University of Maryland, Baltimore
Senior Director, Clinical Research Operations & Compliance
University of Maryland, Baltimore, Baltimore, Maryland, United States, 21276
The Kahlert Institute for Addiction Medicine with the University of Maryland School of Medicine’s Department of Psychiatry has an exciting opportunity for a
Senior Director, Clinical Research Operations & Compliance
.
Established through cooperative funding by the Kahlert Foundation, the University of Maryland, Baltimore (UMB), and the University of Maryland School of Medicine (UMSOM), the new Kahlert Institute for Addiction Medicine marks the start of a new era of pioneering research and clinical care in combatting substance use disorder (SUD). The Institute brings together leading addiction experts to collaborate and create the synergy necessary for systemic change in the management of this public health epidemic. UMSOM faculty play an integral part of the Institute, as: Neuroscientists studying the brain mechanisms underlying substance use and their impact across the lifespan. Clinical researchers exploring potential interventions in patient trials. Substance Use Disorder specialists who understand the daily realities of caring for patients with a complex disorder that often involves psychiatric illness, trauma, and socioeconomic stressors. UMSOM’s state-of-the-art Health Sciences Research Facility III (HSRF III) serves as the center for Kahlert Institute activities, creating a multidisciplinary hub where investigators share their expertise and innovative concepts together. HSRF III’s advanced labs are designed to fast-track both fundamental and translational science studies, while providing a fully integrated space for clinical care, clinical research, and educational instruction. The selected candidate will perform duties that support the institute.
Primary Duties Develops short- and long-term operational goals on submitted and anticipated projects. Responsible for achieving strategic objectives of the center. Provides clinical research center operations oversight and direction to clinical staff. Ensures faculty and staff needs are met. Consults with leadership in development of budgets for the clinical operations. Provides guidance and management to the unit with regard to clinical research, continuous improvement, clinical operations, and compliance issues. Develop standard operating guidelines, processes, and procedures for unit. Responsible for the clinical research compliance for the unit and resource allocation, that includes budget and human resources. Work with clinical researchers to determine project requirements and design; set priorities, facilitate communications, and develops and execute data collections systems that facilitate the applications, consultations, and distribution of resources. Direct the development and implementation of procedures, protocols, and process for clinical operations, incorporates novel techniques, new equipment and pipelines, and data analysis methods to maximize efficiency. Delivers strategic decisions based upon goals and objectives. Identify and develop clinical research opportunities to promote and expand units impact on the University's goals. Guides, challenges, and motivates large department to achieve long- and short term University and school/department goals and plans. Works with leadership on short- and long-term critical issues, projects, plans, and University strategic goals without supervision. Oversees all other administrative functions such as information technology and data development projects; capital equipment planning and management; general procurement; staffing, payroll, and accounting. Ensures all clinical research complies with local institutional review board (IRB) guidelines, research and development guidelines and all relevant federal, state, and local rules and regulations. Monitor and research developments in federal and state laws and regulations that have an impact on clinical research agreements and also impact affiliates and UMB legal and compliance programs. Work in collaboration with other affiliates or entities, such as UMMS, on clinical research matters that affect the UMB community. Proactively represents the school/department through participation in campus meetings and special projects, as well as UMB on an external basis with USM headquarters and other system-wide units. Management and oversight of staff, including hiring training, managing, performance assessment, and mentoring of supervisors, professionals, and support staff. Initiates, influences, and creates development opportunities to staff. Perform other duties as assigned.
Qualifications Education:
Bachelor's degree in discipline appropriate to position required. Master's degree preferred. Experience:
Nine (9) years of related experience in public health, clinical research, clinical trials, law, or related field with at least five (5) years of clinical research operations or compliance experience. May have expertise within specialty of the unit. Supervisory Experience:
Five (5) years of direct management of recruitment, training, and professional development of staff. Directly responsible for the performance of management and staff. Other:
Except for qualifications established by law, additional related experience and formal education in which one has gained the knowledge, skills, and abilities required for full performance of the work of the job class may be substituted for the education or experience requirement on a year-for-year basis with 30 undergraduate college credits being equivalent to one year of related experience.
Knowledge, Skills, and Abilities Thorough knowledge of position requirements. Thorough knowledge of all applicable requirements, regulations, and laws. Skill in effective use of applicable technology/systems. Ability to effectively communicate both verbal and written thoughts, ideas, and facts. Ability to support a mission and strategic vision. Instructional, training, and teambuilding skills to strengthen and cultivate relationships. Skill in consultation and change management. Ability to demonstrate, understand, apply, and adhere to the UMB Core Values of Respect and Integrity, Well-being and Sustainability, Equity and Justice, and Innovation and Discovery.
Hiring Range:
$157,000 - $177,000, commensurate with education and experience.
UMB is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law or policy.
If you anticipate needing a reasonable accommodation for a disability under the Americans with Disabilities Act (ADA), during any part of the employment process, please submit a UMB Job Applicant Accommodation Request.
The University of Maryland, Baltimore prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to the Title IX Coordinator.
#J-18808-Ljbffr
Senior Director, Clinical Research Operations & Compliance
.
Established through cooperative funding by the Kahlert Foundation, the University of Maryland, Baltimore (UMB), and the University of Maryland School of Medicine (UMSOM), the new Kahlert Institute for Addiction Medicine marks the start of a new era of pioneering research and clinical care in combatting substance use disorder (SUD). The Institute brings together leading addiction experts to collaborate and create the synergy necessary for systemic change in the management of this public health epidemic. UMSOM faculty play an integral part of the Institute, as: Neuroscientists studying the brain mechanisms underlying substance use and their impact across the lifespan. Clinical researchers exploring potential interventions in patient trials. Substance Use Disorder specialists who understand the daily realities of caring for patients with a complex disorder that often involves psychiatric illness, trauma, and socioeconomic stressors. UMSOM’s state-of-the-art Health Sciences Research Facility III (HSRF III) serves as the center for Kahlert Institute activities, creating a multidisciplinary hub where investigators share their expertise and innovative concepts together. HSRF III’s advanced labs are designed to fast-track both fundamental and translational science studies, while providing a fully integrated space for clinical care, clinical research, and educational instruction. The selected candidate will perform duties that support the institute.
Primary Duties Develops short- and long-term operational goals on submitted and anticipated projects. Responsible for achieving strategic objectives of the center. Provides clinical research center operations oversight and direction to clinical staff. Ensures faculty and staff needs are met. Consults with leadership in development of budgets for the clinical operations. Provides guidance and management to the unit with regard to clinical research, continuous improvement, clinical operations, and compliance issues. Develop standard operating guidelines, processes, and procedures for unit. Responsible for the clinical research compliance for the unit and resource allocation, that includes budget and human resources. Work with clinical researchers to determine project requirements and design; set priorities, facilitate communications, and develops and execute data collections systems that facilitate the applications, consultations, and distribution of resources. Direct the development and implementation of procedures, protocols, and process for clinical operations, incorporates novel techniques, new equipment and pipelines, and data analysis methods to maximize efficiency. Delivers strategic decisions based upon goals and objectives. Identify and develop clinical research opportunities to promote and expand units impact on the University's goals. Guides, challenges, and motivates large department to achieve long- and short term University and school/department goals and plans. Works with leadership on short- and long-term critical issues, projects, plans, and University strategic goals without supervision. Oversees all other administrative functions such as information technology and data development projects; capital equipment planning and management; general procurement; staffing, payroll, and accounting. Ensures all clinical research complies with local institutional review board (IRB) guidelines, research and development guidelines and all relevant federal, state, and local rules and regulations. Monitor and research developments in federal and state laws and regulations that have an impact on clinical research agreements and also impact affiliates and UMB legal and compliance programs. Work in collaboration with other affiliates or entities, such as UMMS, on clinical research matters that affect the UMB community. Proactively represents the school/department through participation in campus meetings and special projects, as well as UMB on an external basis with USM headquarters and other system-wide units. Management and oversight of staff, including hiring training, managing, performance assessment, and mentoring of supervisors, professionals, and support staff. Initiates, influences, and creates development opportunities to staff. Perform other duties as assigned.
Qualifications Education:
Bachelor's degree in discipline appropriate to position required. Master's degree preferred. Experience:
Nine (9) years of related experience in public health, clinical research, clinical trials, law, or related field with at least five (5) years of clinical research operations or compliance experience. May have expertise within specialty of the unit. Supervisory Experience:
Five (5) years of direct management of recruitment, training, and professional development of staff. Directly responsible for the performance of management and staff. Other:
Except for qualifications established by law, additional related experience and formal education in which one has gained the knowledge, skills, and abilities required for full performance of the work of the job class may be substituted for the education or experience requirement on a year-for-year basis with 30 undergraduate college credits being equivalent to one year of related experience.
Knowledge, Skills, and Abilities Thorough knowledge of position requirements. Thorough knowledge of all applicable requirements, regulations, and laws. Skill in effective use of applicable technology/systems. Ability to effectively communicate both verbal and written thoughts, ideas, and facts. Ability to support a mission and strategic vision. Instructional, training, and teambuilding skills to strengthen and cultivate relationships. Skill in consultation and change management. Ability to demonstrate, understand, apply, and adhere to the UMB Core Values of Respect and Integrity, Well-being and Sustainability, Equity and Justice, and Innovation and Discovery.
Hiring Range:
$157,000 - $177,000, commensurate with education and experience.
UMB is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law or policy.
If you anticipate needing a reasonable accommodation for a disability under the Americans with Disabilities Act (ADA), during any part of the employment process, please submit a UMB Job Applicant Accommodation Request.
The University of Maryland, Baltimore prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to the Title IX Coordinator.
#J-18808-Ljbffr