Job DescriptionSummaryResponsible for directing and managing a specified program within the clinical research operations unit, department, or division. Provides leadership, guidance, and direction for day-to-day clinical research operations and activities, including authority to make independent decisions regarding program operations, administration, and governance. Ensures compliant, efficient, and effective conduct of clinical trials within the portfolio. Establishes, implements, and evolves operational standards and monitors quality and progress of the program(s). A program is an ongoing organizational initiative with defined objectives and scope, but without a defined end or completion date.
Duties and Responsibilities- Oversee and/or manage an assigned organizational clinical research program with authority for day-to-day operations and administration. May be responsible for program development or expansion. Plan and implement program operations, determine and develop governance, processes, and guidelines, coordinate program activities and timelines, and organize resources to meet program objectives.
- Manage the research study intake process, including feasibility review, endorsement, PRMC submission, and tracking of trials declined by program or department leadership.
- Identify logistics, action items, operational changes, and information needed to effectively manage the program. Identify barriers to study activation and efficient coordination and implement solutions. Lead cross-functional teams in program administration, maintenance, and expansion.
- Partner with internal and external stakeholders, departments, organizational leaders, and external agencies to provide guidance, resolve issues, grow the program, and implement processes and solutions.
- Identify growth opportunities and operational efficiencies. Support development of strategic plans to achieve program objectives. Evaluate study feasibility and provide recommendations or decisions that support program success. Maintain and strengthen stakeholder relationships, community outreach efforts, and program development initiatives.
- Research and analyze data to evaluate program performance, quality assurance, and trends. Make recommendations and implement improvements based on findings. Provide data summaries to stakeholders, leadership, and cross-functional teams. Perform quality oversight of clinical trials, including monitoring screening, enrollment, data submission, protocol compliance, and staff training.
- Plan and support audit preparation and required follow-up activities.
- Evaluate requests for program exceptions or changes and determine appropriate responses, escalating when necessary.
- Assess communication and training needs and develop communication, education, onboarding, mentorship, and training programs. Provide regular updates to departments and leaders and communicate program changes to stakeholders.
- In partnership with leadership, plan, monitor, and manage program budgets and financial performance and resolve or escalate issues as appropriate.
- Maintain data system integrity and ensure adherence to quality assurance standards and departmental procedures. Provide ad hoc reporting and trend analysis to support future planning and enhancements.
- Monitor program governance and compliance with local, state, and federal regulations, accreditation standards, regulatory agency requirements, licensure requirements, organizational policies, and procedures. Monitor compliance reporting tools and provide status reports to leadership and stakeholders.
- Manage staff and/or lead the work of others, including recruitment, onboarding, offboarding, training, performance management, professional development, and competency assessment.
Department-Specific Responsibilities- Manage Disease Research Group (DRG) meetings and ensure all necessary information is available to support DRG operations.
- Communicate regularly with DRG faculty and engage physicians, advanced practice providers, clinic nurses, and staff to address clinical research issues in a timely and compliant manner.
- Promote and advance clinical research activities in a safe, compliant, effective, efficient, and collaborative manner.
- Manage and oversee training and education of clinical research staff. Conduct competency assessments, identify development opportunities, create training plans, support continuing education, and oversee ongoing staff development.
- Contribute to the development and execution of educational programs supporting high-quality clinical research.
- Support development, implementation, monitoring, and documentation of corrective action plans and ensure compliance with organizational and departmental policies and procedures.
- Participate in strategic planning activities and represent the Clinical Trials Office on committees and task forces as assigned.
- Independently coordinate studies, including patient screening, eligibility review, informed consent participation, study oversight, staff supervision, enrollment strategies, training, and identification of research opportunities.
- Ensure compliance with all federal, regulatory, FDA, IRB, and local requirements.
- Coordinate study participant tests and procedures, serve as a liaison among study participants, Principal Investigators, and research staff, and manage research specimens as required.
- Perform phlebotomy services in accordance with organizational policies and procedures, including specimen verification, identification, labeling, quality assessment, result reporting, and patient confidentiality requirements.
- Perform other duties as assigned.
Teamwork, Customer Relations, and Leadership Responsibilities- Establish effective working relationships with cross-functional teams.
- Respond timely, effectively, and appropriately to deliverables and organizational needs.
- Share knowledge, expertise, and time to support team success.
- Build and maintain strong relationships with stakeholders, customers, and client groups.
- Ensure practices and procedures support interpersonal and cultural inclusivity.
- Identify and respond appropriately to internal and external customer needs using available resources.
- Collaborate to solve problems and make decisions that achieve desired outcomes.
- Act as a team lead by overseeing the work of others, assigning responsibilities, and ensuring work is completed according to quality standards and deadlines.
QualificationsREQUIRED- High School Diploma/GED
- 5 years of management, program management, project management, or related experience
- 1 year of experience managing the operations of a clinical trial
PREFERRED- Bachelor's Degree in Healthcare, Management, or a related field
- 3 years of related experience in the area of specialization within a clinical research or industry setting
