Safety Specialist, Sarah Cannon Research Institute - Nashville, TN
Sarah Cannon Research Institute -Nashville - Nashville, TN

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GENERAL SUMMARY OF DUTIES – Provides daily administrative support for Serious Adverse Event case processing in SCRI Services Safety Department. Conducts all activities according to applicable company SOPs, GCPs, ICH regulations and guidelines.
• Administrative processing of incoming serious adverse event (SAE) reports.
o Monitor and manage Outlook mailbox for incoming SAE reports.
o Distribute copies of incoming SAE reports to other designated stakeholders (e.g., study sponsor, pharmaceutical funding partner, project manager).
o Provide acknowledgement of SAE report receipt to study site.
o Maintain and archive documentation of SAE case receipt and distribution.
o Adhere to designated timelines for SAE case distribution.
• Post SAE reports and associated case documents to the Safety Department’s electronic repository, following designated document naming conventions.
• Assist safety department staff with other administrative tasks, as needed.
• Maintain other administrative files associated with SAE case processing.
• Comply with all applicable SCRI SOPS and guidelines, Good Clinical Practice (GCP) and ICH regulations and guidelines.
• Attend designated meetings and report on actions.
KNOWLEDGE, SKILLS & ABILITIES - This position requires the following minimal requirements:
• Proficient in Microsoft Windows and Office software (including Word, Excel, and Outlook)
• Ability to learn new computer software if required.
• Ability to operate copiers, fax machines and scanners.
• Ability to appropriately manage and prioritize assigned tasks and adhere to specific deadlines.
• Ability to multi-task in fast paced environment.
• Excellent written and oral English skills.
• Strong interpersonal, communication, and organizational skills.
• Detail-oriented.
• Knowledge of scientific, medical, and regulatory terms preferred.
• Certificate Course or Associates degree in a health or science related field, or equivalent of education and experience desired.
• Previous experience working in a healthcare, research, or other science related field desired.
• Clinical trial support or pharmaceutical industry experience desired, drug safety experience in clinical research or other health care environment preferred.
• Or equivalent experience