Morehouse School of Medicine

About MSM

Morehouse School of Medicine (MSM) is a place of distinction, serving as the nation’s leading academic medical center for vulnerable populations. It’s also a place for passionate individuals looking to join a dedicated community working today to help prepare tomorrow’s leaders.

We exist to:

• Improve the health and well-being of individuals and communities;
• Increase the diversity of the health professional and scientific workforce;
• Address primary health care through programs in education, research and service;

With emphasis on people of color and the under-served urban and rural populations in Georgia, the nation and the world.

At Morehouse School of Medicine, we’re leading the creation and advancement of health equity. You will find a fulfilling career at MSM!

Posting Number NONAC3673

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

Position Title Director of Clinical Trials Office

Position Type Non-Faculty

Number of vacancies 1

Salary Commensurate with experience

Department Sponsored Rsch Admin

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.

Qualifications

• 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.

Preferred Certifications Preferred

• Society of Clinical Research Associates
• Association of Clinical Research Professionals
• Certified Clinical Research Professional or other related credentials

Closing Date

Open Until Filled Yes

Special Instructions to Applicants

Employment in this role may be contingent upon extramural funding and successful performance and may be terminated or reduced in percentage of appointment if such funding is not secured or ceases to be available.

Quick Link https://careers.msm.edu/postings/23623

EEO Statement Summary

Morehouse School of Medicine is an equal opportunity/equal access/affirmative action employer fully committed to achieving a diverse workforce and complies with all Federal and Georgia State laws, regulations, and executive orders regarding non-discrimination and affirmative action. Morehouse School of Medicine does not discriminate on the basis of race, age, color, religion, national origin or ancestry, sex, gender, disability, veteran status, genetic information, sexual orientation, or gender identity or expression.

Description of Job Duty

Key Responsibilities

Clinical & Operational Leadership

• 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.

Financial Management & Billing Compliance (Operational Execution)

• 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).

Regulatory & Quality Collaboration (Not Ownership)

• 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.

Workforce Development & Team Supervision

• 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.

Digital Operations & Analytics

• 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.

Performance Metrics (Operations-Focused, Jointly Reviewed)

• 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.

SUPERVISORY RESPONSIBILITIES:

Clinical Trials staff

Immunization Requirements

It is MSM’s Immunization policy that all Prospective Employees are encouraged to provide proof that they are vaccinated against COVID-19 prior to commencement of employment. If employment will commence during Flu Season, MSM requires all individuals to provide proof that they are vaccinated against Seasonal Influenza for the current Flu Season, unless granted an exemption. Failure to provide proof of vaccination for any required vaccines or obtain an exemption from MSM will result in rescission of a candidate’s offer of employment or disciplinary action up to and including termination.

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