14 Aug
Clinical Study Nurse (Registered Nurse/LPN/Licensed practical nurse)
Indiana, Usin 00000 Usin USA

Vacancy expired!

Job Description

Clinical Study Nurse

Duration: 2 + months

Client 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

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.

Vacancy expired!


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