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Clinical Research Coordinator II (Non-RN) at AdventHealth Orlando
Location Address: 601 E ROLLINS ST, Orlando, 32803
Top Reasons to work at AdventHealth Orlando :
Located on a lush tropical campus, our flagship hospital, 1,368-bed AdventHealth Orlando
Serves as the major tertiary facility for much of the Southeast, the Caribbean and South America
AdventHealth Orlando houses one of the largest Emergency Departments and largest cardiac catheterization labs in the country
We are already one of the busiest hospitals in the nation, providing service excellence to more than 32,000 inpatients and 125,000 outpatients each year
Work Hours/Shift: FT Days
You Will Be Responsible For:
· 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.
· 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:
EDUCATION AND EXPERIENCE REQUIRED:
KNOWLEDGE AND SKILLS REQUIRED:
· Ability to work independently in a fast-paced clinical or research environment, handling
· Interpersonal communication skills; ability to interact and maintain good relationships with a broad spectrum of healthcare disciplines and the public under all circumstances
· Detail oriented and has teamwork skills; motivated, organized, ability to perform multiple tasks in a timely manner, and work efficiently under pressure
· Simultaneously executes and coordinate multiple clinical trials and function independently; perform diverse clinical and clerical duties
· Specialized knowledge of the unique needs of patients undergoing treatment in research trials including device management trials
· Ability to be a critical thinker with an analytical approach to problem-solving
· Minimum of two to five years leveraging knowledge of human life sciences/biomedical research; physiological, cellular, biochemical, or molecular biology
· Minimum two to five years understanding and leveraging of standard clinical practices with regard to informed consent, biospecimen collection, and handling
· Working knowledge of Microsoft Office applications, such as, Word, Excel, Access, Outlook, and Internet knowledge and skill
EDUCATION AND EXPERIENCE REQUIRED:
· Bachelor’s Degree in Healthcare Administration, Research, or related field and 2 years of experience in clinical research or
· Associates degree in Healthcare Administration, Research, or related field and 4 years of experience in clinical research or related field or
· Graduate of an accredited allied health certificate program with six (6) years of clinical research or healthcare experience.
KNOWLEDGE AND SKILLS PREFERRED:
· Bilingual (Spanish)
· 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 PREFERRED:
· Master’s degree in Healthcare Administration, Research, or related field
· Experience in area of specialty, as assigned
LICENSURE, CERTIFICATION OR REGISTRATION PREFERRED:
· 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 degree or program (i.e. medical assistant, medical technician, phlebotomy)
The Clinical Research Coordinator II (Non-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 (Non-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 (Non-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
At AdventHealth, Extending the Healing Ministry of Christ is our mission. It calls us to be His hands and feet in helping people feel whole. Our story is one of hope — one that strives to heal and restore the body, mind and spirit. Our more than 80,000 skilled and compassionate caregivers in hospitals, physician practices, outpatient clinics, urgent care centers, skilled nursing facilities, home health agencies and hospice centers are committed to providing individualized, wholistic care.