Clinical Research Coordinator Surgery

UCSF•San Francisco, CA

3d•$40 - $45

About The Position

The Clinical Research Coordinator 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. Incumbent’s 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 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.

Requirements

HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
Attention to detail.
Strong interpersonal skills.
Excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions.
Ability to multi-task in a fast-paced environment while working with a diverse subject population.
Ability to work well independently.
Ability to complete projects in a timely manner.
Ability to prioritize multiple projects to ensure the completion of essential tasks by deadlines.

Nice To Haves

Bachelor's degree
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.
Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals
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, 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, CHR regulations for recruitment and consent of research protocols, Effective Cash Handling Procedures, Environmental Health and Safety Training, Fire Safety Training.

Responsibilities

Execute, manage, and coordinate research protocols.
Coordinate data collection and operations of clinical research studies.
Support the management and coordination of single or multiple clinical research studies.
Act as an 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.
Assist Clinical Research Supervisor and/or PI with oversight of other research staff.
Manage Investigator’s protocols in the Committee on Human Research online system, including renewals and modifications.
Implement new studies.
Participate in the review and writing of protocols to ensure institutional review board approval within University compliance.
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 internal and external audits or reviews of study protocols.
Perform other duties as assigned.