Morehouse School of Medicine
Director of Clinical Research Programs Operations
Morehouse School of Medicine, Baltimore, Maryland, United States,
Director of Clinical Research Programs Operations
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 underserved 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:
NONAC3370 Job Title:
Director of Clinical Research Programs Operations Position Type:
Non-Faculty Number of Vacancies:
1 Salary:
Commensurate with experience Position Summary: The Cardiovascular Research Institute (CVRI) at the Morehouse School of Medicine aims to be the leading transformational force for health equity in Digital Epidemiology and research. Over the past decade, the CVRI has successfully recruited a talented critical mass of faculty with a wide breadth of scientific expertise that has enriched the intellectual capital of the institution and created one of the largest research portfolios at MSM. Our ongoing process of strategic planning and evaluation has enabled CVRI to build upon its success and emerge as an internationally recognized Center of Excellence in cardiovascular science. The CVRI is seeking a Director of Clinical Research Programs Operations who is passionate about clinical research and project management. The DCRPO will report to the Associate Director, Clinical Research, of the CVRI and work with a robust clinical research team, hand in hand with Principal Investigators, Clinical Research Managers, Program Managers, and Associates in support of cardiovascular disease research trials participants. The DCRPO will manage clinical research operations, relationships with other affinity groups and staff, study quality management, personnel management and career skill development, regulatory compliance, and fiscal oversight. The DCRPO will also assist with building automated clinical research workflows and solutions within the CVRI. The successful applicant will have the ability to supervise multiple clinical research staff, collaborate with external vendors, and enjoy working in a dynamic work environment. Exceptional diplomacy, interpersonal, and communication skills are essential, as is a high degree of integrity. Attention to detail and the ability to manage multiple responsibilities simultaneously are also critical attributes. Key Functions: Financial Management (operations, contract procurement, budget setup, purchasing, performance against budget, grant/contract compliance) Grant Management (coordination with MSM Grants and Contracts and OSRA, as well as small grant recipients from MSIs and the technical Cores within the Clinician’s Fellowship Program) Report preparation and dissemination (monitoring of activities and units, strong recordkeeping, some budget and financial reconciliation) Duties: Leads the AIM-AHEAD Clinician’s Fellowship Program. Conceives and implements strategies to achieve AIM-AHEAD Clinician’s Fellowship Program milestones and deliverables. Establishes priorities for Fellowship Program management and budget activities. Develop proposals and identify strategies and approaches to maximize the impact of AIM-AHEAD, especially implementing processes that will streamline transdisciplinary collaboration. Designs and oversees the implementation of AIM-AHEAD marketing, communication, and outreach activities within the Clinician’s Fellowship Program. Prepares and submits AIM-AHEAD Clinician’s Fellowship Program monthly reports to Administrative Leadership Core and NIH, inclusive of budget, strategic direction, schedule, and performance measures. Supervises AIM-AHEAD technical and administrative support staff, as well as sub-contractors. Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials. Monitor staffing levels and identify adequate coverage for trial workload across teams of study coordinators. Supervise the implementation of and adherence to study protocols. Educate research staff on established policies, processes, and procedures. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Develop consent forms for approval by Human Subjects Panel. Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA, and other regulatory agencies. Submit Investigational New Drug applications to the FDA as required. Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions and respond to requests and questions. Provide leadership and expertise in identifying and completing research grants. Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group. Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences. Analyze trends in recruitment and assure there is a limited number of competing trials. Make recommendations for a variety of options within a trial; track physician compliance. Assist with analysis of data and preparation of manuscripts and scientific presentations. Minimum Qualifications: Work requires organizational, analytical, and communication skills normally acquired through the completion of a master’s degree in project management, business administration, healthcare administration, or a related field. Minimum of 5-8 years of administrative experience with operations, finance, and personnel management, preferably in an academic or healthcare administration setting. Proven ability to adeptly manage multiple priorities and tasks. Intermediate to advanced computer skills and proficiency in MS Word, Excel, PowerPoint, and Outlook are required, as well as familiarity with virtual tools to facilitate group communication and information exchange (e.g., ZOOM, Slack, MS Teams). Strong interpersonal skills with the ability to interface effectively both internally and externally with a wide range of people including academic faculty, physicians, administrators, government agencies, AI/ML/IT/Data Science professionals, NGOs, and community members. Minimum of five years of experience managing budgets in excess of $500,000. Preferred Qualifications: Experience in higher education, undergraduate medical education or graduate medical education, or hospital administration is preferred. Minimum of five years of experience managing sponsored research funds (NIH, NSF, DoD). Action-oriented, program development skills, and skill in leveraging resources effectively and efficiently. Ability to collaborate with others across multiple levels of an organization to achieve results and build relationships of trust among various internal and external stakeholders. Proven record of accomplishment in exercising discretion and independent judgment effectively in decision-making processes. Experience leading or moderating collaborations, ranging from multidisciplinary team science, AI/ML professionals, financial administrators, and clinicians. Experience adapting to changing environments and navigating organizational dynamics. Ability to develop and execute several key projects while simultaneously and continually setting priorities on emerging requirements and changing timelines effectively and efficiently. 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. 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 required 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. Required Documents: Cover Letter Curriculum Vitae or Resume Optional Documents: Writing Sample Professional License Other Document Our vision is to lead the creation and advancement of health equity. Morehouse School of Medicine 720 Westview Drive Atlanta, GA 30310 404-752-1500 Partner Site(s): Morehouse Healthcare
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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 underserved 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:
NONAC3370 Job Title:
Director of Clinical Research Programs Operations Position Type:
Non-Faculty Number of Vacancies:
1 Salary:
Commensurate with experience Position Summary: The Cardiovascular Research Institute (CVRI) at the Morehouse School of Medicine aims to be the leading transformational force for health equity in Digital Epidemiology and research. Over the past decade, the CVRI has successfully recruited a talented critical mass of faculty with a wide breadth of scientific expertise that has enriched the intellectual capital of the institution and created one of the largest research portfolios at MSM. Our ongoing process of strategic planning and evaluation has enabled CVRI to build upon its success and emerge as an internationally recognized Center of Excellence in cardiovascular science. The CVRI is seeking a Director of Clinical Research Programs Operations who is passionate about clinical research and project management. The DCRPO will report to the Associate Director, Clinical Research, of the CVRI and work with a robust clinical research team, hand in hand with Principal Investigators, Clinical Research Managers, Program Managers, and Associates in support of cardiovascular disease research trials participants. The DCRPO will manage clinical research operations, relationships with other affinity groups and staff, study quality management, personnel management and career skill development, regulatory compliance, and fiscal oversight. The DCRPO will also assist with building automated clinical research workflows and solutions within the CVRI. The successful applicant will have the ability to supervise multiple clinical research staff, collaborate with external vendors, and enjoy working in a dynamic work environment. Exceptional diplomacy, interpersonal, and communication skills are essential, as is a high degree of integrity. Attention to detail and the ability to manage multiple responsibilities simultaneously are also critical attributes. Key Functions: Financial Management (operations, contract procurement, budget setup, purchasing, performance against budget, grant/contract compliance) Grant Management (coordination with MSM Grants and Contracts and OSRA, as well as small grant recipients from MSIs and the technical Cores within the Clinician’s Fellowship Program) Report preparation and dissemination (monitoring of activities and units, strong recordkeeping, some budget and financial reconciliation) Duties: Leads the AIM-AHEAD Clinician’s Fellowship Program. Conceives and implements strategies to achieve AIM-AHEAD Clinician’s Fellowship Program milestones and deliverables. Establishes priorities for Fellowship Program management and budget activities. Develop proposals and identify strategies and approaches to maximize the impact of AIM-AHEAD, especially implementing processes that will streamline transdisciplinary collaboration. Designs and oversees the implementation of AIM-AHEAD marketing, communication, and outreach activities within the Clinician’s Fellowship Program. Prepares and submits AIM-AHEAD Clinician’s Fellowship Program monthly reports to Administrative Leadership Core and NIH, inclusive of budget, strategic direction, schedule, and performance measures. Supervises AIM-AHEAD technical and administrative support staff, as well as sub-contractors. Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials. Monitor staffing levels and identify adequate coverage for trial workload across teams of study coordinators. Supervise the implementation of and adherence to study protocols. Educate research staff on established policies, processes, and procedures. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Develop consent forms for approval by Human Subjects Panel. Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA, and other regulatory agencies. Submit Investigational New Drug applications to the FDA as required. Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions and respond to requests and questions. Provide leadership and expertise in identifying and completing research grants. Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group. Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences. Analyze trends in recruitment and assure there is a limited number of competing trials. Make recommendations for a variety of options within a trial; track physician compliance. Assist with analysis of data and preparation of manuscripts and scientific presentations. Minimum Qualifications: Work requires organizational, analytical, and communication skills normally acquired through the completion of a master’s degree in project management, business administration, healthcare administration, or a related field. Minimum of 5-8 years of administrative experience with operations, finance, and personnel management, preferably in an academic or healthcare administration setting. Proven ability to adeptly manage multiple priorities and tasks. Intermediate to advanced computer skills and proficiency in MS Word, Excel, PowerPoint, and Outlook are required, as well as familiarity with virtual tools to facilitate group communication and information exchange (e.g., ZOOM, Slack, MS Teams). Strong interpersonal skills with the ability to interface effectively both internally and externally with a wide range of people including academic faculty, physicians, administrators, government agencies, AI/ML/IT/Data Science professionals, NGOs, and community members. Minimum of five years of experience managing budgets in excess of $500,000. Preferred Qualifications: Experience in higher education, undergraduate medical education or graduate medical education, or hospital administration is preferred. Minimum of five years of experience managing sponsored research funds (NIH, NSF, DoD). Action-oriented, program development skills, and skill in leveraging resources effectively and efficiently. Ability to collaborate with others across multiple levels of an organization to achieve results and build relationships of trust among various internal and external stakeholders. Proven record of accomplishment in exercising discretion and independent judgment effectively in decision-making processes. Experience leading or moderating collaborations, ranging from multidisciplinary team science, AI/ML professionals, financial administrators, and clinicians. Experience adapting to changing environments and navigating organizational dynamics. Ability to develop and execute several key projects while simultaneously and continually setting priorities on emerging requirements and changing timelines effectively and efficiently. 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. 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 required 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. Required Documents: Cover Letter Curriculum Vitae or Resume Optional Documents: Writing Sample Professional License Other Document Our vision is to lead the creation and advancement of health equity. Morehouse School of Medicine 720 Westview Drive Atlanta, GA 30310 404-752-1500 Partner Site(s): Morehouse Healthcare
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