Henry Ford Health
Medical Director, Central Clinical Trials Office
Henry Ford Health, Detroit, Michigan, United States, 48228
The Medical Director, Central Clinical Trials Office (MDCTO) in the Office of Research Administration (ORA) at Henry Ford Health System (HFHS) will be responsible for overseeing and enhancing the performance of clinical trials across HFHS, in close partnership with the VP, Research (VPR) and clinical research leaders across the system, while ensuring compliance with federal and state regulatory requirements. The Position will report to the VPR/Chief Scientific Officer of HFHS.
The MDCTO will work closely with the Director of the Central Clinical Trials Office to oversee Clinical Trial policy development and compliance, ensuring that all research is conducted according to federal and other regulatory standards (e.g. FDA Good Clinical Practice (GCP), International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Office for Human Research Protections (OHRP), Joint Commission, Centers for Medicaid and Medicare Services (CMS), Association for the Accreditation of Human Research Protection Programs (AAHRP), etc.).
Success will require close collaboration with the clinical departments, research administration divisions (e.g. IRB, contracting and Biorepository), and other units that support the development and execution of clinical research studies.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Collaborate with the VPR/CSO to establish the vision, strategic goals and priorities for the CTO.
Partner with clinical department chairs, division chiefs, and center/institute directors to pursue a growing, diverse portfolio of high-impact trials.
Oversee a high-performance, customer-oriented centralized infrastructure that supports investigators to design and execute clinical research studies.
Develop and maintain performance expectations and metrics and drive continuous improvement in processes and infrastructure that underpin clinical research at HFHS.
EDUCATION/EXPERIENCE/SKILLS REQUIRED:
MD/DO degree.
History of successful clinical trial activity from diverse funding sources, including both Federal and private sector.
Deep knowledge of protocol/study development as well as all regulatory guidelines applicable to clinical trials.
Experience in the IRB process strongly preferred.
At least 10 years’ experience in clinical trials with direct oversight of clinical trial operations.
Strong track record of achievement as an investigator in clinical trials and translational research.
Skill in building and maintaining collaborative relationships with physician investigators as well as clinical research support personnel.
Excellent leadership skills and ability to drive results.
CERTIFICATIONS/LICENSURES REQUIRED:
Must meet or exceed core customer service responsibilities, standards and behaviors as outlined in the HFHS’ Customer Service Policy and summarized below:
Communication
Ownership
Understanding
Motivation
Sensitivity
Excellence
Teamwork
Respect
Must practice the customer skills as provided through ongoing training and in-services.
Must possess the following personal qualities:
Be self-directed.
Be flexible and committed to the team concept.
Demonstrate teamwork, initiative, and willingness to learn.
Be open to new learning experiences.
Accept and respect diversity without judgment.
Demonstrate customer service values.
PHYSICAL DEMANDS/WORKING CONDITIONS:
Normal office environment with minimal exposure to noise, dust, or extreme temperatures.
Additional Details
This posting represents the major duties, responsibilities, and authorities of this job, and is not intended to be a complete list of all tasks and functions. It should be understood, therefore, that incumbents may be asked to perform job-related duties beyond those explicitly described above.
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The MDCTO will work closely with the Director of the Central Clinical Trials Office to oversee Clinical Trial policy development and compliance, ensuring that all research is conducted according to federal and other regulatory standards (e.g. FDA Good Clinical Practice (GCP), International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Office for Human Research Protections (OHRP), Joint Commission, Centers for Medicaid and Medicare Services (CMS), Association for the Accreditation of Human Research Protection Programs (AAHRP), etc.).
Success will require close collaboration with the clinical departments, research administration divisions (e.g. IRB, contracting and Biorepository), and other units that support the development and execution of clinical research studies.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Collaborate with the VPR/CSO to establish the vision, strategic goals and priorities for the CTO.
Partner with clinical department chairs, division chiefs, and center/institute directors to pursue a growing, diverse portfolio of high-impact trials.
Oversee a high-performance, customer-oriented centralized infrastructure that supports investigators to design and execute clinical research studies.
Develop and maintain performance expectations and metrics and drive continuous improvement in processes and infrastructure that underpin clinical research at HFHS.
EDUCATION/EXPERIENCE/SKILLS REQUIRED:
MD/DO degree.
History of successful clinical trial activity from diverse funding sources, including both Federal and private sector.
Deep knowledge of protocol/study development as well as all regulatory guidelines applicable to clinical trials.
Experience in the IRB process strongly preferred.
At least 10 years’ experience in clinical trials with direct oversight of clinical trial operations.
Strong track record of achievement as an investigator in clinical trials and translational research.
Skill in building and maintaining collaborative relationships with physician investigators as well as clinical research support personnel.
Excellent leadership skills and ability to drive results.
CERTIFICATIONS/LICENSURES REQUIRED:
Must meet or exceed core customer service responsibilities, standards and behaviors as outlined in the HFHS’ Customer Service Policy and summarized below:
Communication
Ownership
Understanding
Motivation
Sensitivity
Excellence
Teamwork
Respect
Must practice the customer skills as provided through ongoing training and in-services.
Must possess the following personal qualities:
Be self-directed.
Be flexible and committed to the team concept.
Demonstrate teamwork, initiative, and willingness to learn.
Be open to new learning experiences.
Accept and respect diversity without judgment.
Demonstrate customer service values.
PHYSICAL DEMANDS/WORKING CONDITIONS:
Normal office environment with minimal exposure to noise, dust, or extreme temperatures.
Additional Details
This posting represents the major duties, responsibilities, and authorities of this job, and is not intended to be a complete list of all tasks and functions. It should be understood, therefore, that incumbents may be asked to perform job-related duties beyond those explicitly described above.
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