ERG is the largest independent clinical research site services company focused on special populations and is the market leader in CNS.? With 12 wholly owned clinical sites and 12 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. Our mission is to provide the highest quality execution of clinical trials in all clinical research phases aimed at helping sponsor companies to get their life saving or life enhancing drugs to market as quickly and safely as possible.?
We are seeking an individual that will be responsible for the overall coordination, organization, management, and efficient implementation of clinical trials as a Clinical Research Coordinator. They will complete all study related procedures and distributes study medication and instructions to research subjects under the direction of the Principal Investigator and the Site Director. Maintain accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Research Coordinator is guided FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.
Obtains 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.
Reviews 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.
Manages studies with the sponsor, Site Director, and Principal Investigator to ensure compliance with protocol requirements.
Manages studies with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment.
Serves 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.
Contribute to the SOP review and development as delegated by the Site Director.
Perform study activities as delegated by the Principal Investigator and under the supervision of the Site Director.
Attends the investigator meeting for each assigned protocol, as appropriate.
In conjunction with Site Director and Principal Investigator, ensure adherence to the protocols and document breaches or violations with sponsors and appropriate Institutional Review Boards (IRBs) and other outside regulatory organizations, as required.
Screen, enroll subjects and schedule subject visits in conjunction with Principal Investigator
Review and obtain informed consent from with potential study volunteers (only the PI’s do that at FLCR)
Document all written and phone correspondences with sponsor, labs, IRB other regulatory organizations
Maintain organized, accurate and complete study records and regulatory documents
Assist Principal Investigator in conducting studies to ensure integrity of data and safety of subjects.
Enter data as appropriate for protocol (paper-electronic data capture)
In conjunction with Principal Investigator, accurately report and track adverse events as defined by each study protocol
Perform study close-out procedures
Store study records appropriately
Skills and Qualifications
1 year of clinical research experience is preferred
High School Diploma or its equivalent; College degree preferred.
Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines.
Knowledgeable in medical terminology
Excellent communication skills (interpersonal, written, verbal)
Ability to perform overnight business travel
Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)
About Neuropsychiatric Research Center of Southwest Florida
Evolution Research Group, LLC is the largest independent clinical research site services company focused on special populations and is the market leader in CNS. With 12 wholly owned clinical sites and 7 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG is recognized for execution excellence and quality and continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally.