Baltimore, MD, 21217, USA
6 days ago
Director, Clinical Research Operations & Compliance
*University of Maryland, Baltimore (UMB) is currently seeking a Director of Clinical Research Operations & Compliance to join the Department of Radiation Oncology.*The position will lead clinical researchers. The position will perform significant managerial functions within area of responsibility. Possess subject matter expertise in a professional discipline. Achieve objectives through coordinated efforts of others, typically by managing recruitment, engagement, performance, and development of employees. Develop, implement, and manage goals and objectives. Participate in strategic planning. Determine and enforce processes, practices, and/or policies. Manage operations, workflow, projects, and/or systems that have strategic impact. Accountable for operational and/or financial resources. Accountable for legal and policy compliance. The Department of Radiation Oncology at the University of Maryland is a national leader in translational research in radiation therapy. It consistently ranks among the top 10 radiation oncology departments in the country for federal funding received for cutting-edge research. As of 2024, the department also ranks in the top 10 nationally and internationally for National Cancer Institute (NCI)-sponsored national clinical trials cooperative group accruals. The department’s research encompasses a wide range of areas, including: • Radiation as a Systemic Treatment Agent • Stereotactic Radiotherapy/Radiosurgery for Tumors in the Brain and Body • Real-Time Tumor Tracking, Brachytherapy, & Hyperthermia for Prostate Cancer • 3-D Treatment Planning • Intensity Modulated Radiotherapy (IMRT) • 4-Dimensional CT Simulation • Methods to Assess/Immobilize Tumor Motion • Methods to Assess Tumor Response to Radiotherapy Using Functional Imaging The department’s focus on promoting translational research includes integration of its radiobiology, physics, and clinical divisions, as well as collaboration with other basic science departments. This collaborative approach has led to significant advancements in radiation treatment technologies and techniques, making them available to patients across a six-site statewide network. The department is also recognized for its strong commitment to clinical trials. In 2023, the University of Maryland Greenebaum Comprehensive Cancer Center (UMGCCC) ranked third in the United States as a top accruing main member for NRG Oncology trials. This strong reputation in research has led UMGCCC to be one of only four cancer centers in the country to have a Master Research Agreement with Varian Medical Systems, the market leader in the development of medical technology. The department’s research mission is to facilitate and provide services to: • UM Faculty Researchers: Assisting with study start-up and administration. • Patients and the General Public: Providing up-to-date information about ongoing clinical studies in the University of Maryland Department of Radiation Oncology. • Sponsors: Helping to identify University of Maryland investigators for research participation. *BENEFITS (Exempt Regular):* UMB offers a comprehensive benefits package that prioritizes wellness, work/life balance, and professional development, along with additional exciting perksthat employees can take advantage of. This position participates in a retirement program (pension or optional retirement plan/ORP) that must be selected and is effective on your date of hire. Exempt regular staff receive a generous PAID leave package that includes over 4 weeks of vacation accrued each year, 16 paid holidays, 3 personal leave, unlimited accrual of sick time, and comprehensive health insurance; professional learning and development programs; tuition remission for employees and their dependents at any University System of Maryland school; and flexible work schedules and teleworking options (if applicable per job).*/ /* *UMB is a public university and constituent institution of the University System of Maryland. All employees are expected to work primarily physically within the State of Maryland.* ** *PRIMARY DUTIES* * Direct strategic initiatives for the research operations of the large clinical research center and is responsible for short- and long-term University goals and department direction that have internal and external impact. Identify strategic decisions to be made based upon goals and objectives * Responsible for operations and compliance activities that support short- and long-term University and school/department plans. * Guide, challenge, and motivate department to achieve long- and short term University and department goals and plans. Work with leadership on short- and long-term critical issues, projects, plans, and University strategic goals without supervision. * Develop, disseminate, and approve standard operating procedures, guidelines, policies, processes, protocols and training programs for operation and compliance within the department. * Monitor and research developments in federal and state laws and regulations that have an impact on clinical research agreements and 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. * Manage the regular publication of summary reports and serves as an information resource to coworkers, the university, and external figures. * Create a cohesive work team that works collaboratively to achieve unit's goals. 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. * 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. * Performs other related duties as assigned. *MINIMUM QUALIFICATIONS* *Education:*Bachelor's degree in discipline appropriate to position required. Masters preferred. *Experience: *Seven (7) years of related experience in public health, clinical research, clinical trials, law, or related field with at least five (5) years of operations or compliance experience. May have expertise within specialty of unit. *Supervisory Experience:*Four (4) years of direct management of recruitment, training, and professional development of staff. Directly responsible for the performance of management and staff. *Certification/Licensure:*N/A *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. In instances where specific education and/or experience is required only directly related education and/or experience may be substituted. ** *KNOWLEDGE, SKILLS, 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. *KNOWLEDGE, SKILLS, AND ABILITIES* • Collaboration with Principal Investigators (PIs): Demonstrated ability to work closely with PIs to develop and implement clinical research protocols, ensuring alignment with departmental goals and regulatory standards. • Sponsor Engagement: Experience in liaising with research sponsors, including pharmaceutical companies and grant agencies, to facilitate funding, negotiate contracts, and maintain positive relationships that support ongoing and future research initiatives. • Multi-Site Staff Oversight: Proven leadership in managing clinical research teams across multiple sites, ensuring consistent study execution, data integrity, and adherence to protocols. This includes coordinating activities among various locations to maintain uniform standards and practices. • Regulatory Compliance: In-depth knowledge of institutional policies and federal regulations governing clinical research, such as Good Clinical Practice (GCP) guidelines and FDA requirements. The candidate should ensure all research activities comply with these standards to protect patient safety and data validity. • Operational Excellence: Strong organizational and problem-solving skills to oversee the day-to-day operations of clinical trials, including budgeting, resource allocation, and timeline management, ensuring studies are completed efficiently and effectively. • Communication Skills: Excellent interpersonal and communication abilities to effectively interact with diverse stakeholders, including researchers, clinical staff, sponsors, and regulatory bodies, fostering a collaborative research environment *HIRING RANGE:*$144,000 - $160,000 per year (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. For assistance related to employment, please contact the Staffing department atHRJobs@umaryland.edu. 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 aUMB Job Applicant Accommodation Request. You may also contactHRDiversity@umaryland.edu. Please note that only inquiries concerning an ADA request for reasonable accommodation will be responded to from this email address. 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. For more information, follow this link UMB Notice of Non-Discrimination. **Job:** **Reg or CII Exempt Staff* **Organization:** **School of Medicine - Radiation Oncology* **Title:** *Director, Clinical Research Operations & Compliance* **Location:** *null* **Requisition ID:** *2500002G*
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