Clinical Regulatory Specialist

About Sarasota Arthritis Center

We are a people focused organization that values compassion, accountability and integrity. We are dedicated to the patients we provide care for as well as the employees who make our practice so successful.

About the role

• We are seeking a highly motivated and detail-oriented Regulatory Specialist for Research to join our team. The successful candidate will play a key role in ensuring that our research activities comply with all relevant regulations and guidelines. This position requires a thorough understanding of regulatory requirements, excellent organizational skills, and the ability to work effectively with cross-functional teams. 

What you'll do

• Independently develops and submits Study Institutional Review Board (IRB) documents such as consent forms and protocols for initial submissions, protocol amendments, and continuing reviews. 
• Independently maintains appropriate study documentation including regulatory binders and enrollment logs. 
• Responsible for preparing, maintaining and updating regulatory binders for review by internal or external monitoring/auditing groups; available to auditors and monitors to discuss regulatory issues at each visit; able to explain internal regulatory processes and Standard Operating Procedures (SOPs) as needed. 
• Submits Adverse Event Reports and Protocol Deviations according to institutional review board and sponsor-specific reporting requirements. 
• Assesses current departmental processes and SOPs; provides suggestions for improvement. 
• Enters protocol specific data into required IRB and Realtime – CTMS software. 
• Assists research team members in assessing and optimizing departmental workflows. 
• Assists in training/mentoring new staff, providing constructive feedback to other team members as necessary. 
• Maintains understanding of the professional guidelines and code of ethics related to clinical research conduct and maintains ability to summarize and clarify these for study teams. 
• Maintains study compliance with Institutional Review Board, Sponsors and other policies. 
• Oversees the maintenance and delegation of authority logs and documentation of training of key personnel on assigned studies. 
• Communicates clearly and in a professional manner with study teams, sponsors and IRB including timely communication when revisions or changes have been approved. 
• Recognizes when others need to be included in conversations and escalates appropriately. 
• Participate in regulatory audits and inspections and assist with the preparation of responses to regulatory agencies. 
• Works closely with sponsors and study teams on the preparation of regulatory documents and addressing relevant regulatory issues. 
• Regularly participates in departmental meetings to discuss the regulatory status of assigned protocols. 

Qualifications

• Bachelor’s degree in a relevant field (e.g., life sciences, regulatory affairs, or related discipline), relevant certifications a plus, minimum high school diploma or equivalent required. 
• Minimum of 3-5 years of experience in regulatory affairs, preferably within a research or academic setting. 
• Strong knowledge of regulatory requirements and guidelines for research activities. 
• Excellent organizational and time-management skills, with the ability to handle multiple tasks and deadlines. 
• Strong attention to detail and accuracy in documentation. 
• Effective communication and interpersonal skills, with the ability to work collaboratively with cross-functional teams. 
• Proficiency in Microsoft Office Suite and regulatory software tools. 
• Ability to analyze and interpret complex regulatory information and provide clear guidance to the research team. 
• Self-motivated and proactive, with a commitment to continuous learning and professional development. 

PTO & Paid Holidays

4-day work week

Company paid health insurance with option to increase plan choices

Company paid vision insurance

Dental insurance

Company paid life insurance

Short- & Long-term disability 

Accidental/Hospital/Indemnity/Critical Illness insurance 

401k plan w/ match

Profit share, on eligible years

Company

sponsored appreciation events

Award/Recognition opportunities

Bonus 

Annual performance appraisals

Pay range $65,000.00