Senior Regulatory Coordinator
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Description:
Specific Responsibilities:
• Determines and interprets applicable rules and regulations associated with clinical research studies and trials involving human subjects ensuring the protection of their safety, rights, and welfare.
• Guides and coordinates all associated submission, documentation, and reporting processes (new study applications, renewals, revisions, modifications, amendments, adverse events, safety reports, close-out, etc.) some of which may be very complex in nature, recommending alternatives to ensure compliance and approval.
• Acts as liaison between research staff (PI, faculty, nurses, technicians, etc.), and internal/external regulatory and oversight groups (NU’s IRB, sponsors (NIH, industry), government agencies (FDA), etc.) to resolve issues and problems, negotiate compromises, and offer alternatives and recommendations to facilitate and expedite research while ensuring compliance.
• Assists junior staff in resolving such issues and problems.
• Determines compliance required documentation and develops necessary items such as protocols, informed consent, etc.
• Ensures accuracy of IRB approval letters with respect to sponsor information and NIH grant identifiers.
• Provides guidance and training to junior staff and research staff to ensure compliance with complex, highly specialized rules and regulations associated with clinical research studies and trials involving human subjects.
• Creates reports, summaries and analysis in regard to compliance requirements recommending changes in practice or procedure to increase effectiveness and efficiency of compliance.
• Researches new and updated rules and regulations associated with clinical research studies and trials involving human subjects.
• Alerts appropriate staff to changes and ensures appropriate interpretation and application to new and existing studies and trials.
• Serves as a resource to the clinical research office staff on regulatory concepts.
• Performs other duties as assigned.
Skills:
Regulatory, Irb, Clinical research, Oncology, Gcp, Regulatory documents, Fda, Crf, Regulatory affairs, Clinical trial, Regulatory submission, Ctms, Contract, Audit
Top Skills Details:
Regulatory,Irb,Clinical research,Oncology,Gcp,Regulatory documents,Fda,Crf,Regulatory affairs,Clinical trial,Regulatory submission,Ctms,Contract,Audit
Additional Skills & Qualifications:
Strong regulatory knowledge including familiarity with Code of Federal Regulations and Good Clinical Practice guidelines. • Strong communication, writing, and interpersonal skills. • Computer literacy in word processing, database use, and file management
Experience Level:
Expert Level
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.