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Job Requirements of Assoc Clinical Safety Specialist:
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Employment Type:
Contractor
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Location:
Little Canada, MN (Onsite)
Do you meet the requirements for this job?
Assoc Clinical Safety Specialist
Assoc Clinical Safety Specialist
Location: Remote only in Minneapolis, MN or Santa Rosa, CA
Duration: 24 Months+
Shift: CST/PST Hours
Pay Range: $30-$39/hr on w2
HM's Top Needs:
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Science, nursing or medical background
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Experience with for example RAVE and VAULT database
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Safety experience is a nice to have
Education Required: Bachelor
Years Experience Required: 1-5 years as this is for an Associate position
Hours: 40 hours weekly is estimated
Work Location: Remote or close to MDT office Minneapolis, MN or Santa Rosa, CA
Does this person need to be on site? Not required if hired remote- Will work Remotely Only
Position Description:
The Clinical Safety Specialist is responsible for safety and potential complaint data throughout the clinical study to ensure compliance with respect to the reporting of clinical study safety and potential complaint data to meet regulatory requirements. The MCRS Clinical Safety Specialist will partner with various colleagues across Healthcare (e.g., other members of the MCRS Clinical Safety team, other MCRS functions, Regulatory Affairs, Clinical teams in the Operating Units) to manage adverse event, death, and device deficiency reporting in compliance with applicable regulatory standards and Healthcare internal requirements.
Position Responsibilities may include but not limited to:
Review and assess clinical study Adverse Events (AEs) including Serious Adverse Events (SAEs) and device deficiencies
Review n on-AE Case Report Forms to detect potential complaint and potential unreported AEs
Interact with investigational sites and clinical monitors to obtain additional pertinent information as indicated in the Clinical Investigation Plan (CIP)
Ensure consistency in the assessment of clinical safety events
Work with Regulatory Affairs and the Product Complaint Reporting teams to ensure timely reporting of AEs, SAEs, and Unanticipated Serious Adverse Device Effects (U[S]ADEs) and potential complaints
Ensure appropriate distribution and notification of SAEs and U[S]ADEs to appropriate personnel, partners, and investigational sites per CIP
Act as liaison for safety-related questions (e.g., to study team, field support, monitors, and study sites)
Author Clinical Safety Management and Potential Complaint Plan (CSMPCP) for assigned studies
Assist with preparation of assigned section of safety reports for annual reports, clinical study reports, and other documents as required
Collaborate with Data Management and other departments on the development of case report forms, study specific safety reports, and other study specific forms
Assist with the writing of safety sections of CIPs and may present Clinical Safety requirements at investigator meetings
Support study audit for Safety-specific topics
Facilitate Clinical Event Committee (CEC) work (author CEC charter, review source documents, ensure all CEC events are adjudicated by CEC)
Support database snapshot activities (e.g., meet with study team, review timelines, perform reconciliation and data cleaning activities to be audit & snapshot ready)
Prepare, attend and/or lead Safety Trending meetings
Perform other Clinical Safety tasks as assigned
Training Requirement:
This MCRS Clinical Safety Specialist position is linked to the Healthcare Job Family Clinical Research, more specifically the specialist career stream including the following job codes referring to different levels of maturity: 140720, 140730, 140830, 140850 and 140860. Refer to these Job Descriptions for the position requirements (e.g., Required Knowledge and Experience, Differentiating factors).