[Hiring] Regulatory Audit Coordinator @COG Research Foundation, LLC

Role Description

All staff are employed through the Research Foundation. This role will be in service to COG.

The primary responsibility for the Regulatory Audit Coordinator is to conduct the regulatory component of COG audits for all COG institutions as defined in the NCI’s Clinical Trials Monitoring Branch (CTMB) guidelines. This requires diligent review of IRB submission and review of institutional informed consent documents to ensure compliance with the COG template and appropriate policies.

Additionally, the Regulatory Audit Coordinator is responsible for receipt and review of submitted regulatory documents for compliance with federal regulations and COG policies by reviewing regulatory document submissions for fully industry funded COG studies, as well as review of protocol deviation forms submitted in Medidata Rave and early closure forms from sites.

The COG Research Foundation, LLC is a 100% remote employer, though some travel may be required. Employee must reside within the United States.

Full salary range for this position: $70,296 to $101,911 per year. The typical hiring range for this position is from $70,296 (minimum) to $86,104 (midpoint), based on 100% FTE. The starting salary is determined based on the candidate’s knowledge, skills, experience, as well as budget availability.

Qualifications

• Two (2) years experience as a Clinical Regulatory Coordinator, Clinical Trial Auditor, Clinical Trial Monitor or other relevant human clinical trials research experience that includes direct knowledge of FDA Regulations and ICH Guidelines.
• Bachelor’s degree in biology, chemistry, biochemistry, physiology, nursing, or related field, or substitute with four additional years of related experience.
• Ability to analyze clinical trial protocols, consent forms and protocol deviation submissions to identify compliance issues.
• Experience with oncology clinical trials.
• Must have knowledge of clinical trial related FDA regulations, ICH-GCP Guidelines.
• High attention to detail and accuracy in document review, data entry, and query resolution.
• Strong organizational skills with the ability to manage multiple regulatory submissions and deadlines simultaneously.
• Ability to work on a team and independently.
• Excellent verbal and written communication skills.
• Ability to maintain confidentiality of sensitive study and participant information.
• Microsoft Office suite and applicable software program(s) proficiency.
• Ability to travel to COG Group Meetings and any other business-related meetings.

Requirements

• Oversee the intake and review of protocol deviation forms in accordance with protocol requirements and internal SOPs.
• Request Corrective and Preventive Actions (CAPAs) from sites consistent with COG policy.
• Evaluate early closure requests and serve as the primary regulatory contact for site inquiries regarding early closure requests.
• Provide input on site-facing communications regarding required regulatory documents, consistent with COG policy and federal regulations.
• Coordinate site registration status changes, ensuring alignment with protocol milestones and federal compliance metrics.
• Develop and maintain SOPs, templates and guidance documents for work processes.
• Perform other duties as assigned.

Benefits

• Comprehensive benefit options include medical, dental, vision, 401(k), accrued Paid Time Off (PTO), Employee Assistance Program (EAP), Flexible Spending Account (FSA), cell phone and internet stipends, wellness stipend, paid holidays, and more.
• Employees who work 20 hours or more per week are eligible for these benefit options.