Lehigh University Research Integrity Specialist in Bethlehem, Pennsylvania

Summary:

The Research Integrity Specialist supports the workflow of two separate committees that provide ethics reviews of research conducted by Lehigh University. The successful candidate will coordinate the functions and activities of the Institutional Review Board and the Institutional Animal Care and Use Committee in the Office of Research Integrity. The Office of Research Integrity assures the University’s compliance with federal and state regulations and institutional policies that govern research with human subjects and animals.

Accountabilities:

  1. Coordinates the workflow for the Office of Research Integrity
  2. Serves as the first point of contact between the Office of Research Integrity and the University community regarding the submission, review and continuing approval of human subjects and vertebrate animal research
  3. Receives all incoming submissions; provides the first step in the review process to preliminarily interpret and apply federal regulations and University policy to applications; conducts analytical preliminary reviews to ensure completeness and general compliance with regulations and institutional policies; serves as an exempt reviewer for the Institutional Review Board, with primary responsibility for completing all exempt reviews per University policy
  4. Communicates proactively with faculty to resolve outstanding issues prior to committee review; applies federal regulations and University policy to the extent required in order to assess the level of review required and coordinates the committee review process, including preparing and distributing meeting agendas, materials, and minutes and review correspondence to investigators
  5. Provides consultation to the University community regarding application submission processes and requirements
  6. Provides limited consultation to the University community regarding federal regulations and University policy; refers inquiries as appropriate to the Senior Research Integrity Specialist or the Director of Research Policy and Compliance
  7. Responsible for Post-Approval Monitoring functions of the Institutional Animal Care and Use Committee and the Institutional Review Board
  8. Under the direction of the Director of Research Policy and Compliance, collaborates with the Senior Research Integrity Specialist to develop and finalize policies and procedures
  9. Follows established Post-Approval Monitoring policies and procedures to implement all activities on behalf of both committees; schedules and conducts review sessions; compiles formal reports on activity and communicate findings to the researchers, committees and Research Integrity staff as appropriate
  10. Make recommendations for maintaining compliance; assist investigators and Research Integrity staff in developing and implementing corrective and preventative action plans, including researching and making recommendations on best practices and federal and sponsor requirements; provide training, consultation, and support to investigators and the committees as necessary to ensure compliance
  11. Collaborate with the Senior Research Integrity Specialist to identify compliance patterns and develop responsive training initiatives that prospectively address common findings through education and outreach
  12. Provides administrative management for the Office of Research Integrity
  13. Establishes and maintains electronic and hard copy records; works collaboratively with the Senior Research Integrity Specialist to ensure federal inspection and audit-readiness
  14. Provides limited technical support for using IRBNet to the University community
  15. Schedules and coordinates meetings; prepares and distributes meeting agendas, materials and minutes
  16. Efficiently responds to and appropriately refers inquiries directed to the Research Integrity Office
  17. Assists the Senior Research Integrity Specialist during federal inspections and audits
  18. Supports the daily activities of the office through other duties as assigned

Qualifications:

  1. Bachelor's Degree or equivalent combination of education and experience
  2. Three to five years related work experience
  3. Experience and knowledge directly related to Institutional Review Board and/or Institutional Animal Care and Use Committee issues and human and/or animal research protections or an equivalent combination of experience and education is required
  4. Excellent communication and interpersonal skills
  5. Solid writing ability and organizational skills
  6. Solid analytical, decision making and problem solving skills
  7. Solid computer skills with experience using word processing and spreadsheet software
  8. Successful completion of standard background checks including but not limited to: social security verification, education verification, county and national criminal background checks, PATCH, FBI fingerprinting, Child Abuse Clearance. Based upon the requirements of the position Lehigh may also request credit history reports, motor vehicle checks and professional license/certification verification

Special Considerations:

  • Periods of high volume/workload may be required to meet deadlines

Position Number: S98700

Title: Research Integrity Specialist

Department: Office of Research Integrity

Category: Professional/Managerial

Job Family: Research Administration

Website: https://research.cc.lehigh.edu/research-integrity

Posting Date: 04/17/2018

FTE: 100%

Grade and Hiring Minimum: 8-40 Salary commensurate with experience and qualifications. Salary adjustments for internal candidates comply with University policy. For more information contact Human Resources.

Required Documents Message: Cover Letter, Resume