Clinical Research Coordinator - Pediatric Gastroenterology (Oakland)
Description
**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
| ||
5% | NO | Quality Control Procedures
| ||
20% | YES | Data Management and reporting of results
| ||
10% | YES | Protocol Submission/ Adherence
| ||
30% | YES | Study Implementation
| ||
5% | YES | Regulatory Responsibilities
| ||
5% | YES | Staff Training
| ||
5% | YES | Financial Support
| ||
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
Skills
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