2 Clinical Research Coordinator II Jobs in Lakewood, FL
Florida Research Institute is Hiring a Clinical Research Coordinator II Near Lakewood, FL
- 401(k)
- 401(k) matching
- Competitive salary
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Job Summary:
Duties Include but are not limited to:
- Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
- Obtain informed consent
- 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:
- Create source 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
- Four years of Clinical Research Coordinator experience
License/Certification
- GCP
- Research Professional Certificate – CCRC or exam eligibility preferred
Job Summary
Full Time
Business Services
$54k-72k (estimate)
06/01/2024
07/31/2024
floridaresearchinstitute.org
Bradenton, FL
<25
Business Services
Related Companies
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