Supportive Care Services Clinical Research Coordinator

NeuSrg-General

Full Time

78763BR

Job Summary

The Supportive Care Services Clinical Research Coordinator will coordinate and be accountable for the overall administration of one or more clinical research studies, typically requiring advanced-level knowledge and skills.
The position is responsible for and critically important to the overall operational management of clinical research activities across the Supportive Care Services program within the Division of Neuro-Oncology. It has direct responsibility for implementing a diverse portfolio of research activities for one or more studies which may include multicenter clinical trials (both NIH and industry-sponsored), local investigator-initiated clinical trials, and/or programmatic clinical research activities, such as a clinical database and biorepository. Positions at this level may perform expert and efficient integration of multiple complex programmatic activities, applying a sophisticated medical knowledge base, substantial leadership skills, and effectively working with a variety of people and organizations at UCSF (clinicians, investigators, clinical staff, administration, Committee on Human Research, human resources, contracts, and grants) and elsewhere (industry sponsors, coordinating centers, FDA, NIH), exhibiting an in-depth knowledge of specific programs.
Reporting to the research manager, a Principal Investigator (PI), or Director, the incumbent may have central responsibility for subject recruitment, appropriate study testing, and adequate enrollment of clinical trials, longitudinal cohort studies, local investigator-initiated studies, and biorepository efforts; exercise strong administration and management skills of clinical research, strong research coordination, and ensure optimal systems for efficiency, compliance, safety, financial oversight, as well as work with stakeholders to create and implement quality improvement processes. This is a position whose main purpose is to ensure that clinical research commitments are met and that the programs maintain a reputation for excellence in all activities.

The final salary and offer components are subject to additional approvals based on UC policy.

To see the salary range for this position (we recommend that you make a note of the job code and use that to look up): TCS Non-Academic Titles Search (https://tcs.ucop.edu/non-academic-titles)

Please note: An offer will take into consideration the experience of the final candidate AND the current salary level of individuals working at UCSF in a similar role.

For roles covered by a bargaining unit agreement, there will be specific rules about where a new hire would be placed on the range.

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 Supportive Care Services (SCS) within the Division of Neuro-Oncology in the Department of Neurosurgery is a referral, recommendation, and treatment service for adult patients with Central Nervous System tumors (primary brain tumors) aimed at providing support to patients, caregivers, and their families. The Division of Neuro-Oncology Clinical Trials Program is an active research program that includes studies supported by pharmaceutical industry; investigator-initiated studies in collaboration with outside universities; NCI-cooperative groups. The SCS includes the Gordan Murray Caregiver Program, Sheri Sobrato Brisson Brain Cancer Survivor Program, Neurocognitive Clinic/Loglio Cognitive Project 5, integrated work with the Symptom Management Service (Palliative Care) Division at UCSF, and potential future projects within the Program.
Under the supervision of the Research Manager, the incumbent will collect and analyze protocol patient data for the management of clinical trials and program registries/databases run through the SCS within Division of Neuro-Oncology. The CRC will be responsible for managing patients on 1-5 active studies and up to 3 studies in follow-up, depending on the complexity of the patients, procedures, and other duties required.
Duties will include:

1. Interacting with patients and caregivers for recruiting, consenting, enrolling, and following patients through clinical procedures on clinical trials
2. Abstracting information from the medical record including medical history, prior treatment, vital signs, and other trial-related requirements;
3. Managing and assist in developing databases relevant to research studies
4. Assuring that laboratory work, imaging, neuropsychological and quality of life assessments, and other required procedures are carried out according to the protocol
5. Retrieving data/reports from computer systems as needed
6. Gathering lab results, MRI scans, and other information according to protocol-specific data requirements; Entering data onto protocol-specific case report forms (CRFs), study flow sheets, source documents, and other required study forms such as databases
7. Submitting timely and appropriate information on toxicities and adverse events
8. Obtaining, processing, and shipping serum and blood specimens according to protocol-specific data requirements
9. Maintaining accurate research charts and research study binders
10. Monitoring inventory of clinic and trial supplies and reordering when needed
11. Managing patient follow-up according to specific research study requirements
12. Assisting research manager in preparation for site visits and site audits
13. Performing initial quality control of forms prior to utilization
14. Assisting research manager with the processing and implementation of protocol modifications, amendments, and revisions for submission to the Cancer Center, Committee on Human Research (CHR), and CTSI CRC (CCRC)
15. Responding to inquiries from professionals and potential research subjects regarding clinical neuro-oncology research questions.
16. Assistance as co-author with preparation for abstracts, manuscripts, progress reports, grants, and presentations associated with relevant research studies

The incumbent must assure that protocols are being followed in complete compliance with their guidelines and assure that data is collected and submitted in a timely manner.

Required Qualifications

• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
• 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.
• Protocol preparation requires a working knowledge of federal, state and local research regulations and guidelines; protocol development; current CHR practices and guidelines; medical terminology; and clinical practice methods.
• In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures.
• Project management skills to oversee the administrative operations of the clinical trials program; knowledge of strategies for recruiting human subjects.
• Exceptional analytical skills to evaluate the importance and urgency of problems; excellent demonstrated interpersonal, verbal and written communication skills.
• Ability to analyze complex and non-routine issues requiring innovative solutions.
• Ability to operate effectively in a changing organizational and technological environment.
• 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.
• Significant project and clinical trial management experience or progressively responsible experience in a related position including regulatory and compliance responsibilities.

Preferred Qualifications

• Bachelor's degree in related area and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities and/or equivalent experience/training.
• 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 programming language/coding and software such as JuMP, R, or Python
• Experience with grant application procedures, personnel documentation, contract generation and subcontracting, preferably at UCSF.
• Experience with administering and scoring neurocognitive assessments
• Ability to interpret and apply policies and regulations regarding Committee on Human Research
• Experience using database software, such as MS Access or FileMaker Pro.
• Experience in risk management regarding study subjects, federal and non-federal sponsors and regulating bodies.
• Experience in administering, recording, and scoring human cognitive and behavioral tasks in addition to health-related quality of life patient reported outcomes (PRO) measures.
• Prior experience with post activation coordination of research studies and managing several protocols.
• UCSF Clinical research experience. Experience with electronic IRB submissions (iMedRIS). Experience with UCSF Cancer Center (OnCore) patient tracking and data entry.
• Completion of UCSF Clinical Research Study Coordinator 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

Parnassus Heights (SF)

Shift

Days

Shift Length

8 Hours

Additional Shift Details

M-F, 8am-5pm