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