Clinical Research Coordinator - Pediatric Gastroenterology (Oakland) @ iazuqy.fa.ocs.oraclecloud.com

The location of this position is Benioff Children's Hospital in Oakland, CA

The Clinical Research Coordinator (CRC) 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) in the Department of Pediatrics. This position will operate in one or more divisions within the Department of Pediatrics and will likely support multiple investigators. Assignments may change based on funding availability. May coordinate the operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies.

The position’s duties include enrolling patients in clinical studies, data entry and management, biospecimen collection and processing, attending and documenting proceedings at relevant meetings, preparing grant proposals and reports, completing regulatory documents, Institutional Review Board applications, revisions and reports, and other duties as assigned.

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 and assist the 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 Institutional Review Board 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.

Department Overview

The Department of Pediatrics is one of the largest and most complex departments in the School of Medicine (SOM). The Department is comprised of 18 divisions employing over 400 core faculty, 83 fellows, 84 residents, 31 Post Docs and non-faculty academics, and 300 staffs. The Department has annual clinical income from inpatient and outpatient activities totaling over $100 million and annual extramural funding (contracts and grants) exceeding $58 million. The Department ranks 21st in the nation among pediatric departments for funding from the National Institutes of Health (NIH).

The Department’s clinical enterprise is based at the 183-bed UCSF Benioff Children’s Hospital San Francisco, the 191-bed UCSF Benioff Children’s Hospital Oakland, Mount Zion, Zuckerberg San Francisco General, and at a number of outreach clinics throughout Northern California, providing the Department with an unsurpassed opportunity to meet the needs of infants, children, and young adults throughout the Bay Area. In 2020, UCSF Benioff Children’s Hospitals ranked in all 10 children’s specialties in U.S. News and World Report.

% of time

(Nothing less than 5%)

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

20%

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.

5%

NO

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

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%

YES

Protocol Submission/ 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.

30%

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.

5%

YESRegulatory 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.

5%

YESStaff 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

5%

YESFinancial Support

• Track invoiceable items across research studies.
• Help prepare and track subject reimbursements and distribute stipends.
• At time of informed consent, describe to subjects potential out-of-pocket costs for participation in research studies.

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%.)

Required Qualifications

• High School Diploma; or equivalent experience/training
• Excellent verbal and written communications and presentation skills; excellent organizational skills; and excellent interpersonal skills to work effectively in a diverse team.
• Attention to details; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions and companies; and the ability to multi-task in a fast-paced environment while working with a diverse subject population
• Proficiency with Microsoft Word, PowerPoint, and Windows
• Excellent analytical and problem-solving skills
• Ability to work well independently and complete projects in a timely manner; 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

Preferred Qualifications

• Demonstrate proficiency with medical terminology
• Experience working with patients or study subjects
• Ability to abstract data from medical records and transfer it to data collection forms or directly into databases
• Fluency in the usage of Committee of Human Research (CHR) online iMEDris 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
• Experience with electronic medical records
• 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
• Knowledge of UCSF guidelines for research, confidentiality and Health Information and Accountability Act (HIPAA) regulations, following the UCSF mission statement and purpose for research, and clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.)
• Experience applying the following regulations and guidelines:
• Good Clinical Practice Guidelines
• HIPAA
• The Protection of Human Research Subjects