Research Regulatory Coordinator

About the Role

Day-to-day responsibilities will include preparing regulatory submissions, maintaining master regulatory files, and coordinating with study team members to perform these duties. The ideal candidate will have a working knowledge of all facets of the role, relevant regulations, and organizational and departmental policies and procedures.

What You Will Do

• Collaborate with the PI’s and internal and external members of the clinical research team within the scope of clinical trial regulatory submission and compliance.
• Assist in preparing regulatory submissions and maintaining the regulatory files.
• Coordinate the preparation of regulatory documents for submission to the Institutional Review Board (IRB) or other IRB’s as determined.
• Prepare and submit initial documents, continuing reports, amendments, and addendums to research protocols and consent documents.
• Assist in maintaining master regulatory files in accordance with institutional, state, and federal regulations.
• Demonstrate working knowledge of all facets of the role, relevant regulations, and organizational and departmental policies and procedures.
• Perform other duties and projects as assigned.
• Ensure all duties are performed in accordance with regulatory requirements and organizational policies and procedures.

What We Are Looking For

• Experience working with clinical trials, preferably in an oncology setting.
• Strong knowledge of federal regulations, ICH, and GCP guidelines.
• Ability to work collaboratively with various stakeholders, including principal investigators and study team members.
• Excellent organizational and time management skills, with attention to detail.
• Proficiency in Microsoft Office, particularly Excel.
• Understanding of the importance of maintaining confidentiality and security of patient records in compliance with HIPAA.
• High school diploma or equivalent required; bachelor’s degree preferred.

Nice to Have

• Certification in clinical research or a related field.
• Experience with electronic document systems and regulatory binders.
• Knowledge of ALCOAC method for maintaining credible documentation.

Benefits and Perks

• Competitive salary and benefits package.
• Opportunity to work remotely and contribute to the advancement of cancer care.
• Professional development opportunities in a dynamic and growing field.
• Access to the latest technologies and tools in clinical research.
• Comprehensive health insurance and retirement plan.
• Generous paid time off and holidays.

• Ensure your resume and cover letter highlight any experience with regulatory compliance, clinical trials, and document management.
• Familiarize yourself with the latest federal regulations and guidelines affecting clinical research, such as those from the FDA and ICH.
• Prepare examples of times when you had to maintain detailed records or ensure compliance with specific regulations.
• Practice explaining complex regulatory concepts in simple terms, as this will be valuable in your interactions with cross-functional teams.
• Consider obtaining certifications in clinical research to enhance your application and demonstrate your commitment to the field.
• Be prepared to discuss how you handle confidential and sensitive information, given the nature of working with patient records and clinical trial data.