Clinical Research Regulatory Specialist

Job Summary:

The Regulatory Coordinator is responsible for overseeing the day-to-day regulatory management of all types of clinical research protocols. The position will manage all aspects of study start-up, modification submissions, continuous reporting, and study close-out to the Institutional Review Board (IRB) and any relevant regulatory agencies including, the Institutional Biosafety Committee, the institutional Radiation Safety Committee, and the clinical trial sponsor, funding foundation, or governmental agency.

Essential Functions & Responsibilities:

Duties include but not limited to:

• Manage day-to-day regulatory operations and workload of regulatory team, plan resource needs and strategize growth.
• Provide regulatory support for research programs and oversee maintenance of all required regulatory documents.
• Provide regulatory start-up support for research teams for all types of clinical trials.
• Partner with study teams to provide ad hoc regulatory management for ongoing clinical trials.
• Oversee timely regulatory submissions to meet project timelines.
• Create and maintain position related Standard Operating Procedures (SOPs) and ensures procedural compliance.
• Identify program improvement opportunities and lead improvement efforts within team, including technology solutions; identify opportunities for expanding solutions to study teams.
• Coordinate with appropriate department to address regulatory-related quality and compliance matters.
• Assist with the development of standard regulatory-related training requirements and with ongoing education and training for investigators and research personnel.
• Perform internal audits and quality assurance reviews on regulatory files, as needed
• Write and edit clinical research protocol consent forms in accordance with federal regulations and guidelines and good clinical practice (GCP) guidelines.
• Liaise with appropriate personnel, departments and outside entities on clinical trial regulatory operations.
• Must understand clinical trial and research regulatory processes.
• Able to prioritize work and work with departments and study teams over a variety of projects.
• Able to exercise good judgment on a range of issues and to manage overlapping and complex projects through to completion.

Qualifications:

• Must have excellent interpersonal and communication skills as well as organizational and writing skills.
• Have at least 2 years Regulatory experience (Preferred) 
• Must be adept at computer usage including knowledge of word processing and data base software with an ability to learn various project databases.
• Must have experience with electronic health record systems and clinical trial management systems.

Benefits:

• Full-time employees are benefits-eligible for Medical, Dental, Vision, Life insurance, Short-term and Long-term disability insurances are offered.
• 401k plan
• PTO accruals