Clinical Research Site Manager at Denali Health Plant City, FL

Benefits

Qualifications

• •Uphold a patient-centric culture—safe, respectful, and efficient visits
• •4 + years of hands-on clinical-research coordination, including industry-sponsored trials
• •Proven experience supervising or mentoring CRCs or site support staff
• •Demonstrated success coordinating multi-disciplinary study teams and external vendors
• •In-depth knowledge of ICH-GCP, FDA regulations, and AE/SAE reporting
• •Strong command of CTMS, eReg, and EMR systems; able to troubleshoot and train others
• •Exceptional organizational skills with the agility to juggle multiple protocols
• •Excellent written and verbal communication; comfortable interacting with sponsors and PIs
• •5 more items(s)

Responsibilities

• •You will oversee day-to-day clinic activities, ensure protocol and GCP compliance, mentor study coordinators, coordinate cross-functional workflows , and serve as the primary liaison with sponsors, CRO monitors, and central Denali leadership
• •This role is perfect for a seasoned coordinator or site supervisor ready to take full ownership of site performance and growth
• •Study Start-Up & Feasibility
• •Evaluate protocols, budgets, and source documents for operational fit
• •Coordinate SIVs, investigator meetings, and regulatory submissions
• •Coordination
• •Facilitate day-to-day coordination among investigators, sub-investigators, CRCs, recruitment, lab, and pharmacy teams to keep all study milestones on track
• •Serve as the single point of contact (SPOC) for sponsors, CROs, central labs, imaging vendors, and other external partners, ensuring timely information flow and issue resolution
• •Coordinate patient scheduling to optimize visit flow and resource utilization across multiple concurrent protocols
• •Interface with Denali Health Atlanta and other network sites to share best practices, align SOPs, and support multi-center studies
• •Operational Leadership
• •Manage study-staff scheduling, training, and performance feedback
• •Track enrollment metrics and visit compliance; implement corrective actions to hit targets
• •Quality & Compliance
• •Maintain TMF/eTMF, regulatory binders, and ICF versions per 21 CFR 312 & ICH-GCP
• •Host monitoring visits, sponsor audits, and FDA/IRB inspections
• •Oversee study billing grids, subject stipends, and vendor invoices
• •Reconcile CTMS against payment schedules; flag discrepancies
• •Address participant questions, complaints, and retention initiatives
• •Support business-development outreach and bid defenses for new trials
• •Collaborate with marketing on community engagement and referrals
• •18 more items(s)