Clinical Study Nurse (Registered Nurse/LPN/Licensed practical nurse)
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Job Description
Clinical Study Nurse Duration: 2 + months Client location:Lexington, KY
Purpose: Support study sites in the coordination of Phase I-IV clinical research studies, ensuring that studies are carried out according to protocol, standard operating procedures, GCP, and other applicable guidelines and regulations.
Responsibilities:
Coordinate clinical research studies conducted by a supervising principle investigator
Update and maintain skills, training and knowledge of current best nursing practice and topics related to clinical research
Safeguard the well-being of the subjects and ensure and maintain high standards
Maintain a safe environment in accordance with the Health and Safety policies
Act as volunteer advocate
Deal with volunteer and visitor concerns in a pro-active manner and taking remedial action as required
Assist staff, both registered and unregistered in Nursing Practices and the delivery of care to the volunteer
Report any deviation from normal practice to senior staff
Support study conduct by review of the study protocol, case report form (CRF), other study documents, and electronic data capture systems
Participate in project meetings with the project team as needed
Perform clinical set-up and preparation for the study including labeling specimen collection tubes and containers, setting up equipment and documents
Plan logistical activity for procedures as per protocol
Generate volunteer instructions
Identify and obtain required supplies and equipment
Prepare and deliver study specific training materials, documents, and records
Troubleshoot study issues
Participate in huddles to ensure daily tasks are assigned to team members are executed to the expected standards
Assist with data quality checking and query resolution to ensure that data collected on study volunteers adhere to study protocol and ensuring quality control for content accuracy and completeness
Recruit and Screen volunteers for inclusion in study based on pre-determined criteria
Orientate volunteers to the study and the site including the purpose of the study, procedures and practical issues such as timelines for visits
Responsible for the correct administration and custody of study drug according to site standard operating procedures
Perform a variety of complex clinical procedures on subjects including but not limited to ECG, sample collection including phlebotomy, spirometry, vital signs, cannulation, and cardiac telemetry monitoring
Collect, record, and report clinical data and findings appropriately in case report forms (CRFs)
Collaborate closely with study investigator informing on relevant adverse events and serious adverse events according to procedures outlined in the protocol
Cooperate with study monitor and reserve sufficient time for questions during monitoring
Qualifications
Required Knowledge, Skills and Abilities
Good knowledge of clinical trials
In-depth knowledge of the principles of Good Clinical Practices (GCP)
Good skill in using MS Windows and Office applications
Effective written and verbal communication skills including good command of the English language
Excellent interpersonal skills
Excellent problem-solving skills
Effective organizational skills
Ability to pay close attention to detail
Ability to establish and maintain effective working relationships with coworkers, managers and clients
Minimum Required Education and Experience:
Bachelor's degree or educational equivalent in Nursing and 1 year relevant experience; or equivalent combination of education, training and experience
Current active nursing license in the state, country, or region in which the site resides
Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies
Physical Requirement:
Use of telephone and face-to-face communication requiring accurate perception of speech
Use of keyboard requiring repetitive motion of fingers
Frequent mobilization around the facility
Additional Information
All your information will be kept confidential according to EEO guidelines.