This is a position within the Division of Child Neurology in the Department of Neurology and Department of Neurosurgery at UCSF Benioff Children’s Hospital, San Francisco.

The Clinical Research Coordinator will manage and coordinate research protocols, as directed by Dr. Nalin Gupta. The CRC will be responsible for working as part of a team to coordinate data collection and operations of several concurrent clinical research studies and clinical trials in compliance with UCSF and regulating agency policies. This job will involve close work with children and families, including study participant enrollment at Benioff Children’s Hospital Mission Bay and Oakland, and adult participants at UCSF Medical Center at Parnassus, telephone calls to families and follow-up in pediatric neurosurgery research studies. Preference will be given to candidates that are able to commit to a minimum of 2-years.

The duties may include, but will not be limited to supporting the management and coordinating the tasks of multiple clinical research studies, including multi-center 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; assist the PI with oversight of students and 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. Incumbent will also assist with preparation of grant submissions.

The ideal candidate is an excellent communicator who enjoys speaking with families and is sensitive to the challenges of having a child with special needs.

of time

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

50%

Yes

Study Coordination

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.

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.
Conduct reviews of medical charts and electronic records to extract medical information and other data for use in studies.
Collect, organize, and de-identify clinical imaging acquired to enable study analyses
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, audits and analysis in databases.
Work with Supervisor to maintain complete and accurate data in the study database; analyze the data as they become available.
Implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration.
Produce vector images for use as figures in study manuscripts

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 and logs of data transfer or modification.

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

25%

Yes

Clinical Trials and Multi-Center Study Management

Manage infrastructure before and during study execution, including database management, space allocation, equipment procurement, and specimen/sample storage and transportation; work with leadership to ensure proper execution of studies.
Collaborate with other Universities, clinical entities, and industry using collected data to understand disease progression and predictors.
Provide ongoing staff training, ensure continued compliance, coordinate amendment updates, maintain study files, ensure audit readiness, recruit patients, and track enrollment; lead staff to ensure proper close-out of studies, discuss subjects’ options, and ensure that documentation and storage of study files meets legal requirements.
Ensure optimal systems are in place to ensure compliance with regulatory requirements for the safe conduct of clinical research. Ensure all CHR documents are up to date.
Oversee preparation of new CHR applications; arrange paperwork for renewal of existing protocols; respond to CHR requests for revisions; and coordinate protocol changes with study sponsors.
Ensure reporting of protocol violations to study sponsors and reporting of adverse events to the CHR in a timely manner.
Respond to requests and reviews of studies from sponsors, study monitors, FDA, and other entities, including complex audits of study performance.
Provide periodic status reports to project executives and coordinate documentation and archiving of project deliverables
Act as regulatory authority and advisor by training and educating employees and advising leadership and PI’s.

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.

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.

Yes

Grant Support

Pre-Award

Work with the pre-award office to prepare budgets
Draft and edit grant proposals
Prepare and compile documents for grant submission, including biosketches, letters of support and university documents

Post Award

Oversee budgets, invoices, and reimbursements.
Along with the PI, create and maintain the annual study budget, monitoring all items posted on ledgers, and ensuring that future budget projections are consistent with remaining funds.
Responsible for ensuring that the use of research funding is in compliance with funding agency protocols.
Assist PI in grant development, focusing on budget development.

10%

Other duties to be assigned by PI including but not limited to

Admin, Meetings, Training and On Boarding

Assist with admin items for the International Pediatric Stroke Organization
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
Literature reviews
Facilitate onboarding for visiting students, residents, fellows and faculty

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.

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%.)

HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities or equivalent experience/training.

Preferred Qualifications:

BA or BS degree
Society of Clinical Research Associates (SOCRA) Certification
1+ years experience with medical records review and data extraction
2+ years experience with clinical research study coordination
Experience with research study budget preparation
2+ years experience with project coordination for clinical trials
1+ yr experience working with CHR
1+ yr experience with project coordination for multi-center trials
Working knowledge of programming languages such as R or Python
1+ yr experience with medical imaging data, namely DICOM
1+ yr experience with producing images for manuscript figure
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

Clinical Research Coordinator

Job Description