The Clinical Research Coordinator III RN serves AdventHealth Research Institute (AHRI) providing oversight of 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. Functions as a clinical study coordinator for strategically aligned clinical projects and initiatives for the clinical research units they serve. Works closely with Supervisor and AHRI Core Managers to develop systems and processes that facilitate the initiation and completion of clinical research studies. Collaborates with AdventHealth Research Services teams to ensure smooth operations. Actively participates in outstanding customer service and accepts responsibility for maintaining relationships that are equally respectful to all.
PRINCIPAL DUTIES AND JOB RESPONSIBILITIES:
Â· 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.
Â· Maintains a clean, prepared clinical space. May perform set-up and turnover procedures in all clinical areas, per SOPâ™s, in a timely manner.
Â· Participates in internal and/or external training programs to maintain licensure.
Â· Provides effective and compliant clinical research study coordination, including planning, organizing, and managing all study activities related to clinical research operations and execution of timelines.
Â· As directed, leverages clinical expertise to develop and implement processes and procedures to ensure workflow is optimized while meeting quality standards. Interfaces with AHRI Cores as study coordinator to ensure initiation and completion of industry-sponsored and investigator-initiated clinical trials.
Â· Serves as a preceptor for all new study coordinators, including the development of training processes and material.
Â· Provides guidance and mentorship to promote growth for study team members, including those in new positions.
Â· Assists in establishing and maintaining Standard Operating Procedures (SOPs) for AdventHealth Research Institute clinical operations, research training, and certification for staff.
Â· Identify, develop and/or participates on special projects for the efficient operations of clinical research areas.
Â· Assists in the development of approaches to monitor and evaluate the quality and safety of clinical operations at AHRI.
Â· Supports the delivery of safe care with regard for the dignity and respect for all patients/participants.
Â· Performs other duties as assigned or directed to ensure smooth and efficient operations of AHRI.
KNOWLEDGE AND SKILLS REQUIRED:
Â· Ability to perform clinical tasks including assisting physician, ARNP and CRN with minor procedures and other study requirements within scope of practice.
Â· Ability to acclimate and integrate into various clinical settings as needed per protocol
Â· Demonstrated skills in clinical competencies including physical assessment, phlebotomy, IV insertion and administration of investigational drugs in accordance with AdventHealth Policies and Procedures.
Â· Demonstrated proficiencies in clinical study coordination across a spectrum of trial acuities.
Â· Knowledge of Federal regulations: Food and Drug Administration (FDA), Centers for Disease Control (CDC), Department of Health and Human Services (DHHS)
Â· Ability to work independently in a fast-paced clinical or research environment
Â· Interpersonal communication skills; ability to interact and maintain good relationships with a broad spectrum of healthcare disciplines and the public under all circumstances
Â· Detail oriented and has teamwork skills; motivated, organized, ability to perform multiple tasks in a timely manner, and work efficiently under pressure
Â· Simultaneously executes and coordinate multiple clinical trials and function independently; perform diverse clinical and clerical duties
Â· Specialized knowledge of the unique needs of patients undergoing treatment in research trials including device management trials
Â· Ability to be a critical thinker with an analytical approach to problem-solving
Â· Minimum of two to five years leveraging knowledge of human life sciences/biomedical research; physiological, cellular, biochemical, or molecular biology
Â· Minimum two to five years understanding and leveraging of standard clinical practices with regard to informed consent, biospecimen collection, and handling
Â· Working knowledge of Microsoft Office applications, such as, Word, Excel, Access, Outlook, and Internet knowledge and skill
KNOWLEDGE AND SKILLS PREFERRED:
EDUCATION AND EXPERIENCE REQUIRED:
Â· Minimum 4 years of Clinical Research experience
Â· Experience in areas of specialty, as assigned
EDUCATION AND EXPERIENCE PREFERRED:
LICENSURE, CERTIFICATION OR REGISTRATION REQUIRED:
Â· Current, active State of Florida license as a Registered Nurse
Â· Certified Clinical Research Coordinator (CCRC) (per the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA))
LICENSURE, CERTIFICATION OR REGISTRATION PREFERRED:
Â· Advanced Cardiovascular Life Support (ACLS)
Â· Other certification as applicable to clinical degree or program (i.e. medical assistant, medical technician, phlebotomy)