Company: University of California, San Francisco
Position Title: Protocol Project Coordinator – Genitourinary Oncology Program
Department: Helen Diller Family Comprehensive Cancer Center
Location: Mission Bay
Position Type: Full Time
Percentage: 100%
Work Days/Shift: Monday – Friday, 8am – 5pm
Requisition #: 74931BR
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 Genitourinary 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 Genitourinary 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-ou, 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.
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 team members, other departments and outside institutions; and the ability to multi-task in a fast-paced environment while 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 departments
- Demonstrated knowledge and understanding of research, especially in the areas of biological sciences.
- 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 environment
- Ability to work with a sensitive population of patients (oncology patients)
- Strong organizational skillsAbility to operate effectively in a changing organizational and technological environment.
Preferred Qualifications:
- B.A. or B.S with a major in science or related
- Prior analytical and writing skills in a science/research environment
- Experience 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, and complex 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 Guidelines
- Health Information and Accountability Act (HIPAA)
- The Protection of Human Research Subjects
- IRB regulations for recruitment and consent of research subjects
- Environmental Health and Safety Training
About UCSF
In order to be considered for open positions at UCSF, you will need to submit your resume through our online application process. Once you complete the online application process, you will receive an email confirming that your submission has been received. Submitting your resume to UCSF opens the door to many immediate and ongoing job opportunities. Your resume will remain active in our applicant database and you will be able to update it as needed.
To submit your resume online go to: https://jobs.brassring.com/TGnewUI/Search/home/HomeWithPreLoad?PageType=JobDetails&partnerid=6495&siteid=5861&Areq=74931BR
Emailed applications are not accepted.
Apply specifically to requisition # 74931BR.
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.