Clinical Research Site Manager ( {{city}})

About Denali Health Plant City

Denali Health Plant City is part of Denali Healths growing network of dedicated research sites advancing Phase IIV studies in vaccines, cardiometabolic disease, neurology, dermatology, wound care, and more. Our physicians and staff combine compassionate patient care with industry-leading enrollment performance and data quality, helping sponsors bring breakthrough therapies to market faster.

Position Overview

The Site Manager / Lead CRC is the operational heartbeat of our Plant City site. 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.

Key Responsibilities

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.

Financial Management

Oversee study billing grids, subject stipends, and vendor invoices.

Reconcile CTMS against payment schedules; flag discrepancies.

Participant Experience

Uphold a patient-centric culturesafe, respectful, and efficient visits.

Address participant questions, complaints, and retention initiatives.

Site Growth

Support business-development outreach and bid defenses for new trials.

Collaborate with marketing on community engagement and referrals.

Minimum Qualifications

• Bachelors degree in life sciences, nursing, public health, or related field (RN or foreign-trained MD a plus)
• 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

Preferred Qualifications

• ACRP-CP, CCRC, or SOCRA certification
• Vaccines or wound-care study experience
• Phlebotomy, ECG, and basic lab-processing skills
• Bilingual English/Spanish

What We Offer

• Competitive salary with annual performance bonus
• 401(k) plus company match
• Medical, dental, vision, and life insurance (effective Day 1)
• CME/professional development stipend
• 15 days PTO + 10 paid holidays
• Modern facility with cutting-edge research technology
• Fast-track career pathway into multi-site leadership as Denali expands

How to Apply

Send your rsum and a brief cover letter to [email protected] with the subject line Site Manager / Lead CRC Plant City. Applications are reviewed on a rolling basis; early submission is encouraged.

For questions, contact Maryam Hussaini, VP Clinical Operations, at (217) 933-2108.

Denali Health celebrates diversity and is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.