Research Assistant II

Position Definition: 

The Clinical Research Coordinator will be based at the San Francisco Veterans Affairs Medical Center (VAMC) working collaboratively within the Division of Gastroenterology and Hepatology as well as across other Divisions at the VAMC and UCSF. The incumbent will perform independently or with general direction 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, University of California San Francisco (UCSF) and regulating agency policies.

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.

The primary purpose of the position is to assist in clinical research of patients with Liver Disease and at risk for Liver Disease involving data extraction and collection, from the electronic health record and other databases, acquisition of data directly from human subjects, and regulatory compliance.

Essential Functions:

• Responsible for data collection and extraction of data elements from electronic health records. Organize and transform data as needed for further analysis. Review, extraction and cleaning of data from other databases may also be needed. Incumbent may need to obtain data directly from human subjects, including making phone calls, administering surveys and performing interviews.
• Data presentation and analysis duties. Incumbent will organize data and other information for further analysis and will also assist with preparing materials for presentations and publication.
• Research support duties. Incumbent will assist the research team with other tasks necessary to conduct research, including facilitating communications with collaborators and support staff, ordering supplies, and maintenance of equipment and other research assets.
• Prepare study materials including, but not limited to, regulatory paperwork, informed consent document, case report forms (CRFs), enrollment logs, participant reimbursement, and drug accountability logs.
• Establish and organize HIPAA compliance
• study files, including but not limited to, regulatory binders, study specific source documentation and other materials.
• Contribute to the preparation and participation in quality assurance activities (monitoring visits and sponsor audits).
• Ensure that all VA sensitive information is being used, stored and secured in accordance with the VHA policies and guidance.
• Maintains files documenting research training modules, credentials, research-related TMS certificates, CVs, and other related materials for each study team member.
• Maintaining reliable and regular contact with faculty and keep PI apprised of study updates.
• Performs other related duties as assigned by the PI.

Required Qualifications:

• Attention to detail and the ability to multi-task in a fast-paced environment while working with a diverse subject population.
• Experience with data management
• Strong interpersonal skills, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions.
• Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.
• Prior experience in coordinating study recruitments in clinical research environments and differing participant pools and following existing strategies to meet current recruitment goals
• Prior experience in designing and enhancing forms for data collection, manuscripts. Demonstrate ability to develop and maintain systems for assuring protocol adherence and data quality
• Bachelor’s degree and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
• Ability to work on site at the San Francisco VAMC.
• Preferred Experience with electronic medical records.
• Preferred Knowledge of medical terminology, research policies and guidelines.
• Preferred Experience with database building, analysis, and data management within some of the following: Access, Stata, Excel.

Working Conditions/Environment:

The work environment for this position will include an indoor office and a medical research environment.  It may include some minor annoyances such as noise, temperature variations, etc. The incumbent may sustain posture in standing or seated position and may utilize a computer terminal for prolonged periods of time.

Salary : $24 - $34