Clinical Research Nurse Specialist

Posting Date 4 weeks ago(5/19/2021 9:08 AM)
Requisition ID
2021-9016
Job Location(s)
West Lafayette IN United States
Position Type
Full Time
Company
Cook Research Inc.
Category
Clinical

Overview

The Clinical Research Nurse Specialist at Cook Research Incorporated is responsible for reviewing data received in global clinical studies, for the purpose of ensuring consistent and accurate data, identifying significant events, and reporting in accordance with regulatory and study requirements.

 

 

Responsibilities

• Review all data for consistent and accurate reporting, adverse events, and product performance, and issue queries as needed
• Ensure that data review and adverse event reporting activities comply with quality system procedures, applicable standards, and clinical systems
• Develop and implement the event management plan
• Follow established procedures for TrackWise complaint database entry, investigation, and closure
• Develop and maintain a working knowledge of local and global regulatory requirements and standards (e.g., FDA CFR, ISO 14155, ICH GCP, EU MDR) that impact clinical studies, especially adverse event reporting
• Review and provide input for clinical study-related documents (e.g., CIP, CRF Specifications, Progress Report)
• Work closely with the clinical study team and Regulatory to ensure that data are consistently and accurately recorded to meet study needs
• Prepare clinical summaries for event reporting and regulatory submissions
• Coordinate study-related needs with the CEC
• Provide support for DSMB in collaboration with Clinical Scientists, including, but not limited to, study notifications, patient summaries, and attendance at meetings when needed
• Apply MedDRA and WHODrug coding to applicable studies
 

Qualifications

• Graduate of an accredited school of nursing required
• Bachelor of Science in Nursing (BSN) degree required (or equivalent in local region)
• Current RN licensure in the State of Indiana required (or equivalent in local region)
• Demonstrated clinical knowledge to accurately assess and interpret clinical data
• Experience in a variety of clinical settings preferred
• Conscientious, dependable, self-motivated individual with outstanding work ethic
• Strong problem-solving skills and personal discipline
• Excellent written and verbal communication skills
• Excellent organizational and prioritizing capabilities
• Ability to work both independently and within a dynamic team environment
• Qualified candidates must be legally authorized to be employed in the United States.  Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
 

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