Principal Investigator, Clinical Trials; PRN

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PRN CPMI-Clinical Pharmacology Miami, Miami, FL, US

30+ days ago Requisition

Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.

Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.

The Principal Investigator ensures adherence to protocol requirements, protecting the rights and welfare of study subjects, assuring the integrity of data generated at the site. In executing these position responsibilities, the Investigator is guided by and promotes the adherence to FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.

• Work with the Site Director and Medical Director to provide oversight of Sub-Investigator. Review work to ensure adherence to SOPs, ICH GCP guidelines, and protocol requirements.

• Work with Site Director, Study Coordinator, and Recruitment Manager to develop effective programs for studyenrollment.
• Work with Site Director to ensure that all staff are adequately trained and adhere to Standard Operating Procedure and working guidelines while performing study procedures on assigned studies.
• Work with the Site Director to ensure the site has an adequate number of qualified staff, adequate facilities, and that the PI has adequate time to conduct thestudy.

• Maintain a current, up to datecurriculum vitae.
• Maintain current licensure to practice.
• Provide the sponsor and IRB with documentation of credentials as requested.
• Demonstrate the proper education, training, and experience to conduct the clinicalinvestigation.
• Assume responsibility for the conduct of the clinicalinvestigation.
• Sign the Form FDA 1572 as appropriate.
• Sign the protocol as required.
• Sign sponsor contract(s) as appropriate
• Document the financial aspects of the trial
• Disclosing conflicts of interest as described in theregulations.

• Possess a thorough understanding of the requirements of eachprotocol.
• Participate in sponsor investigator meetings whenever possible.
• Determine that inclusion/exclusion criteria are applicable to the studypopulation.
• Ensure recruitment goals are reasonable and attainable in conjunction with the Site Director
• Assess overall protocol feasibility in conjunction with the Site Director
• Follow the trial's randomizationprocedures.
• Will not implement any protocol deviation or changes without agreement by the sponsor and prior review and approval by the IRB (except to eliminate immediate hazards to the subject)
• Review the inclusion /exclusion criteria, schedule of visits, end point criteria and investigational article use with the research team.

• Provide the IRB with adequate information to initially review the study (i.e., protocol, investigator's brochure, informed consent…