Job Description

Responsibilities:

• Present clinical trial concepts, study objectives, and treatment details to potential participants for cellular therapy trials; conduct comprehensive screening and assessments to determine eligibility.
• Participate in the informed consent process and enroll eligible patients in accordance with study protocols.
• Collect, maintain, and organize regulatory documentation in compliance with Standard Operating Procedures and applicable regulatory requirements.
• Coordinate and support monitoring and audit visits, serving as a point of contact for onsite monitors and auditors.
• Coordinate patient care activities to ensure adherence to protocol-specific requirements.
• Collaborate closely with physicians to monitor patients for changes in clinical status, adverse events, concomitant medications, protocol compliance, and treatment response, ensuring thorough and accurate documentation.
• Work directly with research sites, sponsors, and other study stakeholders to support trial operations.
• Oversee the preparation of physician orders to ensure ongoing protocol compliance.
• Communicate with physicians regarding study requirements, dose modifications, and adverse event reporting.

Required Qualifications:

• At least two (2) years of experience in a clinical research setting
• Proficiency in essential clinical skills, including phlebotomy and obtaining vital signs

Preferred Qualifications:

• Graduate of an accredited nursing program (BSN preferred)
• Minimum of one (1) year of nursing experience
• Current Registered Nurse (RN) licensure in the state of Virginia preferred

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