Clinical Research Coordinator

Responsibilities

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); will 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 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, recruit and train Assistant CRCs for the research team, 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 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 by the PI

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

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

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

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

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

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

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

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

Benefits

Flexible work arrangement: 2 days on-site

UCSF Health offers healthcare services in the areas of cancer, heart disorders, neurological disorders, organ transplants, and more.

San Francisco, California, USA

https://www.ucsfhealth.org

Late Stage

Leadership Team

Elizabeth Engel

Executive Director - UCSF Health Converge

Mitchell Rosen, UCSF

Assistant Professor

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Qualifications

Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the ability to multi-task in a fast-paced environment while working with a diverse subject population

Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines

HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities

Required skills

Represents the skills you have, click on the tags, Project Coordination

Experience

Mid level