Clinical Research Coordinator - Division of HIV

University of California, San Francisco•San Francisco, CA

2d•Onsite

About The Position

The Clinical Research Coordinator (CRC) will execute, manage, and coordinate research protocols under the direction of the Clinical Research Supervisor and/or Principal Investigator (PI). This role may involve coordinating data collection and operations for multiple concurrent clinical research studies, adhering to protocol guidelines and UCSF/regulatory agency policies. The CRC will support the management of clinical research studies, act as an intermediary between departments, manage data and specimen management, and report on study results. They will also assist in training Assistant CRCs and overseeing other research staff. Key duties include managing Investigator’s protocols in the Committee on Human Research (CHR) online system, handling renewals and modifications, and implementing new studies. The CRC will participate in protocol review and writing to ensure IRB approval and University compliance, help ensure compliance with regulatory agencies, oversee study data integrity, implement quality control procedures, and interface with departments for UCSF approval. They will maintain regulatory documents, report study progress, participate in audits, and perform other assigned duties. Specifically, this CRC will support a large NIH-funded study focused on real-time monitoring of alcohol use using a wrist-worn biosensor and daily cell-phone surveys over a 28-day period. The goal is to establish a gold standard for determining the best cutoff for the phosphatidylethanol (PEth) alcohol biomarker. The CRC will be responsible for screening and enrolling participants, scheduling visits, obtaining informed consent, training participants on technology use, conducting surveys, performing finger-pricks for blood spot collection, and taking non-invasive body composition measurements. They will also assist in protocol development, monitor data completeness and participant compliance, track and distribute remuneration, maintain specimen tracking, oversee shipping for lab analysis, report on recruitment and retention, and assist with regulatory issues like IRB compliance and NIH progress reports.

Requirements

High School Diploma; or equivalent experience
Attention to detail
Strong interpersonal skills
Excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments, and outside institutions
Ability to multi-task in a fast-paced environment while working with a diverse subject population
Ability to work well independently
Ability to complete projects in a timely manner
Ability to prioritize multiple projects to ensure the completion of essential tasks by deadlines

Nice To Haves

Fluency in Spanish
Understanding of patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation.
Bachelor’s or Master’s degree in biological sciences or public health
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 research policies and guidelines, guidelines for packing/shipping non-infectious substances
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

Responsibilities

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.
Train study participants on use of alcohol biosensor (syncing, charging) with an iOS device and on use of cell-phone based daily alcohol surveys.
Conduct fingerpricks and preparing dried blood spots as well as point of care hemoglobin testing and measurements of body composition such as weight, height, and waist and hip circumferences.
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.
Help train staff and others on new research protocols, changes in procedures, study protocols, data collection/entry, database procedures, medical chart review and storage, and other procedures.
Attend and actively participate in regular team meetings.
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.
Load biosensor data into device dashboard on an ongoing basis to check for non-wear or device difficulties and monitor survey data to determine daily completion; trouble shoot with participants in real time to obtain high completion rates.
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.
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.
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.
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.