U
Clinical Research Coordinator - Division of HIV
UCSF
10 hours ago
Full-time
On-site
San Francisco, California, United States
Registered Nurse
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.
RESPONSIBILITIES
%
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%.)
QUALIFICATIONS
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
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.
RESPONSIBILITIES
%
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%.)
QUALIFICATIONS
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