The posting
Job Description
The Clinical Research Coordinator (CRC) will join the GI Division and responsibilities will include coordination of clinical research studies related liver disease and liver transplantation. The Clinical Research Coordinator will perform independently at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Principal Investigator (PI); may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies. The CRC will work on the DeLIVER Care, provides HCV screening and low-threshold standard of care HCV treatment on at various locations in San Francisco on a mobile van.
CRC’s duties may include, management and coordinating the tasks of multiple clinical research studies, 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; coordinate staff work schedules, assist with training of Assistant CRCs, and assist PI supervisor with oversight of other research staff; manage Investigator’s protocols in the Committee on Human Research online system, as well as renewals and modifications of protocol applications and the implementation of new studies; participate in the review and writing of protocols to ensure institutional review board approval within University compliance; 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 also be responsible for performing fingersticks for rapid HCV antibody testing and/or HCV RNA, venipuncture for HCV RNA confirmatory testing and other labs, driving the van, and completing research activities such as consenting participants, extracting information from medical records, completing case report forms, data collection, and data entry. The CRC is required to be experienced in research with “hard-to-reach” and vulnerable populations, knowledge of resources for HCV and HIV prevention and education, drug abuse prevention and treatment, and street and community-based outreach methods. Phlebotomy certification is preferred, but not required. Having experience performing phlebotomy with people experiencing homelessness and people who inject drugs is preferable.
Responsibilities
%
of time
Essential Function (Yes/No)
Key Responsibilities
(To be completed by Supervisor)
20
YES
Study Coordination and Data Collection
- Identify subjects, develop recruitment and retention strategies, and screen and enroll study subjects.
- Schedule subjects for study visits; meet with them to administer questionnaires, collect medical history and perform study procedures.
- Maintain rapport and relationships with subjects to ensure effective communication and retention; respond to their diverse needs, schedule follow-up appointments, and become their intermediary; discuss study outcomes with providers to ensure continuity of care.
- Obtain informed consent; review information with subjects; assess and advocate for patient safety throughout each protocol procedure.
- Oversee subject reimbursement; work to resolve discrepancies and issues.
- Work with staff to ensure procedures are completed, specimens properly stored, and required data collected at visits; and ensure correct shipping and labeling measures.
- Coordinate, communicate and network with other studies and technicians to ensure scheduling efficiency; communicate with any affiliated groups.
- Conduct reviews of medical charts and electronic records to extract medical information and other data for use in studies.
- Implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration.
- set up approved studies in APEX and OnCore, identify all study subjects in APEX to ensure research related expenses are billed to the study and that the patient’s insurance is billed for standard of care expenses.
- review APEX work queue on a daily basis, resolve incorrect patient billing issues.
- identify non-standard of care patient care costs and procedures related to the study, complete a monthly invoice form and provide it to the research finance analyst (RFA) for payment from the sponsor.
- prepare check requests for participation in the study as well as for issuing reimbursement for travel, as stipulated in the consent form.
45
YES
Specimen Management/ Maintenance
- Follow designated procedures as described in the individual study protocols using aseptic techniques and ensuring participant safety during the phlebotomy process.
- Follow designated procedures as described in the individual study protocols for specimen collection using urine samples and finger pricks.
- Arrange the exchange of and transport of specimens with collaborating Investigators and staff.
- Oversee the incoming data interpreted from samples and ensure that it is utilized correctly for analysis and publications.
- Ensure integrity and security of samples.
- Maintain temperature logs
- Maintain and organize -80 freezers
- Maintain Cyro Storage
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
- Suggest modifications to the administrative infrastructure to accommodate increasing complexity of studies.
- Modify data collection instruments
- Help schedule staff time and coordinate staff schedules.
- Maintain subject tracking systems.
- Collect data during subject visits; enter data from visits, procedures, lab tests, and other subject-related participation into databases in a timely manner.
- Manage database structure for each protocol; update databases to improve data analysis and management; create new databases as needed.
- Create and maintain comprehensive data sets as requested by the CRC Supervisor and/or PI.
- Maintain data collection forms for effective data collection, entry, and analysis.
- Perform queries and analysis in databases.
- Work with Supervisor to maintain complete and accurate data in the study database; analyze the data as they become available.
5
YES
Study Implementation
5
YES
Data management
5
YES
Protocol Submissions and Adherence
- Enter all existing and new study protocols into the Committee on Human Research (CHR) online system; seek assistance on maintaining all protocols in the system by communicating with CHR Analysts.
- Design and enhance case report forms and data collection forms as needed; provide manuscript feedback; continue to develop and maintain systems for assuring protocol adherence and data quality.
- Participate in the review and writing of protocols and related procedures to ensure institutional review board approval within university compliance.
- Renew, modify, and submit CHR applications and protocols; ensure that protocol applications are submitted in a timely manner; serve as a liaison between CHR and study Investigators.
- Provide quality assurance checks to note if protocols or UCSF CHR applications need to be modified; evaluate protocols on an ongoing basis and implement improvements as needed.
5
YES
Regulatory responsibilities
- Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations.
- Initiate and follow-up on CHR submissions and modifications; track approval status.
- Interface with departments to obtain UCSF approval prior to study initiation.
- Maintain regulatory documents; monitor timelines for data submission; document adverse events and submit to appropriate departments.
- 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.
10
YES
Driving responsibilities
- Responsible for driving the university van to and from outreach shifts and vehicle maintenance services
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:
- California Driver's License
- High Schol Diplima; or equivalent experience/training
- Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the ability to multi-task in a fast-paced environment while working with a diverse subject population
- Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines
Preferred Qualifications:
- BA or BS in physical or biological sciences and one year of clinical research experience
- Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this 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 with electronic medical records
- 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, guidelines for packing/shipping infectious substances, database building/analysis, and data management within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms
- Experience applying the following regulations and guidelines: Good Clinical Practice Guidelines Health Information and Accountability Act (HIPAA) The Protection of Human Research Subjects CHR regulations for recruitment and consent of research subjects Effective Cash Handling Procedures Environmental Health and Safety Training Fire Safety Training Experience working with programs serving people experiencing homelessness and/or substance dependence
License/Certifications:
- California Driver's License Does the job demonstrably require driving as a core function? Yes Can the essential tasks of the role be performed adequately without driving? No- the CRC will be responsible for driving the van to and from outreach shifts and vehicle maintenance services If driving is required, would using alternative transportation (like public transit, carpooling) significantly impact the employee's ability to perform job duties in terms of time and cost to the employer? Yes If required to drive, will use of a university vehicle be required? Yes Will use of a personal vehicle be required? No Will the position be required to drive frequently (more than 10 hours month)? Yes Will position be required to drive outside of city or county limits? Yes Will position need to register with the California Pull Program? Yes
