Clinical Review/ Safety Reporting Specialist

Overview

This position 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

Able to complete the following job responsibilities under guidance of supervisor/ mentor, working toward limited supervision:

 

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; and

Apply MedDRA 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);Minimum of 5 years nursing experience required;

Minimum of 2 years Clinical research experieince preferred;

Demonstrated clinical knowledge to accurately assess and interpret clinical data;

Critical care nursing experience (IR, PACU, ICU) 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; andQualified 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.