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About the Role

This role is responsible for advising and managing a specified program within the clinical research operations unit, department, or division. The incumbent will provide leadership, mentorship and direction for the day-to-day clinical research operations and activities, including authority to make independent decisions regarding program operations, administration, and governance. This position ensures compliant, efficient, and effective conduct of the clinical trials within the portfolio. The incumbent stablishes, implements, and evolves operational standards and monitors quality and progress of the program(s).

This role will help establish a clinical research program, manage research staff members, and will provide oversight with daily operations. The position will work closely with the Director of the Pancreatic and Biliary Diseases Program.

Note: A program is an ongoing organizational initiative with defined objectives and scope, but without a defined end or completion date.

Primary Duties and Responsibilities:

• Coordinates and/or manages the assigned recognized organizational clinical research program and has authority for day-today program operations and administration. May be responsible for program development or expansion. Plans and implements program operations, determines and develops governance, processes and/or guidelines, coordinates program activities and timelines, and determines and organizes resources to meet program objectives.
• May manage the research study intake process, including feasibility, review and endorsement and PRMC submission, as well as capturing all trials declined by program or department leadership.
• Identifies and defines any logistics, action items, changes, or information needed to effectively manage the program. Identifies barriers to timely study activation, efficient coordination, and participate to identify/implement solutions. May identify program participants and lead cross-functional teams in the administration, maintenance or expansion of the program.
• Collaborate with internal and external key partners including other departments, leaders across the organization, representatives from external agencies/organizations in the management of the program to provide guidance, resolve issues, grow the program, and/or implement processes and/or solutions.
• Identifies growth opportunities and further efficiencies that impact the program and/or departments success and aids in development of strategic plans to achieve objectives. Manages study intake process, evaluates feasibility, and providing recommendations or making decisions to support the success of the clinical research program. Works with internal/external collaborators to maintain and further develop program growth, community outreach activities, as well as relationship development and maintenance.
• Researches and analyzes data for evaluating performance of program or program operations, including quality assurance and trends. Makes recommendations to leadership and/or implements program changes based on findings. Provides data and/or summary findings to program participants, collaborators, leadership, and/or cross-functional teams. Performs quality oversight of clinical trials to include supervising progress of screening, enrollment, and data submission. Responsible for ensuring protocol compliance and training of staff supporting the program.
• Plans and supports the department/program leaders during an audit, to include direction for audit prep and any required follow-up post audit.
• Evaluates requests for program exceptions or changes, and resolves, calling out as vital.
• Assesses communication and training needs, develops and implements any applicable communication, education, training, on-boarding and/or mentorship pertaining to the program. Provides routine communication to departments and leaders across the organization. Notifies collaborators of any changes to the program. May work with cross-functional teams across multiple departments to develop communication and training materials.
• In conjunction with leadership, responsible for planning, monitoring, and managing program fiscal budgets and financials, and resolves issues.
• Maintains data system integrity and ensures quality assurance measures are followed based on departmental standard operating procedures. May provide ad hoc reporting to support recommendations observed through trend analysis for future planning and improvements.
• Monitors program to ensure appropriate governance and program compliance with local, state and federal laws; accreditation, professional and regulatory agency standards and licensure requirements. Maintains staff and program compliance with organizational policies and procedures. Monitors compliance reporting tools and provides summary status reports to the Research Manager, and other collaborators.
• May manage staff and/or lead the work of others, including some or all of the following: recruitment, on-boarding/offboarding, training, performance management and professional development of staff.

Education:

• High School Diploma/GED required.
• Bachelor's degree preferred.

Licenses/Certifications:

SOCRA/ACRP certification required to be acquired within the first year of employment.

Experience:

• 5 years management, program or project management, or related experience required.
• 3 years related experience in the area of specialization within clinical research or industry setting required.
• 1 year experience managing the operations of clinical trials is highly preferred.

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