Clinical Research Coordinator (CRC)-FT Position Available In Lee, Florida

Clinical Research Coordinator (CRC)-

FT Title:

Clinical Research Coordinator (CRC)

Location:

NPRC-Fort Myers, FL 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.

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.
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.
Completion of IRB study renewals and maintain copies of all IRB communications.
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 potential study volunteers.
Document all written and phone correspondences with sponsor, labs, IRB other regulatory organizations.
Maintain organized, accurate and complete study records including but not limited to regulatory documents, signed informed consents, IRB correspondence/approvals, source documentation, drug dispensing logs, subject logs and study-related communications.
Assist Principal Investigator in conducting studies in manner to ensure integrity of data and safety of subjects.
Ensure timely and accurate CRF completion for each study subject.
In conjunction with Principal Investigator, accurately report and track adverse events as defined by each study protocol.
Outcome of enrollment and sponsor monitoring visits of all assigned protocols
Perform study close-out procedures.

Skills and Qualifications:

Education and experience
High School Diploma or its equivalent; College degree preferred.
Two (2) to four (4) years of experience OR certification as a Clinical Research Coordinator
Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.
Knowledgeable in medical terminology so as to communicate with physician office and laboratory staff.
Demonstrate the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.
Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change.
Requirements
Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
Excellent communication skills (interpersonal, written, verbal)
Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager) Clinical Research Coordinator (CRC)-FT

EVOLUTION RESEARCH GROUP

Fort Myers, FL
Full Time Published on 04/19/2025