Clinical Research Coordinator II Tri ResearchOrlando, FL

Clinical Research Coordinator II AdventHealth Orlando

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.

With a variety of Orlando hospital jobs, we invite you to start or elevate your career with a new job at AdventHealth Orlando. We constantly seek out Orlando nurses, medical assistants, nurse assistants, patient care and health administration professionals who share our passion for whole-person health care. Learn more about our open positions and apply to become an invaluable part of our team.

Every day, our fellow team members show up to work, unified by one shared mission: Extending the Healing Ministry of Jesus Christ. As a faith-based health care organization, our story is one of hope as we strive to heal and restore the body, mind and spirit. Though our facilities are spread across the country, this unwavering belief binds us together. Across every office, exam and patient room, we're committed to providing individualized, holistic care. This is our Christian mission, and it inspires us to help make communities healthier and happier.

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.

The expertise and experiences you'll need to succeed:

Minimum qualifications:

Bachelors 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:

Masters degree in Healthcare, Research or related field

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)

American Heart Association Basic Life Support (BLS)

American Heart Association Advanced Cardiovascular Life Support (ACLS)

Other certification as applicable to 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.