Compliance Administrator II for IRB

Job description

Posting Details

Position Information

Job TitleCompliance Administrator II for IRBDepartmentSponsored Projects and Research Compliance (SPARC)Full Time/Part TimeFull-TimeRequisition NumberS20169Open Date09/25/2019Close Date10/23/2019Salary Information

Salary Commensurate with Experience and Qualifications

Work Schedule

Monday through Friday, 8 a.m. to 5 p.m.

Benefits EligibleYesEligible for OvertimeNoPosition Summary

The Office of Sponsored Projects and Research Compliance (SPARC) is committed to supporting the research endeavors of faculty members and staff of Rice University, by helping them understand their obligations and ensure compliance with applicable governmental regulations and university policies. The Institutional Review Board (IRB) conducts review and approval of research that involves human participants.

The compliance administrator II for IRB is responsible for managing the IRB for the Protection of Human Subjects in Research. S/he will also manage and provide direction for the Human Research Protection Program (HRPP) at Rice. The compliance administrator II for IRB reviews, establishes, and implements policies and procedures for the HRPP. S/he will serve as the subject matter expert and advise and provide input to IRB and other stakeholders regarding regulations and policies.

SPARC seeks an individual who is comfortable collaborating with faculty and administrators, communicating federal and university requirements to university stakeholders, assisting in program and policy development in response to government agency updates, and handling multiple projects with competing deadlines.

Education RequiredBachelor's DegreeMajor/Discipline

Social science, natural science, or engineering field.

Substitution for Education Requirement

Experience may not be substituted for the education requirement.

Education Preferred

Master’s or doctoral degree.

Experience Required3 yearsType of Experience

Related work experience in any of the following:
- IRB research compliance
- Research administration
- Working in a regulatory environment with the ability to understand the federal laws, regulations, and procedures pertaining to human subjects research ethics

Substitution for Experience Requirement

Education may not be substituted for the experience requirement.

Experience Preferred

Three or more years in research administration.

License/Certification RequiredLicense/Certification Preferred

- Clinical Research Associate (CRA)
- Certified IRB Professional (CIP)

Skills Required

- Strong computer skills and understanding of databases (e.g., Microsoft Office Suite)
- Excellent verbal and written communication skills
- Organizational skills and the ability to manage multiple priorities
- Familiarity with IRB, IACUC, and/or IBC practices with regard to human/animal subjects, biosafety regulation, and federal and state policies and procedures

Skills Preferred

- Superior verbal and written communication skills
- Excellent collaborative, judgement, leadership, negotiation, problem solving, and critical thinking skills with attention to details and willingness to take initiative
- Ability to work independently and as part of a team to meet expected deadlines and schedules
- Excellent organizational and time management skills to plan and schedule
- Ability to work well under pressure and manage multiple projects simultaneously

Internal / External Contacts

Internal: Contact with undergraduate students, graduate students, postdoctoral fellows, departmental staff, staff in central administration, and faculty wishing to engage in research with humans and/or other research where specific compliance approvals are required
External: Contact with community members, universities, and federal regulatory agencies (e.g., National Institutes of Health)

Physical Demands

Requires working at a computer for extended periods of time (up to eight hours per day).

Working Conditions

General office environment

Security SensitiveYes Special Instructions to ApplicantsQuick Link for Postinghttp://jobs.rice.edu/postings/21425 Job Duties

Job Duty NameEssential FunctionsDescription of Job Duty

- Advises on the development and execution of policies and procedures in compliance with university and federal regulatory requirements
- Manages protocol activities, including notifications and verification of compliance with Rice’s policies and procedures
- Performs moderately complex protocol activities through consultation with his/her supervisor and compliance committee chair
- Plans and coordinates compliance review and follow-up activities
- Processes comments, reviews, and investigates responses
- Maintains and assists investigators with the protocol submission process, working with both internal and external groups on improving user experience
- Manages protocol files for internal and external audits in accordance with regulatory requirements and university policies and procedures
- Attends committee meetings and records meeting outcomes
- Assists in the preparation of institutional reports, program reviews, and federal reports for the compliance program
- Follows up on post approval issues; prepares correspondence; takes notes on discussions or actions during compliance meetings
- Provides training to stakeholders on compliance requirements
- Applies knowledge of federal, state, and local regulations, as well as university policies and practices, to ensure satisfactory compliance
- May provide back up support to supervisor in supervisors absence
- Performs all other duties as assigned

Job Duties

Job Duty NameJob Specific FunctionsDescription of Job Duty

- Reviews, establishes, and implements policies and procedures for the HRPP
- Ensures compliance with applicable government and institution regulations
- Evaluates protocols, registrations, and studies for completion and potential subject risk and determines appropriate review process
- Provides compliance assistance to investigators and departmental administrations
- Completes congruency reviews for federally funded research that involves human participants
- Prepares reports to the Institutional Official (IO) and various federal agencies
- Updates and maintains protocol databases and records, committee standard operating procedures, and websites
- Provides training for new committee members, investigators, and administrators
- Reviews compliance programs to identify areas in need of improvement
- Updates procedures and policies as needed

System Administration
- Assists in the development, implementation and on-going maintenance of research compliance systems (e.g., protocol database, committee website, and other document repository sites)
- Coordinates databases used to analyze and deliver data
- Ensures systems are compliant and user friendly

Committee Staffing
- Manages the IRB for the Protection of Human Subjects in Research
- Maintains records of each protocol and ensure that records are kept in accordance with federal policy and guidelines as well as Rice policies and procedures
- Acts as the recording secretary for committee meetings (e.g., maintains schedules and issues agendas in advance of the meetings)
- Ensures that for each protocol needing full board or committee review there is a primary and secondary reviewer
- Consults with committee chair about committee membership and assists chair with duties

Program Development and Administration
- Provides direction for the HRPP
- Identifies and accesses needs in areas of improvement and develops programs
- Conducts protocol review/s
- Manages the review process (e.g., annual and off cycle reviews)
- Provides training
- Interacts with the IO and consults with and brings serious compliance matters to the attention of the IO
- Coordinates reports and other communications

Applicant DocumentsRequired Documents
  1. Cover Letter
  2. Resume
Optional Documents
    Supplemental Questions

    Required fields are indicated with an asterisk (*).

    1. * Do you have a bachelor's degree or higher in social science, natural science, or engineering field?
      • Yes
      • No
    2. * Do you have three or more years of related work experience in any of the following: IRB research compliance, research administration and/or working in a regulatory environment with the ability to understand the federal laws, regulations, and procedures pertaining to human subjects research ethics?

      (Open Ended Question)

    3. * Please provide the salary or range that you would require or consider for this position.

      (Open Ended Question)

     

     

     

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    Job No:
    Posted: 9/26/2019
    Application Due: 10/23/2019
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