Rn, Clinical Research Coordinator Ii

All the benefits and perks you need for you and your family:

• Benefits from Day One
• Paid Days Off from Day One
• Student Loan Repayment Program
• Career Development
• Whole Person Wellbeing Resources
• Mental Health Resources and Support
• Pet Insurance
• Debt-free Education* (Certifications and Degrees without out-of-pocket tuition expense)

Our promise to you:
Joining AdventHealth is about being part of something bigger. It's about belonging to a community that believes in the wholeness of each person, and serves to uplift others in body, mind and spirit. AdventHealth is a place where you can thrive professionally, and grow spiritually, by Extending the Healing Ministry of Christ. Where you will be valued for who you are and the unique experiences you bring to our purpose-minded team. All while understanding that together we are even better.
Schedule: Full-Time / Shift : Day (M-F 8:30a.m. to 4:30p.m.)
Location: 601 E ROLLINS ST, Orlando, 32803
The community you'll be caring for: Insert Marketing Statement
The role you'll contribute:
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.
The value you'll bring to the team:

• 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.

Qualifications
The expertise and experiences you'll need to succeed:
Required:

• Associate degree in Nursing
• Minimum 2 years of Clinical Research experience
• Current, active State of Florida license as a Registered Nurse
• BLS Certification