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Morehouse School of Medicine · 1 day ago

Clinical Trials Operations (CTO) Director – Clinical & Operational Implementation

Atlanta Metro

Full-time

Onsite

Director/Executive

7+ years exp

Morehouse School of Medicine is seeking a Clinical Trials Operations (CTO) Director to lead clinical trial implementation and performance. The CTO Director will oversee operational execution, ensure compliance with regulations, and manage financial aspects of clinical trials while collaborating with various departments.

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Responsibilities

Lead end-to-end operational execution of trials across departments/sites; integrate with clinical workflows to ensure participant safety and protocol fidelity

Build and enforce operational SOPs, playbooks, and feasibility/site-readiness tools aligned to policies approved by the CRC Associate Director and Quality/Compliance Core

Track activation/enrollment performance; remove barriers; escalate risks timely

Build/manage study budgets; forecast and monitor cost recovery and margin

Conduct/review Medicare Coverage Analyses ( MCA ) in collaboration with the CRC Associate Director and Compliance Office; implement operational billing controls to prevent double-billing and non-covered charges

Coordinate with OSP /Finance/Compliance on charge review workflows; deliver training on operational billing practices (policy ownership resides with Compliance/Associate Director)

Partner with the CRC Associate Director (regulatory/compliance owner) and Quality/Compliance Core to ensure operational adherence to ICH - GCP , FDA , OHRP , IRB , and institutional policy

Implement monitoring plans, risk assessments, and execute Operations-assigned CAPAs; maintain inspection-readiness checklists, eReg/ CTMS documentation quality, and version control under governance set by the Associate Director

Serve as the operational point of contact during audits/inspections (document assembly, interview prep, logistics); institutional regulatory leadership and responses are led by the CRC Associate Director

Co-develop operational KPIs (deviations, query cycle time, essential document timeliness) and review trends with Quality/Compliance; escalate significant issues to the Associate Director

Supervise research coordinators, research nurses, and billing/compliance analysts in operational domains; set competencies and performance goals

Provide rotations/exposure for trainees and staff; fellowship education is led by the CRC Associate Director—CTO supports by offering operational learning experiences and data

Drive adoption and disciplined use of CTMS , eReg, REDCap, and contract/analytics dashboards; co-administer systems per data governance established by the Associate Director/Quality

Publish operational dashboards (cycle times, accrual, monitoring actions, CAPA execution status) for leadership review

Activation cycle times; first-patient-in timelines

Operational audit readiness (document completeness, TMF /eReg timeliness) and on-time completion of Operations CAPAs

Billing error rate (post-adjudication) and MCA alignment in partnership with Compliance/Associate Director

Data quality (query aging, deviation rate) and enrollment diversity/retention

Staff competency completion, certification rates, and system utilization discipline

Qualification

Clinical licenseTrial start-up expertiseCTMS/eReg/REDCapACRP/SOCRA certificationFinancial managementLeadership experienceOperational SOPsAudit readinessData governanceCollaboration skills

Required

Master's degree in Health Care Administration, the pharmaceutical, biologic, or clinical research arena, with 7-10 years of progressive experience in clinical research operations, with strong collaboration experience in a clinical research environment

Degree must be from a regionally accredited college or university

Proven expertise in trial start-up, site execution, MCA, research billing workflows, and audit readiness from an operations standpoint

Facility with CTMS/eReg/REDCap; strong cross-functional leadership

Minimum of 8 years supervisory and/or leadership experience

Minimum of 5 years of financial responsibility for clinical trials