Principal Investigator - Clinical Trials
Company: K2 Medical Research
Location: Nashville
Posted on: October 16, 2024
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Job Description:
The Medical Doctor (PI) promotes Good Clinical Practice in the
conduct of clinical investigations by ensuring adherence to
protocol requirements, protecting the rights and welfare of study
subjects, assuring the integrity of data generated at the site and
directing the conduct of the clinical investigation according to
federal and state regulations and guidance documents. Primary
Responsibilities: The PI assumes full responsibility for a clinical
trial, including the oversight and ethical conduct of the study,
maintaining integrity of the study design, and direction of the
research team to ensure research is conducted in accordance with
the local and national laws and regulations, including applicable
FDA regulations, GCP, ICH guidelines, HIPAA, and all policies and
procedures of the Sponsor, CRO and Site Evaluate patient
eligibility for a clinical trial as per protocol Review and discuss
study protocols and obtain (or delegate) informed consents from
patients Meet with patients during designated study visits to
perform assessments, including physical examinations and data
collection Review and interpret laboratory results, EKGs and other
diagnostic and safety assessments as required per study protocol
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 Use proper medical judgment in the interpretation and
decision-making as it relates to the investigational study Review,
approve and ensure timely reporting of eCRFs, protocol deviations
and Serious Adverse Events (SAE) Ensure accurate documentation of
study-related procedures Ensure proper use and storage of
Investigational Product Ensure prompt reporting all unanticipated
problems or injuries to IRB, Sponsor, or delegated representative
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 Other
duties as assigned Knowledge, Skills, Abilities: Broad knowledge of
general medicine Strong analytical and problem-solving skills
Excellent organizational skills, detail oriented, efficient, and
able to multi-task and prioritize effectively Excellent
interpersonal skills Strong written and verbal communication skills
Qualifications: Medical Degree and broad-based post-graduate
experience Doctor's License within the State of Tennessee A minimum
of 3 or more years of experience in a clinical research position
Principal Investigator of Clinical Trials: 3 years (Required)
Employment Type: Full Time Bonus/Commission: No
Keywords: K2 Medical Research, Hendersonville , Principal Investigator - Clinical Trials, Healthcare , Nashville, Tennessee
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