The Ohio State University
Regulatory Compliance Officer
The Ohio State University, Columbus, Ohio, United States, 43224
Overview
Job Title: Regulatory Compliance Officer Department: Medicine | Clinical Trials Management Office Regulatory Compliance Officer who provides regulatory expertise to assure research protocols are in compliance with university, state and federal regulations across research groups managed by the College of Medicine Center for Clinical Research Management (CCRM); participates in development and implementation of strategies, policies and procedures to ensure proposals meet or exceed federal, state and local regulations; develops and prepares protocol submissions to local and national Institutional Review Boards (IRB), including writing of abstract, submission of standard forms and drafting of informed consent form; collaborates with investigators during study development to facilitate and confirm that appropriate regulatory safeguards have been included; conducts detailed reviews of assigned protocols and informed consent forms prior to IRB review; ensures timely submission of protocol documents for review by appropriate agency; communicates with sponsors of any research project (industry, federal, collaborative, investigator-initiated) to address concerns and assure compliance; establishes and oversees tracking system to continually monitor progress of protocol review and status of approval; reviews and authorizes protocol revisions and amendments; amends consent forms as needed and follows established guidelines from OSU and NIH (National Institutes of Health) to determine if amendment requires IRB review; distributes amendments and IRB approved informed consent forms to relevant university protocol holders; continually monitors federal and sponsor rules, regulations and processes to identify and interpret new, updated or changed requirements; provides regulatory updates to investigators and research staff of new or changed regulations; participates in audits and site visits. Minimum Education Required
Bachelor's Level Degree or equivalent combination of education and experience. Required Qualifications
2 years of relevant experience in a clinical research or administrative capacity working on clinical research projects required; considerable knowledge of clinical research regulations and compliance issues especially related to the use of human and animal subjects required. Desired Qualifications
2-4 years of relevant experience preferred. Experience and knowledge of federal and industry research sponsor requirements preferred; experience in a regulatory affairs capacity in a medical research setting desired; experience in protocol development desired. Requires successful completion of a background check. Selected candidate may be requested to complete a pre-employment physical including a drug screen. FUNCTION/SUBFUNCTION: Research Administration/Research Compliance CAREER BAND: Individual Contributor- Specialized CAREER LEVEL: S2 Additional Information
This position is primarily remote; however, there may be times when being onsite may be required. Location: Davis Heart and Lung Research Institute (0113) 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. Thank you for your interest in positions at The Ohio State University and Wexner Medical Center. Once you have applied, the most updated information on the status of your application can be found by visiting the Candidate Home section of this site. Please view your submitted applications by logging in and reviewing your status. For answers to additional questions please review the frequently asked questions. The university is an equal opportunity employer, including veterans and disability. As required by Ohio Revised Code section 3345.0216, Ohio State will: educate students by means of free, open and rigorous intellectual inquiry to seek the truth; equip students with the opportunity to develop intellectual skills to reach their own, informed conclusions; not require, favor, disfavor or prohibit speech or lawful assembly; create a community dedicated to an ethic of civil and free inquiry, which respects the autonomy of each member, supports individual capacities for growth and tolerates differences in opinion; treat all faculty, staff and students as individuals, hold them to equal standards and provide equality of opportunity with regard to race, ethnicity, religion, sex, sexual orientation, gender identity or gender expression. #J-18808-Ljbffr
Job Title: Regulatory Compliance Officer Department: Medicine | Clinical Trials Management Office Regulatory Compliance Officer who provides regulatory expertise to assure research protocols are in compliance with university, state and federal regulations across research groups managed by the College of Medicine Center for Clinical Research Management (CCRM); participates in development and implementation of strategies, policies and procedures to ensure proposals meet or exceed federal, state and local regulations; develops and prepares protocol submissions to local and national Institutional Review Boards (IRB), including writing of abstract, submission of standard forms and drafting of informed consent form; collaborates with investigators during study development to facilitate and confirm that appropriate regulatory safeguards have been included; conducts detailed reviews of assigned protocols and informed consent forms prior to IRB review; ensures timely submission of protocol documents for review by appropriate agency; communicates with sponsors of any research project (industry, federal, collaborative, investigator-initiated) to address concerns and assure compliance; establishes and oversees tracking system to continually monitor progress of protocol review and status of approval; reviews and authorizes protocol revisions and amendments; amends consent forms as needed and follows established guidelines from OSU and NIH (National Institutes of Health) to determine if amendment requires IRB review; distributes amendments and IRB approved informed consent forms to relevant university protocol holders; continually monitors federal and sponsor rules, regulations and processes to identify and interpret new, updated or changed requirements; provides regulatory updates to investigators and research staff of new or changed regulations; participates in audits and site visits. Minimum Education Required
Bachelor's Level Degree or equivalent combination of education and experience. Required Qualifications
2 years of relevant experience in a clinical research or administrative capacity working on clinical research projects required; considerable knowledge of clinical research regulations and compliance issues especially related to the use of human and animal subjects required. Desired Qualifications
2-4 years of relevant experience preferred. Experience and knowledge of federal and industry research sponsor requirements preferred; experience in a regulatory affairs capacity in a medical research setting desired; experience in protocol development desired. Requires successful completion of a background check. Selected candidate may be requested to complete a pre-employment physical including a drug screen. FUNCTION/SUBFUNCTION: Research Administration/Research Compliance CAREER BAND: Individual Contributor- Specialized CAREER LEVEL: S2 Additional Information
This position is primarily remote; however, there may be times when being onsite may be required. Location: Davis Heart and Lung Research Institute (0113) 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. Thank you for your interest in positions at The Ohio State University and Wexner Medical Center. Once you have applied, the most updated information on the status of your application can be found by visiting the Candidate Home section of this site. Please view your submitted applications by logging in and reviewing your status. For answers to additional questions please review the frequently asked questions. The university is an equal opportunity employer, including veterans and disability. As required by Ohio Revised Code section 3345.0216, Ohio State will: educate students by means of free, open and rigorous intellectual inquiry to seek the truth; equip students with the opportunity to develop intellectual skills to reach their own, informed conclusions; not require, favor, disfavor or prohibit speech or lawful assembly; create a community dedicated to an ethic of civil and free inquiry, which respects the autonomy of each member, supports individual capacities for growth and tolerates differences in opinion; treat all faculty, staff and students as individuals, hold them to equal standards and provide equality of opportunity with regard to race, ethnicity, religion, sex, sexual orientation, gender identity or gender expression. #J-18808-Ljbffr