Morehouse School of Medicine
Clinical Trials Operations (CTO) Director – Clinical & Operational Implementatio
Morehouse School of Medicine, Atlanta, Georgia, United States, 30383
Clinical Trials Operations (CTO) Director – Clinical & Operational Implementation
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Clinical Trials Operations (CTO) Director – Clinical & Operational Implementation
role at
Morehouse School of Medicine
Position Summary
The CTO Director is the senior operational lead for clinical trial implementation and performance. The role partners closely with the CRC Associate Director (Physician, Regulatory/Compliance & Fellowship Education) and the Quality/Compliance Core to ensure operations adhere to institutional policies, ICH‑GCP, FDA/OHRP regulations, and payer rules. The CTO owns day‑to‑day operational execution (feasibility → start‑up → conduct → close‑out), implements the quality system, and executes CAPAs assigned to Operations—while policy, regulatory oversight, and final compliance authority remain with the CRC Associate Director.
Minimum Qualifications
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.
Clinical license (RN, NP, PA, or PharmD) preferred/active.
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.
ACRP / SOCRA certification preferred.
Minimum of 8 years supervisory and/or leadership experience.
Minimum of 5 years of financial responsibility for clinical trials.
Preferred Qualifications
MD, PharmD, and/or PhD in Life Sciences and/or MBA preferred. Degree must be from a regionally accredited college or university.
Society of Clinical Research Associates
Association of Clinical Research Professionals
Certified Clinical Research Professional or other related credentials
Description of Job Duty
Key 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; elevate 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 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; elevate 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.
Reporting Structure
Reports to: Director, Clinical Research Center (CRC).
Dotted‑line collaboration: CRC Associate Director (Physician; Regulatory/Compliance & Fellowship Education).
Supervises: Clinical Research Coordinators; Research Nurses; Financial/Billing Compliance Analysts (operations).
Key collaborators: Quality/Compliance Core, IRB, OSP, Finance/Revenue Cycle, Investigators, Academic departments and faculty, and Institutional Compliance/Privacy.
Seniority level
Director
Employment type
Full‑time
Job function
Information Technology
Industries: Higher Education
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Clinical Trials Operations (CTO) Director – Clinical & Operational Implementation
role at
Morehouse School of Medicine
Position Summary
The CTO Director is the senior operational lead for clinical trial implementation and performance. The role partners closely with the CRC Associate Director (Physician, Regulatory/Compliance & Fellowship Education) and the Quality/Compliance Core to ensure operations adhere to institutional policies, ICH‑GCP, FDA/OHRP regulations, and payer rules. The CTO owns day‑to‑day operational execution (feasibility → start‑up → conduct → close‑out), implements the quality system, and executes CAPAs assigned to Operations—while policy, regulatory oversight, and final compliance authority remain with the CRC Associate Director.
Minimum Qualifications
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.
Clinical license (RN, NP, PA, or PharmD) preferred/active.
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.
ACRP / SOCRA certification preferred.
Minimum of 8 years supervisory and/or leadership experience.
Minimum of 5 years of financial responsibility for clinical trials.
Preferred Qualifications
MD, PharmD, and/or PhD in Life Sciences and/or MBA preferred. Degree must be from a regionally accredited college or university.
Society of Clinical Research Associates
Association of Clinical Research Professionals
Certified Clinical Research Professional or other related credentials
Description of Job Duty
Key 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; elevate 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 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; elevate 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.
Reporting Structure
Reports to: Director, Clinical Research Center (CRC).
Dotted‑line collaboration: CRC Associate Director (Physician; Regulatory/Compliance & Fellowship Education).
Supervises: Clinical Research Coordinators; Research Nurses; Financial/Billing Compliance Analysts (operations).
Key collaborators: Quality/Compliance Core, IRB, OSP, Finance/Revenue Cycle, Investigators, Academic departments and faculty, and Institutional Compliance/Privacy.
Seniority level
Director
Employment type
Full‑time
Job function
Information Technology
Industries: Higher Education
#J-18808-Ljbffr