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.
DUTIES MAY INCLUDE BUT ARE NOT LIMITED TO:
• 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.
• 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