Clinical Research Program Lead

About the role

The Clinical Research Program Lead will manage the clinical research study team, providing training, mentoring, management of workload assignments, and oversight of coordinator responsibilities. They will be responsible for all aspects of hiring, onboarding, and training and will provide coverage during absences. They will take a leadership role in strategizing the direction of growth for the team, initiating new projects and processes, developing study documents and staff resources, managing the detailed operations of the studies, and coordinating activities with internal and external partners.

Responsibilities

• Manage the clinical research study team, providing training, mentoring, management of workload assignments, and oversight of coordinator responsibilities.
• Hire, onboard, and train staff.
• Provide coverage during absences.
• Strategize the direction of growth for the team, initiate new projects and processes, develop study documents and staff resources, manage detailed operations of the studies, and coordinate activities with internal and external partners.
• Develop, create, and review study source documents, regulatory submissions, annual reports, and training documents, as applicable.
• Ensure studies are conducted safely and according to the protocol while maintaining quality control and meeting milestones.
• Oversee the start-to-end processes for study start-up and ongoing study management, including study feasibility and selection, prioritization of the study team's work, and facilitating timely study closure.
• Work closely with the business office to oversee the finances of the department and work on study budgets and invoicing.

Qualifications

• Bachelor's Degree with 5-7 years of related experience or equivalent combination of education and experience is required.
• Master's degree and 3-5 years of experience preferred.
• Demonstrated complex problem solving abilities.
• Excellent communication and writing skills.
• Strong organizational and time management skills.
• Flexible, detail-oriented, organized, and able to multi-task.
• Demonstrated ability to work as part of a team, as well as independently.
• Strong innovative skills.
• Able to work collaboratively on all levels and to gain support of others.
• Able to develop interdepartmental relationships and form solid collaborations.
• Able to confidently interact with all levels of management including senior management, physician leaders, and others.
• Knowledge of IRB and human research protection regulations.