U
Clinical Research Coordinator - Endocrinology (Part-Time)
UCSF
10 hours ago
Full-time
On-site
San Francisco, California, United States
Registered Nurse
This 50% position (20 hours per week) will involve conducting on-site study
visits at UCSF Benioff Children’s Hospitals in San Francisco (Mission Bay) and
Oakland. Flexibility is required, since the needs of the study will determine
the work location and the number of hours worked on any given day.
Duties include conducting study visits, participant recruitment, data entry,
regulatory maintenance, conducting monitoring visits, submitting to the
Institutional Review Board, and other study coordination duties.
Please review the details about this role and determine if this seems like a
good fit for you:
* This position is 20 hours per week, primarily Monday through Friday.
* The number of hours worked per day varies each week depending on the needs of
the studies.
* Most study visits start in the morning (you would arrive onsite at UCSF in
either San Francisco Mission Bay or Oakland around 7:30am).
* Some remote work may be possible depending on the needs of the studies and
current department policies.
* There are occasional evening hours (6 or 7pm) and very rare weekend hours to
accommodate our patients’ schedules, usually for a phone call to discuss the
study (usually done remotely).
* There is the possibility of increasing the number of hours per week in the
future.
The Clinical Research Coordinator (CRC) under general direction, independently
manages and coordinates research protocols mainly for children with hormone
conditions. They 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. Responsibilities include
overseeing multiple clinical studies, ensuring regulatory compliance, managing
data and documentation, supporting IRB submissions, maintaining data quality,
coordinating staff activities, and participating in audits while adhering to
UCSF policies and research guidelines.
CRC 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; create, clean, update, and manage databases and comprehensive
datasets and reports; coordinate staff work schedules, 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 Institutional
Review Board (iRIS) 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.
Other duties will include recruiting participants for multiple studies in
pediatric endocrinology, including contacting participants by phone, email,
Zoom/video, or in person. The majority of these studies will require working
closely with other researchers, hospital clinic staff, children and their
families, onsite, at both Benioff Children’s Hospitals in San Francisco (West
Bay) and in Oakland (East Bay).
RESPONSIBILITIES
Key Responsibilities
%
of time
Essential Function (Yes/No)
Key Responsibilities
30
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.
20
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.
10
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
* 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.
* 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.
5
YES
Quality control procedures
10
YES
STUDY IMPLEMENTATION
5
YES
SPECIMEN MANAGEMENT/ MAINTENANCE
15
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.
QUALIFICATIONS
Required Qualifications:
* High School Diploma; or equivalent experience
* Excellent verbal and written communication, organizational, and interpersonal
skills to work effectively in a diverse team
* 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 multitask 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
* Proficiency with Microsoft Word, PowerPoint, Excel, Outlook, and Windows
* Excellent analytical and problem-solving skills
* Ability to work effectively in a fast-paced, team-based environment; project
management and coordination skills; ability to prioritize tasks and meet
multiple deadlines on concurrent projects
* Ability to establish cooperative working relationships with patients,
co-workers, & physicians
* Experience and/or comfort working with children, adolescents, and families
Preferred Qualifications:
* Pediatric research experience
* Career interest in working with children and/or adolescents and their
families
* Fluency in the usage of Institutional Review Board (IRB) online iRIS 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
* Certification by the Society of Clinical Research Associates or the
Association of Clinical Research Professionals
* Experience with accessing electronic medical records and entering the data
into REDCap and other platforms
* 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
* IRB regulations for recruitment and consent of research subjects
* Effective Cash Handling Procedures
* Environmental Health and Safety Training
* Fire Safety Training
visits at UCSF Benioff Children’s Hospitals in San Francisco (Mission Bay) and
Oakland. Flexibility is required, since the needs of the study will determine
the work location and the number of hours worked on any given day.
Duties include conducting study visits, participant recruitment, data entry,
regulatory maintenance, conducting monitoring visits, submitting to the
Institutional Review Board, and other study coordination duties.
Please review the details about this role and determine if this seems like a
good fit for you:
* This position is 20 hours per week, primarily Monday through Friday.
* The number of hours worked per day varies each week depending on the needs of
the studies.
* Most study visits start in the morning (you would arrive onsite at UCSF in
either San Francisco Mission Bay or Oakland around 7:30am).
* Some remote work may be possible depending on the needs of the studies and
current department policies.
* There are occasional evening hours (6 or 7pm) and very rare weekend hours to
accommodate our patients’ schedules, usually for a phone call to discuss the
study (usually done remotely).
* There is the possibility of increasing the number of hours per week in the
future.
The Clinical Research Coordinator (CRC) under general direction, independently
manages and coordinates research protocols mainly for children with hormone
conditions. They 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. Responsibilities include
overseeing multiple clinical studies, ensuring regulatory compliance, managing
data and documentation, supporting IRB submissions, maintaining data quality,
coordinating staff activities, and participating in audits while adhering to
UCSF policies and research guidelines.
CRC 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; create, clean, update, and manage databases and comprehensive
datasets and reports; coordinate staff work schedules, 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 Institutional
Review Board (iRIS) 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.
Other duties will include recruiting participants for multiple studies in
pediatric endocrinology, including contacting participants by phone, email,
Zoom/video, or in person. The majority of these studies will require working
closely with other researchers, hospital clinic staff, children and their
families, onsite, at both Benioff Children’s Hospitals in San Francisco (West
Bay) and in Oakland (East Bay).
RESPONSIBILITIES
Key Responsibilities
%
of time
Essential Function (Yes/No)
Key Responsibilities
30
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.
20
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.
10
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
* 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.
* 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.
5
YES
Quality control procedures
10
YES
STUDY IMPLEMENTATION
5
YES
SPECIMEN MANAGEMENT/ MAINTENANCE
15
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.
QUALIFICATIONS
Required Qualifications:
* High School Diploma; or equivalent experience
* Excellent verbal and written communication, organizational, and interpersonal
skills to work effectively in a diverse team
* 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 multitask 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
* Proficiency with Microsoft Word, PowerPoint, Excel, Outlook, and Windows
* Excellent analytical and problem-solving skills
* Ability to work effectively in a fast-paced, team-based environment; project
management and coordination skills; ability to prioritize tasks and meet
multiple deadlines on concurrent projects
* Ability to establish cooperative working relationships with patients,
co-workers, & physicians
* Experience and/or comfort working with children, adolescents, and families
Preferred Qualifications:
* Pediatric research experience
* Career interest in working with children and/or adolescents and their
families
* Fluency in the usage of Institutional Review Board (IRB) online iRIS 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
* Certification by the Society of Clinical Research Associates or the
Association of Clinical Research Professionals
* Experience with accessing electronic medical records and entering the data
into REDCap and other platforms
* 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
* IRB regulations for recruitment and consent of research subjects
* Effective Cash Handling Procedures
* Environmental Health and Safety Training
* Fire Safety Training