Principal Investigator/Physician

Responsible for conducting clinical trials in accordance with the research protocol, Good Clinical Practices (GCPs), and federal/state regulations. Generates independent, high quality, and reproducible results.

Requirements

• Maintain current license to practice medicine.
• Maintain current board certification, if applicable
• Assume responsibility as the Principal Investigator for the duration of clinical trials
• Strong working knowledge of regulatory requirements and GCP standards
• Possess thorough understanding of the clinical research protocol and patient population for which the trial is designed
• Ensures recruitment goals are reasonable and attainable
• Perform any evaluations deemed necessary for the conduct of the trial
• Complete training as required per sponsor’s vendors to obtain certification to conduct testing and rating scales for specific protocols
• Conduct testing and rating scales per sponsor’s instructions and protocols
• Evaluate participants for clinical research trials based on their past medical history in comparison to the protocol specific inclusion and exclusion criteria
• Ensure appropriate delegation and training of the clinical research staff
• Educate study staff on patient population and mechanism of action of the investigational product
• Evaluate subject safety and compliance with the investigational product as specified in the clinical research protocol as well as collaborate with the medical director
• Assess participant’s response to investigational therapy and evaluate any adverse events
• Adhere to reporting requirements for safety reports, protocol noncompliance and any other protocol required reports
• Ensure subject’s informed consent is obtained appropriately throughout the duration of the clinical trial
• Adhere to the requirements detailed on the FDA 1572 or Statement of Investigator form
• Collaborate with Site Leadership to ensure company goals are met
• Provides key budgetary decisions and verifies that appropriate budgets and cost projections are prepared to deliver the proposed project scope
• Attend Investigator Meetings and educational seminars.
• Assumes other duties and responsibilities as assigned.

Benefits

• Health Insurance
• Dental
• Vision
• LTD
• STD
• Life Ins
• 401k