University of California - San Francisco Campus and Health
Clinical Research Supervisor - Gastrointestinal Oncology Program
University of California - San Francisco Campus and Health, San Francisco, California, United States, 94199
Clinical Research Supervisor - Gastrointestinal Oncology Program
Helen Diller Family Comprehensive Cancer Center
Full Time
80170BR
Job SummaryThe 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, in order 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 have the ability to 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, and other CRC duties whenever necessary.
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; supporting the management and coordinating 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.
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 $86,300 - $130,900 (Annual Rate).
Department DescriptionThe 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.
Required Qualifications
Bachelor's degree in related area and / or equivalent experience / training.
3+ years related experience
1+ years of lead/supervisory/management experience
Clinical Trial Professional certification from a professional society within one year in position.
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.
Good interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship.
Ability to perform all commonly applicable functions in word processing and spreadsheet software. Proven ability utilizing clinical trial management systems.
Highly organized and have the ability to prioritize projects to meet the demands of a fast-paced and dynamic work environment.
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.
Prior experience with various computer programs, like Microsoft Office, and clinical trial management systems.
At least one year of experience in project/program coordination, preferably in clinical trials, either at UCSF or at another academic or research institution.
Knowledgeable in the IRB requirements as well as FDA regulations for human subject safety.
Supervisory experience or demonstrated experience in training others, particularly in the field of research.
Experience working with sensitive populations, preferably with oncology patients.
Ability to cultivate relationships with multiple stakeholders at various levels of administration.
Have excellent interpersonal skills, including but not limited to: communication, problem-solving, teamwork development, leadership, mentorship.
Preferred Qualifications
Advanced degree preferred.
Must possess a solution-oriented attitude and be adaptable to quickly changing priorities.
Certification as a clinical trial professional from one of the professional societies, such as ACRP or SoCRA and has attended any of their seminars.
Prior experience in clinical research in various areas of oncology, particularly in medical oncology, lab based research.
Prior experience with UCSF, particularly with research in the oncology setting, clinical trial billing, and institutional policies for study compliance and regulation.
Prior experience working with OnCore, EPIC (APEX), and other data management systems.
About UCSFThe 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.
Pride ValuesUCSF 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.
Equal Employment OpportunityThe 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.
OrganizationCampus
Job Code and Payroll Title009548 CLIN RSCH SUPV 1
Job CategoryProfessional and Managerial, Research and Scientific
Bargaining Unit99 - Policy-Covered (No Bargaining Unit)
Employee ClassCareer
Percentage100%
LocationFlexible (combination of onsite and remote work), Mission Bay (SF)
ShiftDays
Shift Length8 Hours
Additional Shift DetailsMonday - Friday; 40 hours/week
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Helen Diller Family Comprehensive Cancer Center
Full Time
80170BR
Job SummaryThe 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, in order 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 have the ability to 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, and other CRC duties whenever necessary.
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; supporting the management and coordinating 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.
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 $86,300 - $130,900 (Annual Rate).
Department DescriptionThe 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.
Required Qualifications
Bachelor's degree in related area and / or equivalent experience / training.
3+ years related experience
1+ years of lead/supervisory/management experience
Clinical Trial Professional certification from a professional society within one year in position.
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.
Good interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship.
Ability to perform all commonly applicable functions in word processing and spreadsheet software. Proven ability utilizing clinical trial management systems.
Highly organized and have the ability to prioritize projects to meet the demands of a fast-paced and dynamic work environment.
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.
Prior experience with various computer programs, like Microsoft Office, and clinical trial management systems.
At least one year of experience in project/program coordination, preferably in clinical trials, either at UCSF or at another academic or research institution.
Knowledgeable in the IRB requirements as well as FDA regulations for human subject safety.
Supervisory experience or demonstrated experience in training others, particularly in the field of research.
Experience working with sensitive populations, preferably with oncology patients.
Ability to cultivate relationships with multiple stakeholders at various levels of administration.
Have excellent interpersonal skills, including but not limited to: communication, problem-solving, teamwork development, leadership, mentorship.
Preferred Qualifications
Advanced degree preferred.
Must possess a solution-oriented attitude and be adaptable to quickly changing priorities.
Certification as a clinical trial professional from one of the professional societies, such as ACRP or SoCRA and has attended any of their seminars.
Prior experience in clinical research in various areas of oncology, particularly in medical oncology, lab based research.
Prior experience with UCSF, particularly with research in the oncology setting, clinical trial billing, and institutional policies for study compliance and regulation.
Prior experience working with OnCore, EPIC (APEX), and other data management systems.
About UCSFThe 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.
Pride ValuesUCSF 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.
Equal Employment OpportunityThe 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.
OrganizationCampus
Job Code and Payroll Title009548 CLIN RSCH SUPV 1
Job CategoryProfessional and Managerial, Research and Scientific
Bargaining Unit99 - Policy-Covered (No Bargaining Unit)
Employee ClassCareer
Percentage100%
LocationFlexible (combination of onsite and remote work), Mission Bay (SF)
ShiftDays
Shift Length8 Hours
Additional Shift DetailsMonday - Friday; 40 hours/week
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