• Job Description

  Req#: R90408

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  Job Title:

  Research Compliance Analyst

  Department:

  Health Sciences | Center for Clinical and Translational Sciences

  The Research Compliance Analyst works within the Center for Clinical and Translational Science (CCTS) Regulatory Program Core and reports to the CCTS Regulatory Program Manager. They serve as a resource to promote compliant and ethical research practices across the University’s colleges. This position will work cross-functionally with a multitude of researchers and departments across the University.

  Primary responsibilities for this position include developing and providing tools and resources for successful ClinicalTrials.gov (CT.gov) registration and results reporting. These resources may include independently developing, managing, and presenting trainings and completing one-on-one consults with the CT.gov responsible parties and record owners. This position will also communicate ClincialTrials.gov compliance statuses to OSU Sr. Leadership and the University College’s Associate Deans for Research. Under the supervision of the CCTS Regulatory Program Manager, and through significant cross-functional collaboration, this position will provide services to build upon established university processes to help ensure university regulatory compliance with CT.gov.

  Other primary responsibilities for this position are to coordinate the day-to-day project and administrative activities for the CCTS core service voucher support program and to manage CCTS publication tracking. This includes data collection and entry and utilizing effective and clear communication techniques.

  Additional responsibilities include assisting with coordinating, reviewing, and providing administrative support for clinical research related data and safety monitoring, regulatory related meetings, trainings, and consults. Assisting with providing regulatory related guidance, tools, and templates to researchers of interventional, socio-behavioral, and technological related clinical research. Regulatory guidance may include FDA IND or IDE submissions, IRB submissions, and essential document creation. This role will research and identify current trends, topics, and updates to research related regulations and effectively communicate these changes to researchers. This position will assist the Regulatory Program Manager with developing novel regulatory pathways, models and templates, for new innovative medical products and may assist with prior approval submissions of research vouchers and research protocols to NIH-NCATS. This role will develop and partake in cross-functional collaborations both internally and externally which requires strong communication and documentation skills.

  Additional Information:

  Function: Research Administration

  Sub Function: Research Compliance

  Career Band: S

  Career Level:S2

  This position offers a hybrid work environment opportunity, working both on site and remotely.

  Required Qualifications

  Bachelor’s Degree in a biological science, life science field, health sciences, social sciences or other relevant field, or equivalent experience. Two years experience working on clinical research projects ; knowledge of good clinical practice guidelines and clinical research regulatory rules, policies, and processes.

  Additional Desired Qualifications

  Research related certification through either SOCRA, ACRP, RAPS, PRIM&R desired.

  Location:

  Prior Hall (0302)

  Position Type:

  Regular

  Scheduled Hours:

  40

  Shift:

  First Shift

  Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.

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  The Ohio State University is an equal opportunity employer.

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  Applicants are encouraged to complete and submit the Equal Employment Identification form.

• About the company

  The Ohio State University, commonly Ohio State or OSU, is a public land-grant research university in Columbus, Ohio.

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