Clinical Research Coordinator
1 hour ago
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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