14 Aug
Clinical Study Nurse (Registered Nurse/LPN/Licensed practical nurse)
Vacancy expired!
Job Description
Clinical Study NurseDuration: 2 + monthsClient location: Indianapolis IN 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
- 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
- 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.
Vacancy expired!