Clinical Research Coordinator

About the company

Evolution Research Group (ERG) runs Phase I through Phase IV clinical trials with a focus on moving important therapies to patients safely and efficiently. Established in 2014, the organization has become a prominent neuroscience-focused clinical development group, supported by affiliate locations across the United States and strong capabilities in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic conditions. ERG has supported more than 5,000 trials and is continuing to broaden its work in demanding therapeutic areas in the U.S. and worldwide.

The company emphasizes a collaborative environment, meaningful work, and the chance to contribute to advanced research alongside experienced industry professionals. Benefits mentioned include medical and dental coverage, a matching 401(k), and paid time off.

Role overview

The Clinical Research Coordinator is accountable for organizing, coordinating, and efficiently carrying out clinical trials. This person completes study-related procedures and provides study medication and instructions to research participants under the supervision of the Principal Investigator and Site Director. The role also requires careful handling of confidential participant records and compliance with FDA rules, Good Clinical Practice (GCP), and company policies and standard operating procedures.

Key responsibilities

• Build a thorough understanding of each protocol by reviewing the study details with the Principal Investigator and Site Director before the study begins.
• Help prepare source documents and check them for accuracy and clarity before study initiation.
• Work with the Principal Investigator and Site Director to resolve any study details that need further explanation prior to launch.
• Oversee studies under the direction of the Site Director and Principal Investigator to keep work aligned with protocol requirements.
• Partner with the Principal Investigator, Site Director, and Recruitment Manager to support effective enrollment planning.
• Assist with SOP review and updates when assigned by the Site Director.
• Carry out study tasks assigned by the Principal Investigator while working under Site Director supervision.
• Attend investigator meetings for assigned protocols when directed.
• Coordinate with the Site Director and Principal Investigator to ensure protocol compliance and report any deviations or violations to sponsors, IRBs, and other regulatory bodies when needed.
• Screen and enroll participants and arrange study visits with the Principal Investigator.
• Obtain informed consent from prospective study volunteers.
• Record all written and telephone communication with sponsors, labs, IRBs, and other regulatory organizations.
• Keep study files organized, accurate, complete, and securely stored.
• Support the Principal Investigator in conducting studies in a way that protects subject safety and preserves data quality.
• Enter protocol data in paper or electronic capture systems as required.
• With the Principal Investigator, monitor and document adverse events according to the protocol.
• Complete study close-out activities.
• Store study documentation properly.
• Take on additional duties as the organization’s needs change, since the role may expand or be adjusted over time.

Qualifications and requirements

• High school diploma or equivalent is required; a college degree is preferred.
• Strong interpersonal, written, and verbal communication skills are needed to work effectively with providers, colleagues, sponsors, and others.
• Working knowledge of medical terminology is important for communication with physician offices and laboratory staff.
• Ability to work independently, take initiative, and make sound decisions within protocol, compliance, and company policy limits.
• Comfort adapting behavior and priorities to meet changing circumstances and uncertain situations.
• Understanding of regulatory expectations, Good Clinical Practices (GCP), and International Conference of Harmonization (ICH) guidance is required.
• Basic computer literacy, including Word, Excel, and clinical research software such as Study Manager, is needed.

Benefits

• Medical coverage
• Dental coverage
• Matching 401(k)
• Paid time off

Additional information

This position is based in Miami, Florida and is a full-time onsite role. The description also notes that responsibilities may change or expand depending on evolving business needs.