What are the responsibilities and job description for the Clinical Research Coordinator position at Evolution Research Group?
About Company : Who is ERG?
ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late-stage neuroscience drug development. With 19 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340 in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients / subjects and 5000 completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally.
About the Role :
As a Clinical Research Coordinator (CRC), you will play a pivotal role in coordinating, organizing, and managing clinical trials to ensure seamless execution. Reporting to the Principal Investigator and Site Director, you will oversee study procedures, provide medication and instructions to study participants, and maintain precise, confidential documentation. This role adheres strictly to FDA regulations, Good Clinical Practice (GCP), and ERG's standard operating procedures (SOPs).
Responsibilities :
- Gain comprehensive knowledge of study protocols through collaboration with the Principal Investigator and Site Director prior to study activation.
- Develop, review, and refine source documents for clarity and accuracy before study launch.
- Design and implement a recruitment strategy, coordinating with primary care providers and nursing staff as needed.
- Address protocol components that require further clarification with the Principal Investigator and Site Director.
- Collaborate with the sponsor and Principal Investigator to ensure protocol compliance and manage study-related tasks.
- Work with the Recruitment Manager to create effective enrollment programs.
- Contribute to the development and review of SOPs as directed by the Site Director.
- Execute study activities as assigned by the Principal Investigator and supervised by the Site Director.
- Handle IRB study renewals and maintain organized records of all IRB communications.
- Ensure strict adherence to study protocols, reporting any protocol deviations or violations to the necessary regulatory bodies.
- Screen and enroll study subjects, coordinating visits with the Principal Investigator.
- Obtain informed consent from study volunteers and document all interactions with sponsors, labs, IRBs, and other regulatory bodies.
- Maintain complete, accurate study records, including regulatory documents, consent forms, IRB correspondence, drug dispensing logs, and other study-related materials.
- Perform study close-out procedures and store records appropriately.
- This role may involve additional duties as needed to align with ERG's mission and goals.
Minimum Qualifications :
Preferred Qualifications :
Benefits Overview :
Our comprehensive benefits package includes :
