Clinical Research Regulatory Specialist Details

Clinical Research Regulatory Specialist

Oklahoma Medical Research Foundation - Oklahoma City, OK

Employment Type : Full-Time

Clinical Research Regulatory Specialist
Overview
OMRF is an independent, not-for-profit biomedical research institute adjacent to the University of Oklahoma Health Sciences Center (OUHSC) campus in Oklahoma City. Oklahoma City offers a dynamic and flourishing downtown area, with low cost of living, short commute times and a diversified economy. OMRF's excellence can only be fully realized by individuals who share our commitment to diversity, equity and inclusion. Successful candidates will demonstrate commitment to these values. OMRF is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to gender, sexual orientation, gender identity, race, color, national origin, age, religion, disability, veteran status or any other legally protected characteristic.

Responsibilities
The Arthritis & Clinical Immunology Research Program is hiring for a Clinical Research Regulatory Specialist. This position will provide clinical research operational support through management of IRB, CDAs, MTAs and other regulatory documents.

• IRB Correspondent: Ensure completion of IRB submissions for all trials including the IRB application, protocol, investigators brochure, informed consent form, and HIPAA forms. Manage all other IRB submissions/ correspondence including continuing reviews/renewals, protocol amendments, ICF changes, protocol deviations, advertising approvals, and closure reports. Track and facilitate staff training/certifications pertaining to the IRB and regulatory requirements, particularly CITI, institution-specific training, GCP, and other study-specific training.

• Regulatory Documents Manager: Ensure completion and submission of study start-up regulatory documents including protocol signature pages, 1572s, financial disclosure forms, CVs, and medical licenses. Maintain and update documents and logs as necessary throughout the course of the trials. Track and file all correspondence in study specific regulatory binders. Process and track all IND safety reports.

• Staff Liaison: Collaborate with the study staff and the study sponsor at start up for completion of all required IRB and regulatory documents. Communicate with the investigators, clinical research coordinators, sponsor, and IRB regarding issues, questions, pending tasks, and status updates. Develop and implement processes to collect necessary information for management of IRB correspondence and reporting, i.e. enrollment status for continuing review forms, unanticipated adverse events log.

• As Needed: Performs various duties as needed to successfully fulfill the function of the position.

Qualifications
Bachelor's degreeRelevant experience in regulatory affairs and clinical research or equivalent experience, medical/science background and/or relevant experience, excellent knowledge of all relevant regulations including ICH, GCP, and FDA CFR as applicable.OMRF has mandated the COVID-19 vaccine for all employees, excluding those with an approved medical or religious accommodation, as a condition of employment. Applicants must have received, or be willing to receive, a COVID-19 vaccine by their start date to be considered for employment.

To apply, visit https://careers-omrf.icims.com/jobs/1352/clinical-research-regulatory-specialist/job?in_iframe=1

OMRFs excellence can only be fully realized by individuals who share our commitment to diversity, equity and inclusion. Successful candidates will demonstrate commitment to these values. OMRF is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to gender, sexual orientation, gender identity, race, color, national origin, age, religion, disability, veteran status or any other legally protected characteristic.

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