Clinical Research Assistant II Regulatory - Medicine Clinical Trials Office
Clinical Research Assistant II Regulatory - Medicine Clinical Trials Office
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Salary Not Disclosed
1 Vacancy
Job Description
The Regulatory Assistant II plays a vital role in supporting clinical research compliance by managing and maintaining electronic regulatory binders. This position ensures that all regulatory documentation is accurate current and audit-ready while collaborating closely with regulatory affairs teams to uphold institutional and federal standards.
Maintaining regulatory compliance in clinical trials is essential for safeguarding patient safety upholding ethical standards ensuring data integrity and facilitating the development and approval of new medical treatments and technologies. This position offers an opportunity to play a critical role in ensuring regulatory compliance and document management within a dynamic and fast-paced environment. The successful candidate will have the chance to work closely with regulatory affairs professionals and gain valuable experience in the pharmaceutical or healthcare
Responsibilities
Electronic Binder Management:
- Assist with all aspects of clinical research regulatory compliance including document preparation submission and management for clinical trials.
- Organize and maintain electronic regulatory binders in accordance with established procedures.
- Ensure proper version control and document naming conventions are followed.
- Implement and maintain an efficient filing structure for easy navigation and retrieval of documents.
- Obtains and maintains required regulatory documentation and study specific regulatory binders for all studies.
Document Collection and Review:
- Collaborate with regulatory affairs team to collect required documents for inclusion in electronic binders.
- Review documents for completeness accuracy and compliance with regulatory standards.
- Identify and rectify any errors or inconsistencies promptly.
- Coordinate with stakeholders to address any discrepancies or missing information.
- Assist team to ensure all site documents including SOPs and administrative files are maintained in audit-ready condition.
- Assist to complete required forms specific to each protocol.
- Assists with the maintenance of regulatory data in the clinical trial management system (OnCore).
- Revise submissions in response to identified problems and resolve issues in a timely manner; inform clinical research team on revisions and remedies.
- Ensure all regulatory documents are readily accessible and organized for inspection purposes.
Other Responsibilities:
- Participate in required teleconferences on-site meetings as required.
- Performs all other related duties as assigned.
- Prepare for study monitoring and auditing visits with study coordinator investigator industry sponsors and internal/external auditors.
- Maintain working knowledge of current regulations regulatory guidance and or local policies.
Qualifications
- Associates Degree in related field or HS Diploma with equivalent related experience
- Bachelors degree preferred
- 1 year of research experience; preferably in a multi-site trial setting
- Creative problem solving skills; ability to navigate through ambiguous situations
- Strong organizational communication and interpersonal skills
- Ability to manage competing priorities and deadlines in a fast paced environment
- Proficiency with MS 365 office suite
Employment Type
Full-Time
