Clinical Research Coordinator II RN Pediatrics FT Days
Location Address: 601 E Rollins St, Orlando, FL 32803
Top Reasons to work at AdventHealth Orlando
Work Hours/Shift: Full Time, Days; 40 hours/week
You Will Be Responsible For:
The Clinical Research Coordinator II RN (CRC-II RN) serves the AdventHealth Research Institute (AHRI), under limited supervision, to plan, coordinate, evaluate and perform the nursing care of participants and collect data for assigned research projects. The CRC-II RN follows study specific protocol guidelines, communicates with AHRI Principal Investigators (PI), Sub-Investigators (Sub-I), Clinical Research Lead and clinical research support staff. The CRC-II RN works to advocate for the patient, while adhering to the conduct of industry-sponsored and investigator-initiated clinical trials in accordance with trial protocols, Food and Drug Administration (FDA) regulations and International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines.
Works closely with AHRI Core managers to schedule clinical operations to facilitate the initiation and completion of clinical research studies. Promotes Principal Investigator (PI) oversight by advising the PI, sub-investigator(s), Lead and Director of deviations in conduct, patient status, issues relevant to the integrity of the trial and/or the safety of research subjects; abides by hospital and departmental policies and SOPs, as well as all applicable local, state, and federal regulations
Serves as liaison between Principal Investigators and the Institutional Review Board (IRB) and the Office of Sponsored Programs (OSP). Prepares all documentation for clinical research purposes as may be required by Principal Investigators to track all submissions to IRB and OSP, and will meet all reasonable
deadlines for submission. Tracks all submissions to IRB and OSP, and maintains timely turnaround of all documents to avoid delays in study initiation and/or progress.
Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.
PRINCIPAL DUTIES AND JOB RESPONSIBILITIES:
• Delivers safe care and demonstrates regard for the dignity and respect of all participants. Maintains adequate skills in clinical competencies including but not limited to physical assessment, phlebotomy and IV insertion. Practices the principles of Universal Precautions. Understands and abides by HIPAA regulations.
• Maintains a clean, prepared clinical space. May perform set-up and turnover procedures in all clinical areas, per SOP’s, in a timely manner.
• Participates in internal and/or external training programs to maintain licensure.
• Utilizes positive interpersonal communication skills; communicates effectively with members of the healthcare team, patients, investigators, sponsors of research and administration.
• Reviews all elements of the current institutional IRB approved informed consent (IC) document, according to current FDA, state, federal and institutional regulations with study candidates and/or legal representative; ensures, through patient advocacy and informed consent as an ongoing process, that the rights, safety and well-being of trial subjects are the most important considerations and should prevail over the interests of science and society. (Add from Chart)
• Manages multiple clinical trial protocols, coordinates the execution and follow-up of each protocol, seeks and utilizes resources and works independently; performs accurate, legible and timely documentation. Manages records, study medication and test articles in confidential and secure manner.
• Promotes Principal Investigator (PI) oversight by advising the PI, sub-investigator(s), Supervisor and/or Clinical Operations Manager of deviations in conduct, patient status, issues relevant to the integrity of the trial and/or the safety of research subjects; abides by hospital and departmental policies and SOPs, as well as all applicable local, state, and federal regulations.
• Coordinates the work of support staff, laboratory technicians, and assistants to ensure efficient, timely, and high-quality results and adherence to research protocols.
• Serves as liaison between Principal Investigators and the Institutional Review Board (IRB) and the Office of Sponsored Programs (OSP). Prepares and/or reviews all required documentation for clinical research study start up, execution, modification, renewal, and termination and will meet all reasonable deadlines for submission. Maintains timely turnaround of all documents to avoid delays in study initiation and/or progress. Remains current on rapidly changing regulatory requirements and HIPAA regulations and implements these changes as appropriate and in a timely manner.
• Collaborates with study sponsors. Assists site monitors during their visits in a professional manner.
• Works flexible hours and is available as a resource for questions related to research projects.
• Performs other duties as assigned or directed to ensure smooth and efficient operations of the FHRI and Core. Communicates the need for new work and automatically looks for additional duties as workload permits.
What You Will Need:
KNOWLEDGE AND SKILLS REQUIRED:
KNOWLEDGE AND SKILLS PREFERRED:
• Demonstrated proficiencies in clinical study coordination across a spectrum of trial acuities.
• Knowledge of Federal regulations: Food and Drug Administration (FDA), Centers for Disease Control (CDC), Department of Health and Human Services (DHHS)
• Bilingual (English/Spanish)
EDUCATION AND EXPERIENCE REQUIRED:
EDUCATION AND EXPERIENCE PREFERRED:
LICENSURE, CERTIFICATION OR REGISTRATION REQUIRED:
LICENSURE, CERTIFICATION OR REGISTRATION PREFERRED: