Clinical Research Nurse - 257535

The GI Clinical Research Nurse delivers safe care and demonstrates regard for the dignity and respect of all trial participants. Located in Orlando, FL (32804), this role supports clinical trial operations within an established program, splitting time between the primary research office and the clinical facility located directly across the street. The position focuses on industry-sponsored Phase II–IV treatment trials, predominantly in adult Gastroenterology and Inflammatory Bowel Disease (IBD). The GI Clinical Research Nurse maintains clinical competencies including physical assessment, phlebotomy, IV insertion, and administration of investigational biological/infusion treatments and injections. Performs clinical, administrative, and trial coordination duties in accordance with organizational policies, Universal Precautions, and HIPAA regulations.

Work Location & Schedule

• Location: Orlando, FL (32804) – On-site role split between main office location and clinic facility across the street.
• Schedule: Monday through Friday, 8:00 AM – 5:00 PM (with flexibility as needed for research project requirements).

Key Responsibilities

• Oversee and execute clinical protocol requirements for Phase II–IV industry-sponsored treatment trials, primarily supporting adult patients with Inflammatory Bowel Disease (IBD) and related GI conditions.
• Split time efficiently between office-based administrative/coordination tasks and clinic-based patient care across the street.
• Administer investigational products, including IV infusions, subcutaneous injections, and related drug therapies; perform clinical tasks such as phlebotomy, IV placement, and physical assessments.
• Assist physicians, Advanced Practice Registered Nurses (APRNs), and clinical research staff with minor procedures and study-specific protocols within the scope of practice.
• Review informed consent documents with candidates, ensuring patient advocacy, safety, and compliance.
• Serve as a primary liaison between Principal Investigators (PIs), the Institutional Review Board (IRB), study sponsors, site monitors, and internal administrative departments.
• Maintain PI oversight by actively reporting protocol deviations, adverse events, patient status updates, and overall trial integrity.
• Coordinate the activities of laboratory technicians, research assistants, and support staff to ensure quality control and protocol adherence.
• Maintain clinical research spaces, preparing equipment, handling specimen processing, and conducting room turnover procedures.
• Maintain active nursing licensure through internal and external continuing education programs.

Knowledge, Skills, and Abilities

• Strong clinical background in IV insertion, phlebotomy, and complex drug administration (infusion and injection protocols).
• In-depth understanding of standard clinical research practices, including informed consent processes, biospecimen collection, storage, and handling.
• Working knowledge of federal research regulations and governing bodies (FDA, CDC, DHHS).
• Ability to manage multiple trial protocols simultaneously while split across office and clinic settings in a fast-paced environment.
• Excellent interpersonal, verbal, and written communication skills to engage effectively with patients, multidisciplinary teams, sponsors, and auditors.
• Proficiencies in standard office software (word processing, spreadsheets, databases, email applications).

Qualifications

Education:

• Associate’s Degree in Nursing (Required)
• Bachelor’s Degree in Nursing (Preferred)

Work Experience:

• Minimum 2+ years of clinical research experience (Required)
• Experience in Gastroenterology (GI), specifically Inflammatory Bowel Disease (IBD) (Preferred)
• Demonstrated experience with Phase II–IV industry-sponsored clinical trials (Preferred)
• Background leveraging human life sciences, biomedical research, or related physiological disciplines (Preferred)

Licenses and Certifications:

• Registered Nurse (RN) License (Required)
• Basic Life Support (BLS) / CPR Certification (Required)
• Advanced Cardiac Life Support (ACLS) Certification (Preferred)
• Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) (Preferred)

Additional Preferences:

• Grant writing or professional medical writing experience (Preferred)