Sub l /Nurse Practitioner

About Company:

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.

Job Description:

The Sub-Investigator acts as the secondary physician in charge of medical and clinical issues at the clinical research site, acting in place of the Principal Investigator, as requested, or required. Works with the Principal Investigator and the site to evaluate clinical trials and ensure that all study-related procedures are completed properly from a clinical and a regulatory perspective.

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 Sub-Investigator is guided by and promotes the adherence to Good Clinical Practices (GCP), International Committee on Harmonization (IHP) guidelines, and company standard operating procedures and policies.

Responsibilities:

Planning and Management

• Assist in recruitment of additional research studies, especially through professional/clinical, and industry relationships.
• Provide input to the Principal Investigator and/or Site Director about study protocols (e.g., with respect to enrollment/retention potential, office capacity and capabilities, profit potential, and other determinants of success).
• Provide input to the Principal Investigator and/or Site Director as to which studies to pursue.
• Conduct medical office visits with subjects in active studies and ensure compliance with requirements of protocols for said studies.
• Act as liaison with study monitors for active studies.
• Represents ERG at conferences sponsored by potential clients (i.e., pharmaceutical firms) as requested.
• Aid Patient Recruitment personnel in recruiting patients for studies, with a particular emphasis upon working with other physicians and hospitals.
• Ensure proper compliance and execution of the Informed Consent processes.

Investigator Qualifications and Agreements

• Maintain a current, up to date curriculum 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 clinical investigation.
• Assume responsibility for the conduct of the clinical investigation.
• Sign the Form FDA 1572 as appropriate.
• Sign the protocol as required.
• Sign sponsor contract(s) as appropriate
• Disclosing conflicts of interest as described in the regulations.

Ensure Protocol Compliance

• Possess a thorough understanding of the requirements of each protocol.
• Participate in sponsor investigator meetings whenever possible.
• Determine that inclusion/exclusion criteria are applicable to the study population.
• Ensure recruitment goals are reasonable and attainable.
• Follow the trial's randomization procedures.
• 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.

Ensure Adequate Review by A Duly Constituted Institutional Review Board (IRB)

• Provide the IRB with adequate information to initially review the study (i.e., protocol, investigator's brochure, informed consent form, recruitment advertisements and any written information to be given to subject(s)
• Provide the IRB with documents for ongoing review (i.e., amendments to the protocol, adverse events, deviations, or new information)
• Secure written IRB approval prior to initiating the study or instituting any changes to the protocol as approved.
• Provide written summaries of the trial status to the IRB annually, or as requested.
• Provide the IRB with all documents subject to their review.

Manage the Care of Subjects

• Assess subject compliance with the test article and follow-up visits.
• Assess subject's response to therapy.
• Evaluate adverse experiences per protocol guidelines.
• Ensure that medical care is provided to a subject for any adverse event(s)
• Inform a subject when medical care is needed to treat an intercurrent illness(es)
• Inform the subject's primary physician about their participation in the trial.