Job Posting for Clinical Research Coordinator II at Digestive and Liver Center of FL
This position is responsible for performing highly diverse clinical and administrative responsibilities requiring a high level of knowledge and attention to detail. This position requires assimilating vast amounts of information and processing information promptly and orderly. Personnel who fill this role must have a working knowledge of ICH/GCP guidelines. Specific studies are assigned as appropriate, and the coordinator is accountable to the Principal Investigator, Medical Director, and Clinical Research Manager.
Qualifications
1 years of previous experience required as a clinical research coordinator for pharmaceutical phase II or III trials, GI trials
Computer skills - Microsoft Word, Excel, PowerPoint, CTMS, EMR
Previous experience in a role of complex administration or project coordination
Effective communication skills, including written, verbal, and presentation skills
Strong attention to detail and organizational, analytical, and problem-solving skills
Periodic local travel to other practice locations on an as-needed basis
Supervisory Responsibilities
This position may serve a role in supporting/ mentoring junior coordinators and research assistants
Job Duties/Responsibilities
Ensure the rights, safety and welfare of all subjects at all times
Ensure that each subject goes through the informed consent process following GCP guidelines, and consents to participate, before any study-related procedures are performed
Work in a collaborative, effective manner with the Sponsor personnel to meet research objectives completely and accurately
Work in a collaborative, effective manner with Site personnel to meet research objectives completely and accurately
Responsible for understanding all internal policies and procedures approved by the Principal Investigator/Medical Director
Discuss study protocols with patients and verify informed consent documentation
Review patient medical history against Inclusion/Exclusion Criteria of studies
Perform blood draws, process and shipping of blood/urine specimens per study protocol and IATA regulations
Schedule all patient research visits and procedures consistent with protocol requirements
Dispense study medication, collect vital signs, and perform ECGs
Assist with routine data verification and quality control, ensuring data integrity and consistency with the prescribed study protocol
Provide the Sponsor with accurate and complete documentation and information
Provide accurate and complete documents for IRB submission on a timely basis
Complete and maintain accurate, legible and complete source documents and case report forms per FDA guidelines and Sponsor requirements
Retain and/or forward copies of forms as required by the Sponsor
Inform Sponsor of prospective FDA audits immediately
Prepare for FDA or Sponsor audit by ensuring all documentation and case report forms are available and complete
Provide subject education on an ongoing basis throughout their participation in the study
Report all adverse events to the Investigator, Sponsor and IRB.
Complete Study Logs in an accurate and timely manner in the appropriate electronic data system
Utilize a team approach including the PI, Sub-Investigators, other Coordinators and Research Assistant
Assist in the training of new staff members
Other duties as assigned
Job Type: Full-time
Pay: $23.00 - $27.00 per hour
Benefits:
401(k)
401(k) matching
Dental insurance
Health insurance
Paid time off
Vision insurance
Experience level:
1 year
2 years
3 years
Schedule:
Monday to Friday
Ability to Commute:
Orlando, FL 32825 (Required)
Ability to Relocate:
Orlando, FL 32825: Relocate before starting work (Required)
Work Location: In person
Salary.com Estimation for Clinical Research Coordinator II in Orlando, FL
$82,848 to $110,434
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