About Sarasota Arthritis Center

Sarasota Arthritis Center is a leading rheumatology practice with offices in Sarasota, Bradenton, and Venice, Florida. For over 40 years, we’ve provided compassionate, state-of-the-art care for patients with autoimmune and rheumatic diseases. Our board-certified physicians and experienced clinical team offer comprehensive services including on-site infusion therapy, laboratory testing, and clinical research. We take pride in combining medical excellence with a supportive, collaborative work environment where both patients and staff thrive.

Overview

The Lead Clinical Research Coordinator (CRC) oversees the daily operations of the Research Department within the rheumatology practice. This role ensures the successful planning, implementation, and management of all clinical trials in accordance with study protocols, regulatory requirements, ICH/GCP and site standard operating procedures (SOPs). The Lead CRC provides direct supervision and guidance to research staff, manages study timelines, and serves as the primary liaison between investigators, sponsors, CROs, and the clinical team.

 
Key Responsibilities
Study Management

·         Coordinate and oversee all aspects of clinical research trials from initiation through close-out.

·         Review and interpret study protocols to ensure compliance with sponsor, IRB, FDA, and ICH GCP requirements.

·         Ensure accurate source documentation, informed consent processes, and data integrity across all studies.

·         Maintain investigator site files, regulatory binders, and study correspondence.

·         Monitor subject recruitment progress and implement strategies to meet enrollment goals.

·         Conduct study visits per protocol, including vital signs, lab collection, EKGs, and other study-specific assessments.

·         Ensure all study related equipment is properly maintained

·         Ensure all investigational product is properly maintained, according to Good Clinical Practice, regulations and protocol requirements

Supervisory Oversight

·         Supervise and train Clinical Research Coordinators and Research Assistants.

·         Contribute feedback to performance reviews.

·         Assign daily responsibilities, monitor workload distribution, and ensure quality performance.

·         Collaborate with the Principal Investigator (PI) to ensure adherence to study protocols and regulatory obligations.

·         Conduct regular team meetings to review progress, address challenges, and maintain protocol compliance.

Regulatory Compliance

·         Assist with preparing, submitting, and maintaining regulatory documents for IRB submissions, amendments, and continuing reviews.

·         Ensure all staff are trained and compliant with ICH/GCP and study-specific requirements.

·         Coordinate and participate in sponsor and regulatory audits or monitoring visits.

·         Ensure all studies and the department are in a state of inspection readiness at all times.

·         Manage site audits and inspections as applicable.

Collaboration & Communication

·         Serve as the primary point of contact for sponsors, CROs, and vendors.

·         Work closely with physicians, clinical staff, and administration to integrate research operations into daily clinic flow.

·         Maintain effective communication with study participants regarding schedules, instructions, and follow-up visits.

Operations

·         Develop and maintain SOPs for the Research Department.

·         Negotiate and track study budgets, and payments. Ensuring accurate billing and invoicing of research activities.

·         Participate in feasibility assessments for new studies and contribute to business development initiatives.

Other Duties as Assigned

·         This job description is not designed to cover or contain a comprehensive list of activities, duties, or responsibilities that are required of the employee. They may change, or new ones may be assigned at any time with or without notice. 

Qualifications

·         Bachelor’s degree in health sciences, nursing, or related field required.

·         Minimum 3–5 years of clinical research experience, with at least 1 year in a lead or supervisory role.

·         Certification as a Clinical Research Coordinator (CCRC) through ACRP or SoCRA strongly preferred.

·         Strong knowledge of GCP, FDA, and ICH guidelines.

·         Experience with rheumatology or autoimmune disease studies preferred.

·         Exceptional organizational skills, attention to detail, and ability to manage multiple studies concurrently.

·         Excellent communication and leadership skills.