Regulatory Assistant
Regulatory Assistant
Posted on :
22-07-2025
Employer Active
1 Vacancy
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Monthly Salary
$ 47660 - 52000
Vacancy
1 Vacancy
Posted on :
22-07-2025
Job Description
Position Summary
The purpose of this position is to facilitate the conduct of oncology clinical trials by providing regulatory document support to ensure compliance with federal regulations Good Clinical Practice and local and institutional policies. In particular this position is responsible for: Regulatory Essential Document Collection and Regulatory Binder Maintenance * Preparing collecting and obtaining signatures for essential documents for electronic regulatory binder including delegation of authority/delegation of task log financial disclosure forms Form FDA 1572 training documentation protocol signature page IB acknowledgments lab certifications medical licenses CVs * Maintaining regulatory binder including naming regulatory documents in accordance with defined nomenclature filing regulatory documents in eRegulatory binder in accordance with defined filing structure * Communicating with sponsors and monitors regarding status of essential regulatory documents and providing essential documents as required * Tracking and recording pending regulatory actions through completion on study team trackers * Providing updates on status of pending regulatory actions at study team meetings (oral and/or written) and takes meeting minutes * Accurately entering IRB approval information into the electronic clinical research management system (OnCore) and uploading study documents into OnCore within required deadlines * Other duties as assigned Monitoring and Auditing Compliance * Preparing regulatory binder for monitoring and audit visits and addresses regulatory findings within required deadlines. Portfolio Management: Regulatory IRB Applications * Preparing submitting and processing in a timely and accurate manner IRB applications for: o continuing reviews for closed to accrual studies with all patients off treatment to the IRB of record o personnel modifications to UNC IRB o external IND safety reports to UNC IRB This position may include involvement in process improvements: * Developing writing and providing input on standard operating procedures work instructions and internal processes. * Mentoring new Regulatory team members * Participating on CTO committees/task forces/working groups * Assisting in training Regulatory team members as needed * Attending pre-study team regulatory meetings for assigned study teams These responsibilities relate to the UNC / LCCC Clinical Research mission by maintaining the quality of research and by addressing patient safety and regulatory compliance which impact on research quality and safeguarding institutional integrity.
Required Qualifications Competencies And Experience
High level of accuracy and attention to detail. Solid writing skills. Demonstrated ability to organize and present information. Demonstrated ability to plan work to meet objectives and deadlines. Demonstrated ability to communicate effectively and professionally verbally and in writing. Strong computer skills including working knowledge and facility with Outlook Word Excel and PowerPoint. Ability to work on evenings weekends and/or holidays occasionally required. A cover letter is required as an example of professional written communication skills.
Preferred Qualifications Competencies And Experience
Experience in regulatory binder maintenance for FDA -regulated clinical research studies. Experience in clinical research including knowledge of 21 CFR Partsand ICH GCP Guidelines. Experience using an eRegulatory system (such as Florence) and a clinical trials management system (such as OnCore).
Work Schedule
Monday Friday 8am-5pm Flexible work arrangements including remote/hybrid work locations are an integral part of the School of Medicines Working Forward initiative. As such this positions work location is designated as virtual. Please note that the designated work location is subject to change based on the units business needs.
The purpose of this position is to facilitate the conduct of oncology clinical trials by providing regulatory document support to ensure compliance with federal regulations Good Clinical Practice and local and institutional policies. In particular this position is responsible for: Regulatory Essential Document Collection and Regulatory Binder Maintenance * Preparing collecting and obtaining signatures for essential documents for electronic regulatory binder including delegation of authority/delegation of task log financial disclosure forms Form FDA 1572 training documentation protocol signature page IB acknowledgments lab certifications medical licenses CVs * Maintaining regulatory binder including naming regulatory documents in accordance with defined nomenclature filing regulatory documents in eRegulatory binder in accordance with defined filing structure * Communicating with sponsors and monitors regarding status of essential regulatory documents and providing essential documents as required * Tracking and recording pending regulatory actions through completion on study team trackers * Providing updates on status of pending regulatory actions at study team meetings (oral and/or written) and takes meeting minutes * Accurately entering IRB approval information into the electronic clinical research management system (OnCore) and uploading study documents into OnCore within required deadlines * Other duties as assigned Monitoring and Auditing Compliance * Preparing regulatory binder for monitoring and audit visits and addresses regulatory findings within required deadlines. Portfolio Management: Regulatory IRB Applications * Preparing submitting and processing in a timely and accurate manner IRB applications for: o continuing reviews for closed to accrual studies with all patients off treatment to the IRB of record o personnel modifications to UNC IRB o external IND safety reports to UNC IRB This position may include involvement in process improvements: * Developing writing and providing input on standard operating procedures work instructions and internal processes. * Mentoring new Regulatory team members * Participating on CTO committees/task forces/working groups * Assisting in training Regulatory team members as needed * Attending pre-study team regulatory meetings for assigned study teams These responsibilities relate to the UNC / LCCC Clinical Research mission by maintaining the quality of research and by addressing patient safety and regulatory compliance which impact on research quality and safeguarding institutional integrity.
Required Qualifications Competencies And Experience
High level of accuracy and attention to detail. Solid writing skills. Demonstrated ability to organize and present information. Demonstrated ability to plan work to meet objectives and deadlines. Demonstrated ability to communicate effectively and professionally verbally and in writing. Strong computer skills including working knowledge and facility with Outlook Word Excel and PowerPoint. Ability to work on evenings weekends and/or holidays occasionally required. A cover letter is required as an example of professional written communication skills.
Preferred Qualifications Competencies And Experience
Experience in regulatory binder maintenance for FDA -regulated clinical research studies. Experience in clinical research including knowledge of 21 CFR Partsand ICH GCP Guidelines. Experience using an eRegulatory system (such as Florence) and a clinical trials management system (such as OnCore).
Work Schedule
Monday Friday 8am-5pm Flexible work arrangements including remote/hybrid work locations are an integral part of the School of Medicines Working Forward initiative. As such this positions work location is designated as virtual. Please note that the designated work location is subject to change based on the units business needs.
Required Experience:
Staff IC
Employment Type
Full-Time
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