Summary:

The Clinical Research Nurse collaborates closely with the Principal Investigator to oversee study execution from selection to closeout. Ensuring adherence to Good Clinical Practice (GCP) and relevant regulations, this role upholds the quality and integrity of assigned clinical studies.

Duties/Responsibilities:

• Manage all study aspects, including protocol adherence, GCP compliance, and coordination of study visit procedures.
• Participate in the informed consent process and oversee Investigational Product and study-related supplies.
• Assist with monitoring visits, attend Investigator Meetings, and contribute to query resolution.
• Provide exceptional care and customer service to study participants.
• Serve as a knowledgeable clinical resource for the team.
• Ensure proper dispensing, accountability, and return of study drug as per protocol.
• Collaborate with lab staff to plan and manage laboratory samples, reviewing the laboratory manual.
• Report Serious Adverse Events (SAEs) to the Principal Investigator, Sponsor, and IRB within 24 hours, collecting required information.
• Maintain accurate visit logs and Clinical Trial Management System (CTMS) visit status.
• Facilitate ongoing Quality Assurance (QA) reviews, collaborating with the QA department on risk assessments, root cause analysis, and corrective/preventative actions.

Required Skills/Abilities:

• Exceptional verbal and written communication skills.
• Outstanding interpersonal and customer service skills.
• Strong organizational skills with keen attention to detail.
• Effective time management with a proven ability to meet deadlines.
• Analytical and problem-solving capabilities.
• Prioritization skills and ability to delegate tasks appropriately.
• Comfort in a high-paced environment.

Education and Experience:

• BSN, RN
• Preferably, at least two years of experience in a clinical research setting.
• CCRC certification is preferred.

Physical Requirements:

• Ability to lift up to 15 pounds.
• COVID-19 vaccination is required.

Additional Details:

• Location: Buffalo, NY (14217)
• Pay: $66K-$75K Annual Salary (Dependent on years of experience)
• Hours: Monday - Friday; 7:30AM-4:30PM (Onsite 5 Days a Week)
• Duration: 6 month Contract to Hire (1,040 hours) - contracted probationary period into direct hire / permanent position