Clinical Research Coordinator - Division of HIV

Job Summary:

The Clinical Research Coordinator will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Clinical Research Supervisor and/or 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.

Incumbent's duties may include, but will not be limited to supporting the management and coordinating the tasks of single or multiple clinical research studies, depending on their size and complexity; act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results;; assist with training of Assistant CRCs, and assist Clinical Research Supervisor and/or PI 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 is being hired to support a large NIH funded research study to use real-time monitoring of alcohol use as the gold standard to determine the best cutoff for an alcohol biomarker called phosphatidylethanol (PEth), that is found in blood tests. The real-time monitoring will be using a wrist-worn biosensor and daily cell-phone based surveys over a 28-day study period. The CRC will conduct screening and enrolling study participants, scheduling study visits, and will conduct all participant facing procedures including gaining informed consent, training and supporting participants on the use of the technology associated with the study, conducting study surveys, performing finger-pricks for blood spot collection, and conducting non-invasive measurements of body composition such as height, weight, waist and hip measurements. The CRC will assist in development and maintaining protocols, conducting real-time checks for data completeness and participant compliance, and will track and distribute study remuneration. The CRC will maintain study specimen tracking and oversee shipping for laboratory analysis. The CRC will report on participant recruitment and retention and may assist with regulatory issues such as IRB compliance and NIH progress reports.

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.

Required Qualifications:

• 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; 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 Qualifcations:

• 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

%

of time

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

5065

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.

• 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.

50

YES

Data Management and Reporting of Results

• 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 or NO

Staff Training

• 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

10

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
• 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

10

YES

Study Implementation

• 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.

10

YES

Specimen Management/ Maintenance

• 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.

50

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.

50

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.

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%.)

%

of time

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

5065

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.

• 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.

50

YES

Data Management and Reporting of Results

• 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 or NO

Staff Training

• 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

10

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
• 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

10

YES

Study Implementation

• 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.

10

YES

Specimen Management/ Maintenance

• 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.

50

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.

50

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.

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%.)