Protocol Project Coordinator

Protocol Project Coordinator HDF Comprehensive Cancer Ctr Full Time 80513BR Job Summary The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is a national leader in oncology research. The HDFCCC clinical research program is a fast paced program with a broad portfolio of clinical trials. The mission of the UCSF HDFCCC clinical research program is to provide patients and their families with streamlined access to cutting-edge cancer therapies in addition to providing compassionate, patient-centered care. Our team of clinicians and researchers is dedicated to improving outcomes for all patients.The Pediatric Oncology program is seeking a Protocol Project Coordinator with an interest in providing regulatory support to our growing program.Under the general direction of the Program Leaders, the Protocol Project Coordinator will provide regulatory administration, project management, and administrative support for the Pediatric Oncology Research Department at the University of California San Francisco. The incumbent's responsibilities will include: interfacing with Program Investigators and study sponsors, administrative support of clinical trials, regulatory maintenance, and IRB submission tasks for clinical trial protocols.Incumbent's duties may include, but will not be limited to, assisting with the regulatory aspects of multiple clinical research studies (sponsored, cooperative group, and investigator-initiated studies),help assure compliance with all relevant regulatory agencies implement and maintain periodic quality control procedures; ensure policies mandated by the HDFCCC, federal government, any outside entity and study team are followed during trial maintenance phase and close-out, coordinate and prepare for sponsor or collaborator visits such as site initiation, audit and monitor visits, interface with departments to assist with obtaining UCSF approval prior to study initiation; maintain relevant regulatory documents; report study progress to investigators and sponsors, update clinical trial management databases, and perform other duties as assigned.The final salary and offer components are subject to additional approvals based on UC policy.Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement.The salary range for this position is $34.32 - $55.19 (Hourly Rate).To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html Department Description The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is a national leader in oncology research. The HDFCCC clinical research program is a fast paced program with a broad portfolio of clinical trials. The mission of the UCSF HDFCCC clinical research program is to provide patients and their families with streamlined access to cutting-edge cancer therapies in addition to providing compassionate, patient-centered care. Our team of clinicians and researchers is dedicated to improving outcomes for all patients. Required Qualifications HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with working with prestigious Pediatric Oncologists. Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.Ability to relate effectively in person and via telephone and email with physicians, nurses, data managers, as well as medical records and information science departmentsDemonstrated knowledge and understanding of research, especially in the areas of biological sciences.team members, other departments and outside institutions; and the ability to multi-task in a fast-paced environment while.Prior experience with various computer programs (Microsoft Office; internet-based databases).Ability to sit and work at a computer for up to 8 hours per day. May need to travel between one or more campuses via UCSF shuttle. Ability to stand for several hours of the day. Ability to independently interpret and apply policies, respond to requests, resolve issues, and provide assistance to faculty and staff at all levels in a team-oriented environmentAbility to work with a sensitive population of patients (oncology patients) Strong organizational skills.Ability to operate effectively in a changing organizational and technological environment. Preferred Qualifications B.A. or B.S with a major in science or relatedPrior analytical and writing skills in a science/research environmentExperience with clinical trials regulatory affairs, or related clinical trials experience such clinical research coordinator experience.Knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, andcomplex visit structures.Working knowledge of clinical trial design, clinical study operations, or regulatory approval process.Demonstrated ability to work within a team environment with faculty and staff at all levels.Experience working with medical providers and personnel.Experience with oncology clinical trials, or related therapies in drug clinical trials.Exposure to, or on the job use of, medical terminology.Experience preparing submissions for IRB, IND safety reporting, or continuing reviews.Experience with clinical trials management software such as OnCore.Experience applying the following regulations and guidelines:Good Clinical Practice GuidelinesHealth Information and Accountability Act (HIPAA)The Protection of Human Research SubjectsIRB regulations for recruitment and consent of research subjectsEnvironmental Health and Safety Training About UCSF The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. We bring together the world's leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells. Pride Values UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence - also known as our PRIDE values. In addition to our PRIDE values, UCSF is committed to equity - both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available at diversity.ucsf.edu Join us to find a rewarding career contributing to improving healthcare worldwide. Equal Employment Opportunity The University of California San Francisco is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Organization Campus Job Code and Payroll Title 009335 CLIN RSCH CRD Job Category Research and Scientific Bargaining Unit University Professional Technical Employees - Research Support Professionals Unit (UPTE-RX) Employee Class Career Percentage 100% Location Hybrid, Mission Bay (SF) Shift Days Shift Length 8 Hours Additional Shift Details Monday - Friday #J-18808-Ljbffr