Location:

This role is onsite at our site, Clinical Pharmacology of Miami, in Miami, FL 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.

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:

The Clinical Research Coordinator is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. The CRC 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.
Assist to develop draft source documents and review the documents for accuracy and clarity prior to study start up.
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 direct oversight from Site Director, 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.
Contribute to the SOP review and development as delegated by the Site Director. Study Management
Perform study activities as delegated by the Principal Investigator and under the supervision of the Site Director.
Attend the investigator meeting for each assigned protocol, as appropriate with directive from Site Director.
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 volunteer
Document all written and phone correspondences with sponsor, labs, IRB other regulatory organizations
Maintain organized, accurate and complete study records
Assist Principal Investigator in conducting studies in manner 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
Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization.

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Clinical Research Coordinator