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About the Role

The Clinical Research Coordinator is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. This role involves completing study procedures, distributing study medication, and maintaining accurate participant records, all while adhering to FDA regulations, GCP, and company SOPs.

Responsibilities

• Obtain detailed knowledge of all study protocol components.
• Assist in developing and reviewing draft source documents.
• Review study components with Principal Investigator and Site Director for clarification.
• Manage studies under the oversight of Site Director and Principal Investigator to ensure protocol compliance.
• Develop effective study enrollment programs with Principal Investigator, Site Director, and Recruitment Manager.
• Contribute to SOP review and development.
• Perform study activities as delegated by the Principal Investigator and supervised by the Site Director.
• Attend investigator meetings for assigned protocols.
• Ensure adherence to protocols and document breaches with sponsors and IRBs.
• Screen, enroll subjects, and schedule visits.
• Review and obtain informed consent from potential study volunteers.
• Document all written and phone correspondences with sponsors, labs, and regulatory organizations.
• Maintain organized, accurate, and complete study records.
• Assist Principal Investigator in conducting studies to ensure data integrity and subject safety.
• Enter data using appropriate methods (paper-electronic data capture).
• Accurately report and track adverse events.
• Perform study close-out procedures.
• Store study records appropriately.
• Perform additional responsibilities as required by organizational needs.

Requirements

• Understand regulatory requirements, Good Clinical Practices (GCP), and International Conference of Harmonization (ICH) guidelines.
• Excellent communication skills (interpersonal, written, verbal).
• Basic computer skills including Word, Excel, and proprietary clinical research applications.

Skills

• Medical terminology
• Independent initiative and decision-making
• Adaptability to changing priorities and problems

Education Level

• High School Diploma or equivalent
• College degree preferred

Benefits

• Medical and dental coverage
• Matching 401(k)
• Paid time off

About the 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.
• We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders.