Portland VA Research Foundation
  • 14-May-2021 to 13-Jul-2021 (PST)
  • R and D Admin
  • Portland, OR, USA
  • Salary
  • Full Time

Health, Dental, Vision, Life & Disability, 401k, PTO


IRB Analyst

SUMMARY

The Research Administrative Office of the Portland VA Health Care System is the administrative unit that provides Principal Investigators (PIs) and their support staff with the assistance necessary to conduct their individual research programs. The primary purpose of this position is to provide guidance on Human Research Protection Program (HRPP) regulations, policies and procedures to the PI and their support staff, and review documents submitted to the Institutional Review Board (IRB) for accuracy, consistency and completeness. This position is the liaison between the IRB Chair and members and the PI and their support staff.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Manage the day-to-day operations of assigned Institutional Review Boards (IRBs) to include:

  • Technical review of research proposals through all phases of a study
  • Meeting preparation and minutes capture
  • Training of research personnel as well as committee members
  • Provide authoritative interpretation and guidance of applicable regulations, directives, policies, handbooks, etc. as it relates to the operations of a human research protection program

JOB DUTIES

Research Proposals 40 percent

  • Conducts and completes pre-review of initial and continuing review questionnaires, assessing submitted documents for accuracy, consistency and completeness.
  • Enters data into appropriate Research Office databases for tracking and reporting purposes, and routes submitted VA and non-VA research proposals in a timely manner to assure appropriate deadlines are met.
  • Ensures that required subcommittee reviews are scheduled and that all required approvals are obtained
  • Reviews proposals and determines whether the submitted paperwork may be processed using an expedited review
  • Follows-up with IRB reviewer as necessary to assure all documents are reviewed and returned to meet established deadlines.
  • Completes minutes text within the appropriate Research Office database
  • Maintains a working knowledge of current Veterans Affairs Central Office (VACO), Food and Drug Administration (FDA), Department of Health and Human Services (DHHS) and Public Health Service (PHS) policies, regulations and guidelines.
  • Assists in the development of a general workflow sequence to prioritize the completion of IRB minutes and correspondence.
  • Evaluates current workload regularly and integrates these evaluations with the general workflow sequence to determine and organize work priorities.
  • Cultivates strong, professional rapport and utilizes this skill when involved in telephone and written communications and during person-to-person contact with other Research Office staff and Research Service staff.
  • Provides on-going feedback regarding current, evolving, and new IRB forms and office procedures to help ensure the highest possible efficiency and satisfaction of Research Service staff.
  • Coordinates activation of the electronic flag in the medical record to alert health care providers that the patient is enrolled in a moderate to high risk research protocol.
  • Coordinates requests for poster ordering through VA vendor and ensures that all appropriate documents are completed for appropriate billing to occur.
  • Reviews scope of work forms to ensure information is accurate and consistent with protocol paperwork; routes the forms for authorized signature and enters information into the appropriate Research Office database.
  • Reviews education verification documents assuring that individuals who are, or have the potential to be, licensed, certified or registered have been submitted to Medical or Nurse Professional Service to have their background entered and information verified in the VA provider database.
  • Runs monthly reports to cross reference current and proposed personnel at the Portland VA against the List of Excluded Individuals/Entities and the FDA's debarment list to assure there are no matches; if a match is found, notifies appropriate personnel for necessary action and follow-up.
  • Collaborates as part of an implementation team for the Combined PVAMC-OHSU IRB, ensuring that VA research requirements will be met, determining details of how coordination of the committee will occur.

Committee and Subcommittees 25 percent

  • Creates presentation materials by identifying which studies can be reviewed, assigns appropriate committee and/or subcommittee reviewers and coordinates schedules of committee and/or subcommittee members.
  • Assembles IRB review binders, photocopies meeting materials, distributes binders and primary reviewer materials to attendees and generates agendas.
  • Records, processes and distributes accurate minutes and correspondence for all relevant committees and/or subcommittees in a timely manner.
  • Demonstrates a working knowledge of the policies, regulations and guidelines governing the various committees and subcommittees and keeps supervisors and committee members apprised.
  • Maintains effective communication with the Chairs/members of relevant committees and subcommittees.
  • Distributes the appropriate review forms for various committees and subcommittees and provides necessary follow-up to bring these reviews to closure.
  • Develops processes to ensure that quality is planned, developed, and implemented to identify, prevent and correct unsatisfactory conditions and elements which may influence transactions and services.

Data Management 25 percent

  • Enters data relating to committee membership, funding sources, personnel and submitted
  • paperwork for new and initial projects into the appropriate Research Office databases.
  • Performs file and database audits and follow-up procedures on studies to ensure accurate, appropriate committee actions and file documentation of the actions.

Studies and Special Projects 10 percent

  • Provides input and recommendations for training programs and organizational strategies to identify opportunities to improve customer service and process quality.
  • Performs other related duties as assigned.

QUALIFICATIONS

Ability to perform essential job duties with or without reasonable accommodation and without posing a direct threat to safety or health of employee or others. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

Experience reading, interpreting, and applying human subjects' research protection rules, regulations, and policies in support of an institutional review board (IRB). Experience may have been gained either through direct support of an IRB or through study coordinator work in support of a human research project.

LANGUAGE SKILLS

English proficiency is required.

COMPUTER SKILLS

Ability to proficiently use MS Office Suite with emphasis on Word, Excel, Outlook and Access. Must be familiar with web browsers such as Edge and Chrome, and proficient at typing (average of 50wpm is preferred).

REASONING ABILITY

Must be able to read, interpret and apply technical and complex concepts as they relate to human subjects research. Requires strong analytical skills.

Portland VA Research Foundation is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, color, sex, sexual orientation, gender identity, religion, national origin or age.

Apply online at http://www.pvarf.org and include a CV and cover letter explaining your interest in the position


Portland VA Research Foundation
  • Apply Now

  • * Fields Are Required

    What is your full name?

    How can we contact you?

  • Sign Up For Job Alerts!

  • Share This Page
  • Facebook Twitter LinkedIn Email
.
logo Human Resources & Job Opportunities Home About the Foundation Research and Education Accounting Donate: Support the Work Human Resources