Atlanta Staffing
Clinical Trials Operations (CTO) Director Clinical & Operational Implementation
Atlanta Staffing, Atlanta, Georgia, United States, 30301
Clinical Trials Operations (CTO) Director
Clinical & Operational Implementation
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 Operationswhile 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. Preferred Certifications: Society of Clinical Research Associates Association of Clinical Research Professionals Certified Clinical Research Professional or other related credentials Job Duties: 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 DirectorCTO 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 Pre-Employment/Employment Requirements: All offers of employment are contingent upon successful completion of all pre-employment screenings. 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. 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
Clinical & Operational Implementation
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 Operationswhile 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. Preferred Certifications: Society of Clinical Research Associates Association of Clinical Research Professionals Certified Clinical Research Professional or other related credentials Job Duties: 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 DirectorCTO 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 Pre-Employment/Employment Requirements: All offers of employment are contingent upon successful completion of all pre-employment screenings. 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. 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