Clinical Research Coordinator II

Florida Research Institute; Town of Florida (NY); On-site; USD 60,000 - 90,000; Full time

Job summary

The Florida Research Institute (FRI) seeks a Clinical Research Coordinator (CRC) II to screen, enroll, and monitor study participants, ensuring protocol and regulatory adherence across trials. The role includes interaction with sponsors and CROs and representing FRI in the community.

Responsibilities span performing visits, collecting samples, handling ECGs, reviewing results, managing data entry to CRFs, and ensuring timely adverse event reporting, with a focus on accuracy and patient safety.

Qualifications

• 2+ years of clinical research experience
• GCP knowledge and regulatory familiarity
• Familiar with FDA regulations and ICH guidelines
• Strong written and verbal communication
• Proficient in MS Word and Excel

Responsibilities

• Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
• Complete visit procedures and ensure proper specimen collection processing and shipment in accordance with protocol
• Be prepared to complete basic clinical procedures, such as blood draws, vital signs, and ECGs
• Review laboratory results, ECGs, and other test results for completeness and alert values, ensure investigator review in a timely fashion
• Recognize Adverse Events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator
• Schedule patients within visit windows
• Dispense study medication per protocol and or IVRS system. Educate subject on proper administration and importance of compliance
• Monitor subject progress on study medication
• Record data legibly, in real time on source documents
• Accurately record study medication inventory, medication dispensation, and patient compliance
• Accurately transcribe data to CRFs. Resolve data management queries and correct source data as needed
• Record protocol exemptions and deviations as appropriate with sponsor
• Maintain copies of patient-specific correspondence in source charts
• Assist regulatory personnel with completion of continuing/final review reports

Skills

Medical terminology

GCP knowledge

Communication

Interpersonal skills

Electronic data capture

MS Word

MS Excel

Independent work

Tools

Clinical trials database

Electronic data capture (EDC)

IVRS system

Data transcription to CRFs

MS Word

Job description

Clinical Research Coordinator (CRC) II is primarily responsible for screening, enrolling, and monitoring study participants to ensure protocol and regulatory requirements compliance. At Florida Research Institute (FRI), the CRC II will have an increased workload and overall responsibility for studies, as well as enhanced interaction with sponsors and Contract Research Organizations (CROs). This role involves representing FRI positively to the community, sponsors, CROs, study participants, and their family members.

Duties Include but are not limited to :

• Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
• Complete visit procedures and ensure proper specimen collection processing and shipment in accordance with protocol
• Be prepared to complete basic clinical procedures, such as blood draws, vital signs, and ECGs
• Review laboratory results, ECGs, and other test results (e.g., MRI and Biopsy reports) for completeness and alert values, ensure investigator review in a timely fashion
• Recognize Adverse Events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator
• Schedule patients within visit windows
• Dispense study medication per protocol and or IVRS system. Educate subject on proper administration and importance of compliance
• Monitor subject progress on study medication

Documentation:

• Record data legibly, in real time on source documents
• Accurately record study medication inventory, medication dispensation, and patient compliance
• Accurately transcribe data to CRFs. Resolve data management queries and correct source data as needed
• Record protocol exemptions and deviations as appropriate with sponsor
• Maintain copies of patient-specific correspondence in source charts
• Assist regulatory personnel with completion of continuing/final review reports

Knowledge, Skills, and Abilities

• Excellent working knowledge of medical and research terminology
• Extensive working knowledge of federal regulations, Good Clinical Practices (GCP)
• Ability to communicate and work effectively with a diverse team of professionals
• Strong computer skills with demonstrated abilities using clinical trials database, electronic data capture, MS Word and Excel
• Excellent interpersonal skills, detailed-oriented and meticulous
• Ability to work independently in a fast-paced environment with minimal supervision

Education and Experience

• 2+ years of clinical research experience

License/Certification

• GCP
• Research Professional Certificate – CCRC or exam eligibility preferred