Job Summary The Protocol Project Manager (PPM) will work in the Hematopoietic Malignancies research program and serve as the main point of contact between the study team including faculty and clinical research coordinators (CRC), outside entities such as sponsors, and the Clinical Research Support Office (CRSO), which is a centralized service unit in the HDFCCC offering clinical trial management services. The candidate will be accountable for clinical trial study start up, maintenance and close out.
A successful applicant will thrive in a fast paced environment, take initiative, and resolve problems and provide clarity in ambiguous situations. We are looking for a go-getter with excellent relationship building skills, and a team player who can also work independently.
Duties Include: *Complete pre-activation tasks such as feasibility surveys and assessment with study team. *Coordinate protocol reviews and submissions to Disease Site Committee and Protocol Review Committee. *Identify ancillary committee approval with study team required by a protocol and initiate the process for review. *Assist PI with the development of concept sheets, investigational brochure or package insert for CRSO regulatory protocol editor for investigator initiated trials. *Ensure timely processing of new protocols through the activation pipeline including Medicare coverage analysis and budget sign off, informed consent approval and IRB submission, contract execution, and billing set up. *Ensure policies mandated by the HDFCCC, federal government, any outside entity and study team are followed during trial activation pipeline, maintenance phase and close-out. *Coordinate and prepare for sponsor or collaborator visits such as site initiation, audit and monitor visits. *Update clinical trial management databases. *Assist study team to develop contingency action plans. *Flexibility to adapt to changing circumstances. *Excellent organizational skills, multitasking and communication both written and spoken.The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is the only cancer center in the Bay Area to receive the prestigious designation of 'comprehensive' from the National Cancer Institute. We combine basic science, clinical research, epidemiology, cancer control and patient care throughout the University of California, San Francisco. Currently, the HDFCCC conducts over 700 clinical trials across various departments and is in process of expanding with our new BRCA Center and Immunotherapy Program.Required Qualifications * BS/BA degree in a related area and/or equivalent experience/training. Sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training. * Ability to obtain certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals within 1 year of date of hire * In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, Food & Drug Administration (FDA) regulations, and complex visit structures * Significant project and clinical trial management experience or progressively responsible experience in a related position including regulatory and compliance responsibilities * Working knowledge of Microsoft Office applications such as Word, PowerPoint, Project and Excel * Experience with clinical trials regulatory affairs, or related clinical trials experience such clinical research coordinator experience * Working knowledge of clinical trial design, clinical study operations, or regulatory approval process * Experience working with medical providers and personnel * Project management skills to oversee the administrative operations of the clinical trials program; knowledge of strategies for recruiting human subjects * Demonstrated ability to develop recruitment strategies in complex environments and differing patient pools, independently identifying recruitment leads, implementing new strategies, and continually adjusting strategies to meet current recruitment goals * Ability to assess and respond to audit risk; ability to develop project plans/schedules and motivate team to meet deadlines * Ability to interpret and apply policies and regulations * Ability to analyze complex and non-routine issues requiring innovative solutions * Ability to operate effectively in a changing organizational and technological environment * Exceptional analytical skills to evaluate the importance and urgency of problems; excellent demonstrated interpersonal, verbal and written communication skills * Demonstrated ability to work within a team environment with faculty and staff at all level
Note: Physical/health screening required.Preferred Qualifications * Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals * Fluency in spreadsheet software; ability to develop complex spreadsheets independently; demonstrated skills in audit preparation, execution, and follow-up * Experience in risk management regarding study subjects, federal and non-federal sponsors and regulating bodies * Experience with grant application procedures, personnel documentation, contract generation and subcontracting, preferably at the location * Experience with UCSF Helen Diller Family Comprehensive Cancer Center research process with the proven ability to both work independently and seek information from appropriate sources when needed in order to maintain human subject safety and data integrity * Excellent written and verbal communication skills * Experience with project management with a proven ability to work with UCSF Medical Center staff of differing professional levels * Experience within the Investigational Trials Resource department of the HDFCCC * Experience with Oncore and UCSF's electronic medical record system, ApexLicense/Certification * Ability to obtain certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals within 1 year of date of hireAbout 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.