Job Details

Job Title: Clinical Research Specialist
Job ID: 23855
Location: Remote
Duration: 24 Months
Payrate: $35.00- $38.00/HR. on W2

Job Decription:
HM's Top Needs:
Basic medical terminology and interpretation of clinical data - capable of reading and comprehending medical records and imaging reports (clinical, medical, nursing, or radiological background is welcome!).
Proficiency in Client Office (Excel, Word, PowerPoint) with a basic understanding or willingness to learn Systems & Technology (Safety Databases & Tools).
Fundamental knowledge of Clinical Research.

Education Required: equivalent to a bachelor's degree
Years' Experience Required: Minimum 1 year
Will the contractor be working 40 hours a week? If not, weekly estimate? Yes 40 hours
Work Location:
Do they need to be local to any MDT office and if so where? Flexible remote , Location at central time
Does this person need to be on site? If so, full time or part time? Not a requirement,

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 Client (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 Client 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 non-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 Client 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).