Research Nurse

• The Research Nurse will be involved in assigned clinical trials and is involved with the start-up phase through to the completion phase of the clinical trial.
• Will be involved in regulatory application, protocol implementation, compliance, recruitment, retention, and final termination of the trial.
• As such, will collaborate in development, preparation, and maintenance of regulatory documents; collaborate in determination of roles and responsibilities of study team members in the implementation of assigned clinical trials.
• Collaborate in the development of study tools including data collection forms, eligibility checklists, pre-printed orders.
• Assist in the management of clinical trial operations in compliance with institutional and federal regulations.
• Represent study team at study initiation meetings.
• Assist with organizing case report forms and regulatory binders.
• Screen potential research subjects for participation in clinical trials; evaluate ongoing eligibility of research subjects' participation in clinical trials.
• Demonstrate an understanding of the informed consent process.
• Obtain informed consent from research subjects when the protocol permits and document obtaining of informed consent in the medical record.
• In conjunction with PI and study coordinator, monitor protocol enrollment goals and collaborate in the development of recruitment strategies to ensure accrual and retention within goal time frames; demonstrate knowledge of protocol endpoint definitions.
• Assist with ensuring collection of pertinent data from internal and external sources.
• Monitor compliance with requirements of assigned clinical trials.
• Obtain and ensure proper distribution of required pharmacokinetic & tissue samples.
• Schedule, perform, and/or monitor procedures and tests per protocol requirements.
• Ensures and coordinate correct documentation of clinical study in medical record and appropriate protocol documents.
• Schedule visits, tests and procedures for patients entered in clinical trials per the protocol.
• As appropriate, ensure all required signatures are obtained on informed consent documents and validity of available informed consent documents.
• Perform subject interviews and assessments at study visits for data collection required by protocol, as appropriate.
• Apply pharmacologic knowledge to assist PI in determining adverse event causality and relationship to study drug/procedure.
• As appropriate, performs phlebotomy per policy and procedures; and documents per institutional standards.
• Make frequent (-monthly) participant visits and coordination as well as, blood draws in addition to clinical assessments.
• The Research Nurse must have the ability to demonstrate knowledge and skills necessary to provide care appropriate to the age of patients served.
• Able to prioritize workload and manage multiple projects effectively.
• Must achieve and maintain a working knowledge of computer software specific to department, including Microsoft Word and Excel, e-mail and internet functions and is knowledgeable of the Johns Hopkins Institutional Review Board and departmental Standard Operating Procedures.

• Must be a registered nurse, licensed in the State of Maryland or state where practicing required.
• Current Maryland State RN licensure required.
• Completion of JHH credentialing process and verification of CPR process required prior to start date.
• Must maintain current licensure and certification during duration of employment.

Preferred Qualifications:

• Bachelor's degree in nursing or related discipline preferred.