Clinical Research Nurse

About Rare Disease Research:

As an independent clinical research site, we are 100% dedicated to conducting clinical research, accelerating the development of safe and effective treatments and providing rare disease patients with access to innovative investigational therapies. We are a passionate, caring, multi-disciplinary team conducting clinical research with expertise and compassion, and always to the highest ethical standards.

About This Opportunity:

We are looking for an RN who has at least 1 year experience with the conduct of clinical research to join our wonderful team of motivated research professionals. The right candidate will have prior clinical research experience conducting investigational clinical trials and is already familiar with clinical research workflows, regulatory requirements, and data collection and documentation practices.

* Important Note: Applicants for employment in the United States must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Rare Disease Research.

Responsibilities:

Participant Safety & Regulatory Compliance

• Assist the Principal Investigator (PI) and Sub-Investigator (Sub-I) in protecting the rights and welfare of human research participants in accordance with federal regulations, IRB policies, and sponsor requirements.
• Review and maintain a strong working knowledge of study protocols, including timelines, visit schedules, inclusion/exclusion criteria, and confidentiality protections.
• Escalate safety concerns to the PI/Sub-I and document adverse events, concomitant medications, and other safety-related data per protocol.
• Participate in audit preparation and corrective action implementation.
• Ensure accurate and complete study documentation, including consent forms, source documents, narrative notes, case report forms, and investigational product accountability.

Study Conduct & Participant Care

• Conduct daily participant visits, including triage, assessments, and coordination of the clinic whiteboard and room assignments.
• Perform phlebotomy, IV/port access, infusion administration, ECGs, vital signs, and protocol-required safety/efficacy assessments.
• Follow participants from screening to study completion, providing ongoing communication and education.
• Support anesthesia and procedural visits by obtaining consent, collecting medical history, assisting with procedures, and reporting to anesthesia providers.
• Set up, assist with, and provide education for muscle biopsy procedures; monitor participants post-biopsy or post-anesthesia, including site assessment and redressing.
• Conduct gene therapy–specific unit orientation for patients/families regarding PPE, infection control, restroom use, and unit expectations.

Clinic & Laboratory Operations

• Prepare patient rooms daily and maintain cleanliness and organization of the clinic and nurse station.
• Oversee lab cleanliness, the lab operations schedule, and coordinate closely with CRCs and Research Assistants.
• Perform weekly eyewash station flushing and maintain daily freezer/refrigerator temperature logs.
• Maintain clinical laundry processes, including double-laundering linens exposed to gene-therapy-related biohazards.
• Manage stock checks, restocking, and removal of expired supplies; ensure proper inventory levels for all clinical and lab materials.

Gene Therapy Safety & Oversight

• Train staff on Personal Protective Equipment (PPE), hazardous exposure protocols, biohazardous waste procedures, and room cleaning standards.
• Supervise gene therapy cleanings and ensure proper execution by CRCs and RAs; coordinate terminal cleaning with appropriate personnel.
• Notify internal and external partners (e.g., Pro-Disposal) for biohazard pickup and supply replenishment.

Supply Chain & Equipment Management

• Manage procurement of medications and clinical supplies for Georgia, North Carolina, and Florida sites (McKesson, Medline, etc.).
• Maintain blood analyzer equipment and ensure functional readiness of other clinic devices (ECGs, autoclave, Hoyer lift, etc.).
• Maintain provider compliance and registrations for programs such as REMS, DEA renewals, McKesson/CSOS access.

Training, Collaboration, & Communication

• Train CRCs, RAs, and new staff on clinical procedures (vital signs, ECGs, Hoyer use, autoclave operation, blood analyzers).
• Collaborate with PI, Sub-I, CRCs, RAs, pharmacy, regulatory staff, medical assistants, and physical therapy to ensure smooth execution of study visits.
• Develop and maintain study-specific training documentation and help onboard personnel involved in study conduct.
• Communicate professionally and promptly with sponsors, CROs, and vendors.
• Participate in daily problem-solving and operational decision-making, exercising independent judgment and discretion.

Data & Documentation Management

• Ensure timely data entry, query resolution, and accurate chart binder maintenance.
• Coordinate source documentation completion with delegated staff and maintain all study records in accordance with sponsor and institutional requirements.

The above statements are intended only to describe the general nature of the job, and should not be construed as an all-inclusive list of position responsibilities.

Job Type: Full-time

Pay: $70,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Experience:

• Registered nurse: 3 years (Required)
• Pediatrics: 2 years (Required)
• Clinical trials: 1 year (Required)

Ability to Relocate:

• Brookhaven, GA 30329: Relocate before starting work (Required)

Work Location: In person

Salary : $70,000 - $90,000