Clinical Research Coordinator

JOB SUMMARY

The Clinical Research Coordinator (CRC) will provide research coordination for the UCSF ID Clinical Research Center (SF IDRC), within the HIV, Infectious Diseases and Global Medicine (HIVIDGM) Division. Our unit conducts new and ongoing clinical trials focused on several infectious diseases, including HIV, COVID-19, viral hepatitis, sexually transmitted infections and monkeypox. In this role, the coordinator will help screen, enroll, assist with all aspects of study visits and follow-up, including data entry and coordination with the investigational pharmacy.

The CRC will work at an independent level to assist the Principal Investigator, the study coordinator, and the study nursing staff with implementing study protocols, study coordination, data/specimen collection, data management, and quality assurance. The incumbent will recruit, screen, enroll, and follow study participants, and interact with health care providers, clinical researchers, collaborators, funders, and varied administrative and professional staff. This position will also help support outreach and recruitment efforts via social media and other venues.

This position help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; maintain all regulatory documents; report study progress to investigators; participate in any internal and external audits or reviews of study protocols; and perform other duties as assigned.

The CRC will have contact with potential or enrolled participants who are COVID suspects or have confirmed COVID or other viral/respiratory infections such as influenza or tuberculosis and will be given appropriate training on infection control and PPE use.

ABOUT DIVISION OF HIV, INFECTIOUS DISEASES AND GLOBAL MEDICINE

The Division of HIV, Infectious Diseases and Global Medicine at the University of California, San Francisco (UCSF) is an internationally recognized global leader in clinical care, research, and education. With its home-base located at Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG), the Division has been ranked as the top facility in the country for AIDS care since 1983. The Division's work is featured frequently in the media, and it is often visited by numerous international, national, state, and local dignitaries and delegations. The Division consists of approximately 36 faculty members, 11 fellows/postdoctoral scholars and 170 academic and staff employees. It is the largest Division of the Department of Medicine (DOM) at ZSFG, with a total expenditure budget of approximately $52 million dollars.

Responsibilities

of time

Essential Function (Yes/No )

Key Responsibilities

(To be completed by Supervisor)

55%

YES

Study Coordination and Data Collection

• Identify, interview, and (depending on type of study) consent participants, and assist clinical staff with study follow-up visits for 1-5 outpatient observational and/or treatment studies as assigned by the investigator and unit manager: Perform community outreach at appropriate sites in San Francisco and potentially in other locations in the Bay Area. Pre-screen potential participants (ask about current health conditions, medications, etc.) for clinical staff to be able to assess participant for advancement through the screening process. Assist with obtaining medical records (including from sources outside of university). Coordinate screening and on-study visits with nursing staff, assist with obtaining vital signs and collecting biological samples as necessary and within scope of practice/training. Administer questionnaires, train participants on proper data and specimen collection techniques where appropriate. Establish rapport with subjects, respond to their diverse needs, and become their intermediary between physicians and other departments (i.e. assist with care coordination).
• Communicate with Principal Investigator and/or unit manager regarding study and participant progress, notify unit leadership when problems or questions require a physician's involvement. Develop and maintain complex schedules for subjects enrolled in multiple studies. Develop and maintain complex schedules for participants enrolled in multiple studies. Develop, prepare and maintain study documents, subject files, and databases. Prepare complex laboratory setups and paperwork for specimen collection and tracking With training, perform centrifugation and aliquoting of blood and other biological samples or transport samples to processing laboratory for complex processing using IATA/Safe Shipping guidelines for biohazardous samples. Monitor collection of blood, STD self-swabs, rectal swabs, nasopharyngeal swabs, stool collection and aliquoting (when indicated) and ensure appropriate processing. Transport/ship specimens and paperwork to appropriate laboratories. Package and ship diagnostic specimens, coordinate complex shipping requests with multiple labs including using multiple carriers for both domestic and international shipments, and shipping samples in liquid nitrogen, maintain clinical supplies. Ensure all procedures, laboratory tests, and required data are collected at each visit; coordinate follow-up; and complete documentation.
• Coordinate care with primary provider and communicate regarding study participation, receipt of study provided medications, and any significant adverse events of which the provider/care team should be aware.
• Provide back-up coverage for other CRCs in implementing clinical research protocols nested within the research unit. Coordinate with teams to ensure correct specimens are collected according to protocol at the time of study procedures, which may include but are not limited to leukapheresis, electroporation, liver biopsy, gut biopsy, endoscopy, radiologic imaging, and lumbar puncture.
• Coordinate with the leukapheresis center(s) by confirming all protocol guidelines are met (providing signed consent, HIPAA and safety labs), as well as scheduling visits to establish sufficient venous access prior to scheduling procedure, arranging transport for the subject participants and couriers for specimen delivery to collaborating laboratories for analysis and storage.
• Facilitate histology processing of tissue samples from invasive biopsy procedures. Responsible for overseeing all aspects of the histology processing, including the safe and timely delivery of fixed tissue specimens to the histology lab, the subsequent cataloging of prepared slides and tissue blocks, and the distribution of necessary slides and tissue blocks to respective collaborating investigators.
• Work with UCSF accounting to ensure correct accounts are used for study-related charges and salary support. Review invoices and billing statements, provide accounting with study and funding information. Setup new laboratory accounts as needed.

20%

YES

Data Management and Reporting of Results

• Collect data during subject visits; enter data from visits into sponsor data capture (EDC) systems, procedures, lab tests, and other participants-related participation into databases in a timely manner.
• Coordinate with central data teams for sponsored projects as needed.
• Maintain data collection forms for effective data collection, entry, and analysis.
• Respond to queries and requests in databases.
• Work with unit manager to maintain complete and accurate data in the study database.

5%

YES

Staff Training

• Attend and actively participate in regular team meetings, including video conferences with other study sites, regular protocol meetings and occasional off-site team meeting.

5%

YES

Quality Control Procedures

• Oversee data integrity; initiate assessments of the adequacy of existing policies and procedures on subject recruitment, data collection, and data management.
• Update and maintain a procedure manual documenting all study-related procedures; help develop a plan to ensure consistency in data collection and data entry.
• Implement and maintain periodic quality control procedures

5%

YES

Regulatory Responsibilities

• Assure studies are carried out according to International Committee on Harmonization, Code of Federal Regulations, Good Clinical Practice, and UCSF regulations.
• Complete IRB reporting for continuing renewal, protocol modifications, and submit applications and protocols; ensure that protocol applications are submitted in a timely manner
• Assist regulatory analysts with maintenance of regulatory documents
• Use sound judgment to maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments.
• Participate in and cooperate with any internal and external audits or reviews of study protocols; prepare necessary documentation.

5%

YES

Financial Management

• Ensure billing is appropriate and accurate to avoid improper billing of Medicare, private insurance, or patients.
• Establish and maintain petty cash and/or Greenphire ClinCard as well as check requests for research participants stipends. Follow proper reimbursement procedures.

5%

YES
Other duties as assigned
100%
(To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.)

Qualifications

Required Qualifications:

• HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
• Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with participants, team members, other departments, and outside institutions and clinicians; and the ability to multi-task in a fast-paced environment while working with a diverse participant population.
• Ability to work well independently after training, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.
• Superior organizational skills, oral/written communication skills, attention to detail and accuracy.
• Responsible, motivated, efficient. Able to take initiative, prioritize, think critically, and meet deadlines. Comfortable working both independently and in a team setting.
  • Interpersonal skills necessary to interact effectively with a wide range of health professionals, administrators, and research subjects. Comfortable interviewing participants on sensitive issues including high risk sexual practices, sexually transmitted diseases, and substance use.
  • Able to carry boxes and supplies weighing up to 20-30 pounds, pack specimens into shipping containers, and deliver specimens to lab in a timely manner. Able to file heavy charts (up to 5 lbs.) in file cabinets.
  • Proficient in Microsoft Office programs with emphasis on Excel, Access, Word, Publisher. Savvy internet user and experience using smartphone applications.
• Demonstrate excellent attendance and reliability. Work during some evening hours and/or early morning hours required, possible weekend hours

Preferred Qualifications:

• BA/BS degree in related field
• Experience working with populations living with HIV and/or on HIV pre-exposure prophylaxis (PrEP) of other infectious agents. Knowledge of clinical research practices and longitudinal cohort studies. Minimum of two years' experience in clinical, community health setting and/or research setting.
• Minimum of two years' experience handling diagnostic specimens including safe handling and shipping practices
• Advertising/publishing experience to assist with developing outreach and recruitment strategies.
• Comfortable using social media platforms such as Instagram, Facebook and X (Twitter) for outreach and recruitment
• Fluency in the usage of UCSF IRB online IRIS system
• Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation.
• Experience working with culturally and linguistically diverse groups
• Experience with electronic medical records, with established access to EPIC.
• California Certified Phlebotomy Technician 1 (CPT-1)
• Familiarity with treatments for HIV-related infections, HIV pre-exposure prophylaxis, and medical terminology.
• Knowledgeable in biological sample collection techniques, including working knowledge of tubes and procedures required for blood draw of clinical laboratory tests, and sample processing for T-cell assays, flow cytometry, and other research assays
• Familiarity with basic laboratory techniques (safe handling practices, preparing and labeling samples and reagents for studies, proper use, storage, and disposal of reagents)
• Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology, research policies and guidelines and guidelines for packing/shipping infectious substances.
• Bilingual in Spanish and English or another language other than English.
• 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
  • Effective Cash Handling Procedures
  • Environmental Health and Safety Training
  • Fire Safety Training
  • Safe shipping practices (IATA)

About Us

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 here.

Join us to find a rewarding career contributing to improving healthcare worldwide.

Equal Employment Opportunity

The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law.

Salary Information

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.

To learn more about the benefits of working at UCSF, including total compensation, please visit: