Clinical Research Coordinator-FT CRC

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 Clinical Research Coordinator II is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. The CRC II completes all study related procedures and distributes study medication and instructions to research subjects under the direction of the Principal Investigator and the Site Director. They maintain accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Research Coordinator is guided by FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.

Responsibilities : General

• Obtain detailed knowledge of all components of each study protocol through review and analysis of study information with Principal Investigator and Site Director prior to the effective date of the study.
• Develop draft source documents and review the documents for accuracy and clarity prior to study start up.
• Develop a mechanism for subject recruitment and ongoing communications with PCP and nursing staff as appropriate.
• Review with Principal Investigator and Site Director, any components of the study for which additional information or clarification are required prior to the initiation of the study.
• Manage studies with sponsor, and Principal Investigator to ensure compliance with protocol requirements.
• Manage studies with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment.
• Serve as a mentor and trainer for support staff and new employees once the Clinical Research Coordinator has been approved to do so by the Site Director.
• Communication of all protocol related issues / problems to the appropriate management staff, including but not limited to questions regarding the conduct of the clinical trial.
• Contribute to the SOP review and development as delegated by the Site Director.

Study Management

Skills and Qualifications :

High School Diploma or its equivalent; College degree preferred.

Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.