AdventHealth
Clinical Research Coordinator II RN OncologyOrlando, FL
AdventHealth, Orlando, Florida, us, 32885
Clinical Research Coordinator Ii - Rn
At AdventHealth Orlando, what started as a converted farmhouse in rural Central Florida has become Central Florida's major tertiary health care facility. Patients come from the Southeast, the Caribbean and even as far as South America for our proven expertise and compassionate health care. 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. 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 SOPs, 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. 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. Minimum qualifications: Associate degree in Nursing Minimum 2 years of Clinical Research experience Current, active State of Florida license as a Registered Nurse BLS Preferred qualifications: Bachelor's degree in Nursing Experience in area of specialty, as assigned Certified Clinical Research Coordinator (CCRC) (per the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA)) Advanced Cardiovascular Life Support (ACLS) Other certification as applicable to clinical degree or program (i.e. medical assistant, medical technician, phlebotomy) This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances. Category: Research Organization: AdventHealth Orlando Schedule: Full-time Shift: 1 - Day Req ID: 25036771 We are an equal opportunity employer and do not tolerate discrimination based on race, color, creed, religion, national origin, sex, marital status, age or disability/handicap with respect to recruitment, selection, placement, promotion, wages, benefits and other terms and conditions of employment.
At AdventHealth Orlando, what started as a converted farmhouse in rural Central Florida has become Central Florida's major tertiary health care facility. Patients come from the Southeast, the Caribbean and even as far as South America for our proven expertise and compassionate health care. 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. 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 SOPs, 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. 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. Minimum qualifications: Associate degree in Nursing Minimum 2 years of Clinical Research experience Current, active State of Florida license as a Registered Nurse BLS Preferred qualifications: Bachelor's degree in Nursing Experience in area of specialty, as assigned Certified Clinical Research Coordinator (CCRC) (per the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA)) Advanced Cardiovascular Life Support (ACLS) Other certification as applicable to clinical degree or program (i.e. medical assistant, medical technician, phlebotomy) This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances. Category: Research Organization: AdventHealth Orlando Schedule: Full-time Shift: 1 - Day Req ID: 25036771 We are an equal opportunity employer and do not tolerate discrimination based on race, color, creed, religion, national origin, sex, marital status, age or disability/handicap with respect to recruitment, selection, placement, promotion, wages, benefits and other terms and conditions of employment.