Coordinator, Supervisor (CRC II) to assist in the execution of research enrollment, protocol adherence, and data management.
The Lead Clinical Research Coordinator-Supervisor reports to the Director of the Oncology Clinical Trials Research Group in Early Phase, Mt. Zion and the ITR Manager of the Research Personnel Office of the HDFCC. Under their direction, the Lead CRC is responsible for hiring, supervising, and organization of a team of 10-12 clinical research coordinators (CRC I) and 1-2 senior clinical research coordinators (CRC II) which includes assessing workload, assignments and oversight of data collection and clinical trial management in order to accomplish implementation of protocols within the program that meet federal, state and institutional policies and guidelines. The Lead CRC acts as advisor ensuring that proper training competencies have been accomplished and that overall workload can be managed safely and accurately. The Lead CRC advises the Director and Research Personnel Manager of all resource allocation and data management issues by facilitating effective, timely reporting, either at weekly scheduled protocol review meetings or one-on-one meetings.
The Lead CRC is responsible for coordinating new hire training with the HDFCCC CRC Research Personnel Office which oversees the on-the-job mentoring and training of new CRCs to their group. The Lead CRC will work with the Research Personnel Manager and Education & Training Coordinator to create new systems (documents and procedures), utilize the CTMS database and manage the CRCs with the goal to a more efficient and productive team. The incumbent will collaborate with the Education & Training Coordinator in the day-to day training and assure that CRCs utilize the system consistently, manage time appropriately and collect data in a timely manner according to GCP’s. The incumbent will be a team player and as needed assist with projects, patient coverage, and other CRC duties whenever necessary. The incumbent will also perform other duties as assigned.
• BA/BS, preferably in science, and three years related experience in administrative analysis or operations research; or an equivalent combination of education and experience;
• Experience interacting with oncology patients.
• NCI/CTEP requirements of clinical trials programs, especially in terms of reporting adverse events.
• Prior experience with various computer programs, like Microsoft Office, and clinical trial management systems.
• Two or Three years’ experience managing clinical trials either at UCSF or at another company/institution; knowledgeable in the CHR or other IRB requirements as well as FDA regulations for human subject safety.
• Supervisory experience.
• Experience and knowledge in oncology medical care and oncology Phase I/II clinical trials.
• Highly organized and have the ability to prioritize projects to meet the demands of a fast-paced and dynamic work environment.
• In depth knowledge of clinical trial recruitment, eligibility, protocol adherence, quality data submission and adverse event reporting and all areas of GCPs.
• Knowledge of medical/oncology process and terminology; experience and knowledge of IRB policy and procedure; background in science/medicine preferably in hematology/oncology.
• Experience in developing SOPs.
Physical Demands: requires sitting; standing; walking; squatting; bending; waist twisting; kneeling; climbing stairs; climbing ladders; reaching up to shoulder height; reaching above shoulder level; carrying/lifting 31-60 pounds; pushing/pulling up to 60 pounds; gripping/grasping, fine/gross finger manipulation; repetitive movements of upper and lower extremities; may be exposed to loud noises; dust, fumes or gases; chemical agents; tuberculosis, blood, body fluids or tissue, and radiological materials; latex, differentiate color; use protective equipment.
Note: Fingerprinting and background check required.
• Master’s degree in science.
• Completion of an educational program in clinical trial management which offers a certification.
• Certification as a clinical trial professional from one of the professional societies, such as ACRP or SoCRA and has attended any of their seminars.
• Two or Three years’ experience with industry clinical trials as a CRA.
• Prior experience with UCSF clinical trial billing.