University of Louisville
Research Regulatory Coordinator IV
University of Louisville, Louisville, Kentucky, us, 40201
Department:
Location:Health Sciences CenterTime Type:Full timeWorker Type:RegularJob Req ID:R105966Minimum Requirements:Bachelor's degree in Science, Business or a related field and two (2) years of regulatory work related on interpretation of federal and local regulations or an equivalent combination of education and experience. Grade 4 (Hourly)Position Description:
The Clinical Trials Program of the Brown Cancer Center is seeking a Research Regulatory Coordinator IV to provide regulatory support and oversight to clinical trials at the University of Louisville. This position is responsible for preparing research submissions to the IRB of record, maintenance of regulatory approvals and documentation, and providing regulatory guidance to the clinical and administrative staff of the Clinical Trials Program in a manner that demonstrates understanding and application of the federal regulations governing human subjects in research (i.e. 45 CFR 46, 21 CFR 50, 56, 312, 812, ICH GCP, and HIPAA).
Essential Duties and Responsibilities:
This position will provide regulatory oversight and management of human subject clinical trials for the entire project period to ensure compliance with all applicable regulations, policies and procedures as follows:Serve as primary regulatory contact with the sponsoring agency for regulatory approvals throughout the life of the project. Serve as primary regulatory contact to the University of Louisville IRB or other IRB of record for the clinical trial.
Evaluate the protocol and sponsor documents such as lab and imaging manuals, case reports, consent forms, FDA correspondence to determine if additional items are needed for IRB/Sponsor approval.
Develop site specific regulatory and other essential documents in compliance with the protocol and federal/local and affiliated healthcare provider requirements. Prepare consent and HIPAA documents with appropriate language for industry sponsor, facility, and IRB approval.
Complete the electronic IRB submission, prepare IRB modifications based on analysis of contingencies presented by the committee or the study team, process sponsor requested changes and modify regulatory documents accordingly, manage essential documents in accordance with the sponsor, IRB and federal government requirements.
Submit amendment and continuing review data on behalf of the Principal Investigator, investigate study irregularities and guide staff in reporting and documentation of events. Submit studies for closure and resolve any outstanding relevant findings with the sponsor or study team.
Participate in study planning meetings, site initiation visits, monitoring visits and audits conducted by clinical trial sponsors, FDA, and IRB.
Educate and provide guidance for documentation and processes to clinical trial site staff and investigators on matters of regulatory compliance, University policy, and Good Clinical Practice as relates clinical research conduct.
Participate in internal quality audits, quality improvement projects, protocol specific corrective and preventative action plans, and compliance reviews for the Clinical Trials Program.
Preferred Qualifications:
Certification from Society of Clinical Research Associates.
The Brown Cancer Center encourages candidates to apply who have demonstrated capacity to create inclusive work environments, will work effectively on increasingly diverse teams, and will serve the increasingly diverse students we admit and want to attract.
Target Compensation Maximum:$31.38Target Compensation Minimum:$20.92Compensation will be commensurate to candidate experience.
Equal Employment Opportunity
The University of Louisville is an equal opportunity, affirmative action employer, and is committed to providing employment opportunities to all qualified applicants without regard to race, sex, age, color, national origin, ethnicity, creed, religion, disability, genetic information, sexual orientation, gender, gender identity and expression, marital status, pregnancy, or veteran status. If you are unable to use our online application process due to an impairment or disability, please contact the Employment team at employment@louisville.edu or 502.852.6258.
Assistance and
Accommodations
Computers are available for application submission at the Human Resources Department located at 215 Central Avenue, Ste 205 - Louisville, Kentucky 40208.
If you require assistance or accommodation with our online application process, please contact us by email at employment@louisville.edu or by phone 502-852-6258.
Location:Health Sciences CenterTime Type:Full timeWorker Type:RegularJob Req ID:R105966Minimum Requirements:Bachelor's degree in Science, Business or a related field and two (2) years of regulatory work related on interpretation of federal and local regulations or an equivalent combination of education and experience. Grade 4 (Hourly)Position Description:
The Clinical Trials Program of the Brown Cancer Center is seeking a Research Regulatory Coordinator IV to provide regulatory support and oversight to clinical trials at the University of Louisville. This position is responsible for preparing research submissions to the IRB of record, maintenance of regulatory approvals and documentation, and providing regulatory guidance to the clinical and administrative staff of the Clinical Trials Program in a manner that demonstrates understanding and application of the federal regulations governing human subjects in research (i.e. 45 CFR 46, 21 CFR 50, 56, 312, 812, ICH GCP, and HIPAA).
Essential Duties and Responsibilities:
This position will provide regulatory oversight and management of human subject clinical trials for the entire project period to ensure compliance with all applicable regulations, policies and procedures as follows:Serve as primary regulatory contact with the sponsoring agency for regulatory approvals throughout the life of the project. Serve as primary regulatory contact to the University of Louisville IRB or other IRB of record for the clinical trial.
Evaluate the protocol and sponsor documents such as lab and imaging manuals, case reports, consent forms, FDA correspondence to determine if additional items are needed for IRB/Sponsor approval.
Develop site specific regulatory and other essential documents in compliance with the protocol and federal/local and affiliated healthcare provider requirements. Prepare consent and HIPAA documents with appropriate language for industry sponsor, facility, and IRB approval.
Complete the electronic IRB submission, prepare IRB modifications based on analysis of contingencies presented by the committee or the study team, process sponsor requested changes and modify regulatory documents accordingly, manage essential documents in accordance with the sponsor, IRB and federal government requirements.
Submit amendment and continuing review data on behalf of the Principal Investigator, investigate study irregularities and guide staff in reporting and documentation of events. Submit studies for closure and resolve any outstanding relevant findings with the sponsor or study team.
Participate in study planning meetings, site initiation visits, monitoring visits and audits conducted by clinical trial sponsors, FDA, and IRB.
Educate and provide guidance for documentation and processes to clinical trial site staff and investigators on matters of regulatory compliance, University policy, and Good Clinical Practice as relates clinical research conduct.
Participate in internal quality audits, quality improvement projects, protocol specific corrective and preventative action plans, and compliance reviews for the Clinical Trials Program.
Preferred Qualifications:
Certification from Society of Clinical Research Associates.
The Brown Cancer Center encourages candidates to apply who have demonstrated capacity to create inclusive work environments, will work effectively on increasingly diverse teams, and will serve the increasingly diverse students we admit and want to attract.
Target Compensation Maximum:$31.38Target Compensation Minimum:$20.92Compensation will be commensurate to candidate experience.
Equal Employment Opportunity
The University of Louisville is an equal opportunity, affirmative action employer, and is committed to providing employment opportunities to all qualified applicants without regard to race, sex, age, color, national origin, ethnicity, creed, religion, disability, genetic information, sexual orientation, gender, gender identity and expression, marital status, pregnancy, or veteran status. If you are unable to use our online application process due to an impairment or disability, please contact the Employment team at employment@louisville.edu or 502.852.6258.
Assistance and
Accommodations
Computers are available for application submission at the Human Resources Department located at 215 Central Avenue, Ste 205 - Louisville, Kentucky 40208.
If you require assistance or accommodation with our online application process, please contact us by email at employment@louisville.edu or by phone 502-852-6258.