Join Us! HRPP Recruiting for a Variety of Open Jobs

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The HRPP office now has a variety of job opportunities. Help us improve patients’ access to cutting edge research studies by working closely with physicians, scientists and study coordinators to facilitate the review and approval of human research applications.

Job Opportunity #1

Req. Number: 47325BR

IRB Manager (Research Compliance Supervisor II)

University of California, Department of Human Research Protection Program

Location: University of California, San Francisco – Laurel Heights

The IRB Manager is responsible for managing the IRB Analysts who process applications requiring review by either a convened panel of the IRB or by expedited review. The review process includes setting agendas, conducting meetings at which the studies are discussed, writing letters that convey the outcome of the committee review, review of PI responses to these letters, maintaining minutes of the Committee meetings. The IRB Review Unit is required to track all actions in a timely manner so that information is available for the Principal Investigators (PIs) and others as needed as quickly as possible.

It is the responsibility of the IRB to oversee operations of this unit, to supervise its staff, and to ensure that the operations are conducted in an effective and efficient manner and in accordance with the standards of time-to-completion (T2C) established as baselines. The IRB Manager provides leadership to the HRPP and manages and directs the activities of the IRB. The IRB Manager must collaborate with key research support units at UCSF to coordinate the delivery of those activities, such as the Regulatory Knowledge and Support Program, Clinical Research Services of the UCSF Clinical and Translational Science Institute (CTSI), the Helen Diller Family Comprehensive Cancer Center (HDFCCC), Center for AIDS Preventions (CAPS), and Global Health Sciences. Collaboration between HRPP and these other stakeholders is critical to ensuring quality, compliance, and providing an effective human subjects protection program. The IRB Manager reports to, and is accountable to the HRPP Director.

The Research Compliance Supervisor oversees a team of research compliance analysts who are responsible for screening and approving human research applications . Administers policies and procedures in designated research compliance area with established federal and state agency regulations. Receives assignments in the form of objectives with goals and the process by which to meet goals. Provides direction to staff according to established policies and management guidance. Administers policies that directly affect subordinate staff. Recommends changes to department policies and practices. Identifies risks and responds accordingly. Provides priority setting and work flow analysis.

For the full job description, go to http://ucsfhr.ucsf.edu/careers/

Contact person: Laurie Herraiz (Laurie.Herraiz@ucsf.edu)

Job Opportunity #2

Req. Number: 47219BR

Expedited Application Coordinator (Research Compliance Analyst IV)

University of California, Department of Human Research Protection Program

Location: University of California, San Francisco – Laurel Heights

Under the supervision of the IRB Manager, the Expedited Application Coordinator will screen initial review applications for expedited IRB review or exempt determinations. In many cases, and depending on the individual, the Expedited Application Coordinator will also serve as designated IRB reviewer with authority to approve or require changes to the research. The Coordinator will screen applications for completeness, level of review needed, and compliance with regulations and guidelines; return applications with stipulations if changes are needed; and assign completed applications to IRB chairs and members for formal review.
The individual will analyze and evaluate Committee decisions to ensure compliance with applicable regulations, policies and procedures. If any part of the decision is non-compliant, it is the responsibility for the Coordinator to take corrective action. The Coordinator is the person ultimately responsible for all IRB committee activities related to these studies, such as drafting correspondence to investigators, reviewing investigator responses, assisting with developing and improving systems and procedures for review, and educating investigators and members.

The Coordinator writes formal correspondence to the investigator based on both the Committee’s decisions and his or her own analysis of the protocol, reviews the investigator’s response, and determines the next steps (either soliciting more information from the investigator or forwarding the response to the Committee members for further consideration. At each step the Coordinator must evaluate researchers’ and members’ concerns and responses and advise them of federal, state, and local regulations and guidance that limit the committee’s decisions.

For the full job description, go to http://ucsfhr.ucsf.edu/careers/

Contact person: Joanne Mickalian, Joanne.Mickalian@ucsf.edu

Job Opportunity #3

Req. Number: 47217BR

IRB Assistant Coordinator (Research Compliance Analyst II)

University of California, Department of Human Research Protection Program

Location: University of California, San Francisco – Laurel Heights

Under the supervision of the Assistant Coordinator Manager, the IRB Assistant Coordinator is responsible for analyzing and processing submissions for the continuing review or modification of IRB-approved research. Individual will evaluate changes to approved research to ensure compliance with applicable federal regulations, state laws, and university policies and procedures. The IRB Assistant Coordinator must ensure that submissions meet basic standards for review so that the IRB, Chair, and/or designated reviewer are able to efficiently complete their regulatory and ethical reviews. The individual must ensure submissions receive an appropriate level of review (e.g., full board, expedited, exempt), and ensure IRB reviewers with appropriate expertise are assigned to the submission. If any part of the application is incomplete or non-compliant, it is the responsibility for the IRB Assistant Coordinator to take corrective action by communicating in writing, by phone and/or in person with the faculty investigator or his or her support staff.

Prior to formal review, the IRB Assistant Coordinator must be able to perform these tasks independently and with good judgment. After formal review, the IRB Assistant Coordinator generally performs this task at the direction of the IRB, Chair or expedited reviewer. The individual is responsible for processing and facilitating all stages of the review, from initial submission to final approval. The IRB Assistant Coordinator must have a strong customer service orientation, proven problem solving abilities, demonstrated oral and written communication skills in order to effectively assist and advise faculty or research administrators.

For the full job description, go to http://ucsfhr.ucsf.edu/careers/

Contact person: Joanne Mickalian, Joanne.Mickalian@ucsf.edu