GENERAL SUMMARY OF DUTIES –
Responsible for: Providing daily case processing for Serious Adverse Event and administrative support in SCRI Services Safety Department. Duties include SAE report receipt, preliminary review of SAE report, entry of data in SAE tracking database, ensure SAE submissions are in compliance with federal, local and company regulations. Conducts all activities according to applicable company SOPs, GCPs, ICH regulations and guidelines.
DUTIES MAY INCLUDE BUT ARE NOT LIMITED TO:
- Processing of incoming serious adverse event (SAE) reports
- Monitor and manage Outlook mailbox for incoming SAE reports.
- Provide copy of reviewed SAE report to pharmaceutical partner(s) in the required time frame as per SCRI Safety department SOPs and WPGs.
- Distribute copies of incoming SAE reports to designated stakeholders (e.g. study sponsor, other team members, project manager).
- Provide receipt of SAE report to study site.
- Maintain and archive documentation of SAE case receipt and distribution.
- Adhere to designated timelines for SAE case distribution.
- Enter SAE report data (initial and follow-up reports) into SAE tracking data base.
- Enter SAE report data (initial and follow-up reports) into ARGUS and document/ track generated case ID numbers.
- Draft clinical narrative for the SAE reports for further review.
- Submit any necessary SAE report queries (internally generated or from pharmaceutical partners) to study site and track for resolution.
- Monitor SAE notifications from TrialMaster (confirm if SAEs should be reported/amended).
- Post SAE reports and associated case documents to the Safety Department’s electronic repository, following designated document naming conventions.
- Provide guidance and overview to the Safety Specialist I and Safety Specialist II.
- Provide SAE reporting training for study site personnel.
- Perform timely quality checks in SAE tracking data base and Argus.
- File completed SAE reports in designated areas.
- Create files for new activating studies (e.g. fax cover sheets, Safety Department’s electronic repository)
- Work with other study team members, regulatory personnel, and study site staff to facilitate understanding and adherence to protocol requirements for SAE reporting.
- Attend designated meetings, conference calls, and monthly staff meetings as appropriate.
- Perform related work as required.
- Participate in educational activities and programs when available.
- Comply with all applicable SCRI SOPs and guidelines, Good Clinical Practice (GCP) and ICH regulations and guidelines.
- Maintain strictest confidentiality.
KNOWLEDGE, SKILLS & ABILITIES - This position requires the following minimal requirements:
- Ability to work within deadlines
- Proficiency in Microsoft Windows and Office software (including Word, Excel, and Outlook). ARGUS Database experience is also desirable.
- 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.
- Strong interpersonal, communication, decision making, and organizational skills.
- Knowledge of scientific, medical, and regulatory terminology is strongly desired.
- Certification Course or Associates degree in science related field or equivalent of education and experience required.
- Two years in a healthcare, research, or other science related field or equivalent of education and experience is required.
- Two years in Safety experience in clinical research or other health care environment is strongly preferred.
- Experience working with FDA clinical trial drug safety regulations and familiarity with drug safety reporting requirements preferred.
- Or equivalent experience
HCA Inc - 2 years ago