Clinical Research Project Lead
About The Position
We are seeking a Clinical Research Program Lead who will be responsible for the overall management of the observational research portfolio and associated research activities of the Parkinson's Disease and Movement Disorders Center (PDMDC), part of the Department of Neurology. This center is located at Pennsylvania Hospital. 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, on boarding, 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. They will develop, create, and review study source documents, regulat01y submissions, annual reports, and training documents, as applicable. They will also develop and maintain standard operating procedures for the team. They will ensure that studies are being conducted safely and according to the protocol while maintaining quality control and meeting milestones. They will oversee the start-to-end processes for study start-up and ongoing study management. This includes assisting with study feasibility and selection, prioritization of the study team's work, working closely with the study team and investigators to manage, review, and initiate studies/trials to ensure competitive activation and enrollment timelines as well as facilitate timely study closure. They will work closely with the business office to oversee the finances of the department and work on study budgets and invoicing.
Requirements
- Bachelor's Degree with 5-7 years of related experience or equivalent combination of education and experience is required.
- 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.
Nice To Haves
- Master's degree and 3-5 years of experience preferred.
Responsibilities
- Manage the clinical research study team, providing training, mentoring, management of workload assignments, and oversight of coordinator responsibilities.
- Responsible for all aspects of hiring, on boarding, and training and will provide coverage during absences.
- 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.
- Develop, create, and review study source documents, regulatory submissions, annual reports, and training documents, as applicable.
- Develop and maintain standard operating procedures for the team.
- Ensure that studies are being 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.
- Assist with study feasibility and selection, prioritization of the study team's work, working closely with the study team and investigators to manage, review, and initiate studies/trials to ensure competitive activation and enrollment timelines as well as facilitate timely study closure.
- Work closely with the business office to oversee the finances of the department and work on study budgets and invoicing.
- Report directly to the Director, Parkinson Foundation Center of Excellence, Parkinson's Disease and Movement Disorders Center, and indirectly to the other investigators within the team.
- Collaborate closely with the Clinical Research Program Lead of the PDMDC Clinical Trials team as well as with external departments/stakeholders to support day to day operations of the study team.
Benefits
- Excellent healthcare
- Tuition benefits for employees and their families
- Generous retirement benefits
- Wide variety of professional development opportunities
- Supportive work and family benefits
- Wealth of health and wellness programs and resources
- Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits
- Flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars
- Tuition assistance for employee, spouse, and dependent children
- Generous retirement plans (Basic, Matching, and Supplemental)
- Substantial amount of time away from work
- Long-Term Care Insurance
- Wellness and Work-life Resources
- Professional and Personal Development resources
- Access to a wide range of University resources as well as cultural and recreational activities
- Discounts and Special Services (arts and entertainment, transportation, mortgages, new cars, cellular phone service plans, movie tickets, theme parks)
- Flexible work options
- Penn Home Ownership Services (forgivable loan for eligible employees)
- Adoption Assistance
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
