Sub-Investigator (PRN)-MD or NP

Job Description

Job Description

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).
• 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.
• Ensure Protocol Compliance
• Ensure Adequate Review by A Duly Constituted Institutional Review Board (IRB)
• 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.
• Protect the Rights and Welfare of Subjects
• Ensure Validity of The Data Reported to The Sponsor
  • Ensure the accuracy, completeness, legibility, and timeliness of case report forms.
  • Explain any discrepancies between source documents and case report forms.
• Ensure Documentation of Study-Related Procedures, Processes and Events
• Ensure the Proper Use and Storage of Investigational Agents
• Direct Site Operations
  • Communicate effectively with subjects, research team, IRB, and sponsor.
• Maintains Professional and Technical Knowledge

Skills and Qualifications:

• Education and experience
  • If an MD, must be board certified in the state of FL and have an active license; if an NP, must have an active nursing license for the state of FL and have an MSN or DNP.
  • Experience as a Sub-Investigator in industry-sponsored clinical trials highly preferred.
• Requirements
  • Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
  • Knowledgeable in medical terminology
  • Skilled in persuading potential sponsors to place research with the site.
  • Demonstrate the initiative to act independently, initiate activity as required and make appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.
  • Able to initiate or modify behavior to achieve desired outcomes despite environmental factors, priorities, or problems that might not be well defined or that are subject to change.
  • Experienced negotiation skills
  • Excellent persuasive/selling skills.
    Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.
  • Excellent communication skills (interpersonal, written, verbal)
  • Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)