General Description: Leads Life Extension Clinical Research and ensures studies are conducted in a timely, quality driven manner while following all applicable guidelines. This role is responsible for the day-to-day operations of Life Extension Clinical Research, including managing clinical studies (onsite and virtual) with a sense of urgency, within budget and with the goal of creating a Clinical Center of Excellence.
Core Duties and Responsibilities:- Provides overall leadership to LECR and staff by clearly communicating goals and expectations and driving productivity with a sense of urgency while ensuring 100% compliance with rules and regulations.
- Ensure all clinical trial projects (internal and external), to include project management, tracking and reporting trial progress and monitoring test item expiration dates in relation to project timelines
- Management and oversight of research projects and laboratory components of studies; develops appropriate study design and establishes accurate timelines; collaborates on statistical plans and data analysis
- Prepares and/or supervises the preparation of the Protocol, Informed Consent and associated documentation for clinical studies and assures necessary project approvals from an Institutional Review Board (IRB) are obtained
- Primary point of contact for the IRB
- Prepares and manages all LE Clinical Research budgets
- Sets priorities for all staff to assure project timelines are met, including active promotion of clinical research initiatives, i.e. use of social media
- Assures all applicable regulations are implemented and followed; supervises management of data files and confidential information; follows established SOPs, i.e. for appropriate document destruction
- Responds to inquiries from individuals seeking funding or product donations, and if warranted, presents project and recommendations to administration
- Monitors progress of ongoing external projects that received Life Extension support and/or donated materials, assuring resupply so materials do not expire without replacement during a project
- Supports the study team with the various tasks associated with conducting the clinical trial to ensure goals are met
- Seeks out ways to employ innovative technology to optimize organization and individual efficiency and performance
- Proactively drives the effort to achieve the goal of creating an impactful Clinical Center of Excellence.
- Hires, trains and assures high quality supervision of the LE clinical research staff
- 2 onsite days per week is an essential function of this position with flexibility to work additional onsite days as needed
- Travels as needed
- Additional duties as assigned
Position Requirements:- Bachelor's degree in Biomedical Science, Healthcare or a Life Science related field required; Advanced degree (MSN/NP, MD, DO, PharmD, MHSA, PhD) preferred
- 7+ years Clinical Research experience with at least 2 years in a supervisory leadership capacity preferred
- Demonstrated leadership, ability to effectively communicate and drive positive change
- Equally adept at running traditional in person and innovative virtual clinical studies.
- Proactively manage LECR and readily adapt to and incorporate new technologies and platforms
- Successfully multi-task in an entrepreneurial environment and manage multiple clinical studies in parallel
