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Job Description
About Denali Health Plant City
Denali Health Plant City is part of Denali Health’s growing network of dedicated research sites advancing Phase I–IV 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 culture—safe, 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
Bachelor’s 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
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 résumé and a brief cover letter to
hr@denali-health.com
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 and is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to , , , , , , , , or veteran status.
About Denali Health Plant City
Denali Health Plant City is part of Denali Health’s growing network of dedicated research sites advancing Phase I–IV 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 culture—safe, 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
Bachelor’s 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
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 résumé and a brief cover letter to
hr@denali-health.com
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 and is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to , , , , , , , , or veteran status.