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Medical Research Director

2 months ago

Nashville, Tennessee, United States K2 Medical Research Full time
Job Title: Principal Investigator

We are seeking a highly skilled and experienced Principal Investigator to lead our clinical trials team at K2 Medical Research.

Job Summary:

The Principal Investigator will be responsible for overseeing the conduct of clinical trials, ensuring adherence to protocol requirements, protecting the rights and welfare of study subjects, and directing the conduct of the clinical investigation according to federal and state regulations and guidance documents.

Key Responsibilities:
  • Ensure accurate documentation of study-related procedures
  • Ensure proper use and storage of Investigational Product
  • Monitor all safety variables, including adverse events, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medications as per protocol, and un-blinding requests
  • Review, approve and ensure timely reporting of eCRFs, protocol deviations and Serious Adverse Events (SAE)
  • Meet with FDA, IRB, Sponsors, CROs, or their delegated representatives as needed throughout the study
  • Review and discuss any medical or protocol-related concerns with medical monitors
  • Attend Investigator Meetings and other study-related meetings
  • Review and approve Clinical Study Agreements
  • Work with Sub-investigator(s), Clinical Research Coordinators, and key study personnel in overseeing the execution of study protocols
Requirements:
  • Medical Degree and broad-based post-graduate experience
  • Doctor's License within the State of Rhode Island
  • A minimum of 3 or more years of experience in a clinical research position
  • Principal Investigator of Clinical Trials: 3 years (Required)
What We Offer:

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.