What are the responsibilities and job description for the Clinical Research Coordinator Assistant position at University of California - San Francisco?
Under the supervision of a Clinical Research Supervisor or Principal Investigator (PI), the incumbent will perform entry-level duties related to the support and coordination of clinical studies, and may receive training and development to prepare and advance for journey-level work at the next level within the series. The Assistant Clinical Research Coordinator (CRC) will support and coordinate projects in the division of Allergy, Immunology, and Bone Marrow Transplant within the Department of Pediatrics. Assignments may change based on funding availability.
May be responsible for the coordination of one or more single or multi-site, active or follow-up clinical trials; help prepare protocols for study initiation; help design flow sheets, data forms and source documents; gather and interpret medical, surgical and laboratory data regarding clinical trial subjects; may apply understanding of inclusion/exclusion eligibility criteria for protocols; help recruit, enroll, register, schedule and retain study subjects; record protocol specific treatments and assure collection and shipment of samples; assist research personnel to keep patients on study schedules; complete study forms to submit to sponsors and/or appropriate agencies; collect, enter and clean data into study databases, maintaining data quality; assist with data analysis; assist with preparation of reports and tables; attend team meetings; and perform other duties as assigned.
% of time (Nothing less than 5%) | Essential Function (Yes/No) |
Key Responsibilities (To be completed by Supervisor) |
20% | YES | Patient Management Working in collaboration with others, schedules and tracks patient visits, tests, procedures and follow up according to protocol; provides calendars and schedules to patients; obtains insurance authorization for tests/procedures; in collaboration with team members, codes and documents toxicities and adverse events; reports adverse events to appropriate University and outside agencies; obtains, processes and ships specimens.
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20% | NO | Patient Registration Works with Investigators to verify history and medical information to assure inclusion/exclusion criteria are met; schedules screening tests and procedures; registers and randomizes patients on trials and/or studies.
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40% | YES | Data Management Abstracts clinical data from medical records; enters data onto case report forms, study flow sheets, and other forms; submits required data and data forms in accordance with accuracy and timeliness requirements of the protocols; addresses and resolves data queries; identifies, investigates and resolves data quality issues |
20% | YES | Miscellaneous Helps prepare for audits/monitoring visits by sponsors and/or regulatory agencies; Monitors study supply inventory and reorders as needed; maintains research charts and study binders; and performs other related duties as assigned. Maintains IRB applications and other regulatory documents as directed.
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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:
- HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/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 detail.
- Proficiency with Microsoft Word, PowerPoint, 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.
Preferred Qualifications:
- Demonstrated 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.
- 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
Required Qualifications:
- HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/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 detail.
- Proficiency with Microsoft Word, PowerPoint, 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.
Preferred Qualifications:
- Demonstrated 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.
- 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
Equal Employment Opportunity: The University of California San Francisco is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.