CenExel Clinical Research is seeking a Principal Investigator to conduct clinical trials in accordance with research protocol, Good Clinical Practices (GCPs), and federal/state regulations. The ideal candidate will have a valid M.D. or D.O. degree, board certification, and 1-3 years of experience conducting clinical research trials.
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
- Ensure 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
