Clinical Trials Operations (CTO) Director u2013 ...

Clinical Trials Operations (CTO) Director u2013 Clinical & Operational Implementation Bookmark this Posting Print Preview Apply for this Job Please see Special Instructions for more details. 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. Posting Details Position Information About MSM Morehouse School of Medicine ( MSM ) is a place of distinction, serving as the nationu2019s leading academic medical center for vulnerable populations. Itu2019s also a place for passionate individuals looking to join a dedicated community working today to help prepare tomorrowu2019s leaders. We exist to: u2022 Improve the health and well-being of individuals and communities; u2022 Increase the diversity of the health professional and scientific workforce; u2022 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, weu2019re 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 u2013 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 u2192 start-up u2192 conduct u2192 close-out), implements the quality system, and executes CAPAs assigned to Operationsu2014while policy, regulatory oversight, and final compliance authority remain with the CRC Associate Director. Minimum Qualifications Masteru2019s 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 u2022 Clinical license (RN, NP, PA, or PharmD) preferred/active. u2022 Proven expertise in trial start-up, site execution, MCA , research billing workflows, and audit readiness from an operations standpoint. u2022 Facility with CTMS /eReg/REDCap; strong cross-functional leadership. u2022 ACRP / SOCRA certification preferred. u2022 Minimum of 8 years supervisory and/or leadership experience. u2022 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 u2022 Society of Clinical Research Associates u2022 Association of Clinical Research Professionals u2022 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 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. Job Duties Description of Job Duty Key Responsibilities Clinical & Operational Leadership u2022 Lead end-to-end operational execution of trials across departments/sites; integrate with clinical workflows to ensure participant safety and protocol fidelity. u2022 Build and enforce operational SOPs, playbooks, and feasibility/site-readiness tools aligned to policies approved by the CRC Associate Director and Quality/Compliance Core. u2022 Track activation/enrollment performance; remove barriers; escalate risks timely. Financial Management & Billing Compliance (Operational Execution) u2022 Build/manage study budgets; forecast and monitor cost recovery and margin. u2022 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. u2022 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) u2022 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. u2022 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. u2022 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. u2022 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 u2022 Supervise research coordinators, research nurses, and billing/compliance analysts in operational domains; set competencies and performance goals. u2022 Provide rotations/exposure for trainees and staff; fellowship education is led by the CRC Associate Directoru2014CTO supports by offering operational learning experiences and data. Digital Operations & Analytics u2022 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. u2022 Publish operational dashboards (cycle times, accrual, monitoring actions, CAPA execution status) for leadership review. Performance Metrics (Operations-Focused, Jointly Reviewed) u2022 Activation cycle times; first-patient-in timelines. u2022 Operational audit readiness (document completeness, TMF /eReg timeliness) and on-time completion of Operations CAPAs. u2022 Billing error rate (post-adjudication) and MCA alignment in partnership with Compliance/Associate Director. u2022 Data quality (query aging, deviation rate) and enrollment diversity/retention. u2022 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 Pre-Employment/Employment Requirements All offers of employment are contingent upon successful completion of all pre-employment screenings. Immunization Immunization Requirements It is MSMu2019s 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 candidateu2019s offer of employment or disciplinary action up to and including termination. Posting Specific Questions Required fields are indicated with an asterisk (). + What is your highest level of completed education? + High School/GED + Associate's Degree + Bachelor's Degree + Master's Degree + EdD, MD, PhD, DrPH, JD + Please list any certifications that you have in Clinical Research (i.e.: Society of Clinical Research Associates, Association of Clinical Research Professionals, Certified Clinical Research Professional or other related credentials). (Open Ended Question) + Please describe how this position fits in with your professional goals and objectives. (Open Ended Question) + What licensure do you currently hold, and what is the status? Please use the upload function to upload a copy of your active license if applicable. + I have an active RN license_ + I am a RN without an active license + I have an active NP license + I am an NP without an active license + I am a PA with an active license + I am a PA without an active license + I am a PharmD with an active license + I am a PharmD without an active license + How many years of leadership experience, managing a team and department, do you have? Please list the size of the team and detail your responsibilities leading the department. (Open Ended Question) + Please provide your salary requirement. Do Not Enter Negotiable, a specified salary range is required. Not providing a salary requirement will result in your application being incomplete and will not be considered. (Open Ended Question) Applicant Documents Required Documents + Cover Letter + Curriculum Vitae or Resume Optional Documents + Professional License + Other Document

Created: 2025-12-22