Senior Clinical Research Associate
Kerr Dental
Google Cloud Platform
Senior Medical Director
Elligo Health Research
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Serve as Principal Investigator (PI) / Sub-Investigator (Sub-I) on Elligo Decentralized Clinical Trials; responsible for the conduct of clinical trials as per GCP/HSP guidelines to ensure participant safety and data integrity
- Lead clinical research programs as an Investigator across multiple therapeutic areas and provide strategic medical leadership for Decentralized Clinical Trials (DCT)
- Provide thorough review of protocol and other study materials and determine clinical and practical fit for practice partner sites
- Collaborate with leadership, Feasibility, Operations, site operations, data management, and regulatory teams to ensure high-quality trial execution and patient safety
- Provide therapeutic and protocol specific training and supporting material for project teams and local investigators; prepare risk assessments and participate in recruitment/enrollment strategy development
- Serve as senior medical expert for ongoing trials, providing oversight on safety data, eligibility, and protocol adherence
- Foster and maintain relationships with sponsors, CROs, key opinion leaders, and outside medical experts; participate in technology and strategic committees
- Promote a culture of scientific excellence, monitor employee productivity, provide feedback and coaching, and assess staff performance
- Ensure adherence to Elligo, Clinic, and Sponsor policies, SOPs, GCP guidelines, and ALCOA documentation standards
- Participate in high-level strategy discussions guiding the future direction of decentralized clinical research and perform other duties as required
Requirements
- MD, DO degree required form a U.S. accredited Medical School
- Active Medical Board Certification is required
- Current and Active license to practice medicine in the U.S.
- Eight (8) or more years of healthcare experience in a U.S. community practice setting
- Minimum two (2) years of experience FDA clinical research as a Principal or Sub-Investigator
- Fully GCP trained and able to explain the importance of GCP guidelines to staff
- Expert knowledge of legal and ethical standards for the delivery of medical care
- Expertise regarding applicable compliance requirements including quality, safety, and/or infection control standards
- Ability to clearly explain and enforce clinical research participant safety requirements including safety reports, ICF elements, and role of the IRB
- Demonstrated ability to work collaboratively with cross functional departments/groups and different levels of employees
- Proven ability to lead cross-functional teams and manage complex clinical programs
- Strong scientific, analytical, problem-solving, organization, prioritization, written and verbal communication, and interpersonal skills
- Demonstrated proficiency with MS Office (Outlook, Word, Excel, PowerPoint, SharePoint) and clinical trial master filing systems and eSource
- Knowledge of related accreditation and certification requirements, including ongoing engagement in maintenance of certification for primary board certification
- Ability to travel for Clinic activities, and attend investigator meetings or vendor visits/audits, as required
