Clinical Research Coordinator II Center for Interventional Endoscopy

Clinical Research Coordinator II - AdventHealth Orlando

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*

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 : Days, M-F, 7am - 4pm (flexible)

Location: 601 EAST ROLLINS STREET, Orlando, 32803

The community you'll be caring for: 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

The role you'll contribute:

The Clinical Research Coordinator II (CRC II) 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 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 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.

The value you'll bring to the team:

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.

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

• Minimum qualifications :
  • Bachelor's Degree and 2 years of experience in clinical research or
  • Associates degree 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.

• Preferred qualifications:

o Master's degree in Healthcare, Research or related field

o Experience in area of specialty, as assigned

o Certified Clinical Research Coordinator (CCRC) (per the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA)

o American Heart Association Basic Life Support (BLS)

o American Heart Association Advanced Cardiovascular Life Support (ACLS)

o Other certification as applicable to degree or program (i.e. medical assistant, medical technician, phlebotomy)

2/28/22