Job Description

The ideal candidate for this position is a RN who is ready to forego shift work and move into a role primarily working regular Monday – Friday business hours. This position will combine the specialized RN knowledge with the responsibilities of a Clinical Research Coordinator to create a dynamic opportunity.

RN is a specialized professional working with and under the direction of the Director of Operations. In performing duties, the RN works with the Principal Investigator, staff, sponsor, and institution to support and provide guidance on the administration of compliance, financial, personnel and other related aspects of the clinical study. This multi-faceted role also includes fulfilling the responsibilities of a Clinical Research Coordinator.

The RN reports primarily to the Director of Operations with associated responsibilities to the Principal Investigator.

JOB DUTIES

Essential Duties

• IV Therapy
• Perform infusion of drug designated for clinical study, as directed
• Explain study protocols, procedures and treatments to patients and families
• Conduct the Informed Consent process in conjunction with study investigators
• Prepare laboratory specimens for analysis, monitoring tests and procedures, ship frozen specimen
• Ensure that all protocol activities are performed by approved research staff and ensure protocol compliance
• Acquire continuing education pertinent to research and their licensed profession
• Maintain complete regulatory files to include documentation
• Assist in assessing feasibility of clinical trials
• Assist in the preparation for pre-study visits
• Attend Investigator meetings and other relevant sessions
• Participate in site initiation meeting
• Help assure compliance with all relevant regulatory agencies
• On site study preparation
• Assist with site monitors for studies
• Assist with patient screening and recruitment
• Coordinate blood collection and shipment
• Maintain source documents
• Ensure site quality through compliance with standard operating procedures
• All other assigned duties

Marginal Job Duties

• Responsible for the handling, packaging, and shipping of biohazard goods under supervision and in compliance with State and Federal regulations
• Participate in the writing of protocols to ensure institutional compliance
• Help ensure compliance with all relevant regulatory agencies
• Oversee study data integrity
• Implement and maintain quality control procedures
• Prepare research reports for senior leadership
• Participate in any internal and external audits or reviews of study protocols
• Manage and ensure completion of study activities per protocol
• Collaborate with all staff and Principal Investigator (PI)
• Assist the Director of Operations in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan
• Maintain documentation of training
• Assist Principal Investigator to assure that all key personnel or persons ‘engaged’ in the research project have met training requirements in accordance with federal regulations and sponsoring agency policies and procedures
• Assist the Principal Investigator in submission of accurate and timely closeout documents to applicable federal agencies, or the sponsoring agency in accordance with federal regulations or sponsoring agency policies and procedures
• Arrange secure storage of study documents that will be maintained according to sponsor policy or for the contracted length of time, whichever is longer

Required for all Jobs

• Perform other duties as assigned
• Comply with all policies, standards, mandatory training, and requirements of BVL Research

QUALIFICATIONS

Education

• High school diploma or equivalent
• Bachelor or Associate Degree in Education, Nursing, Communication, Science, Health, Health Sciences, Human Relations, Healthcare, Medical

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