Sarah Cannon , the Cancer Institute of HCA Healthcare, offers integrated cancer services with convenient access to cutting-edge therapies for those facing cancer in communities across the United States and United Kingdom. Sarah Cannon's cancer programs include individualized patient navigation provided by oncology-trained nurses, more than 1,000 stem cell transplants performed annually throughout the Sarah Cannon Blood Cancer Network, hundreds of clinical trials, and molecular profiling capabilities. Through its services, Sarah Cannon is providing state-of-the-art cancer care close to home for hundreds of thousands of patients, a number unmatched by any single cancer center.
By bringing together a network of globally-recognized cancer experts, we are collaborating and sharing best practices that address every aspect of the cancer journey, from screening and diagnosis through treatment and survivorship.
Sarah Cannon Research Institute is the research arm of HCA Healthcare's global cancer institute, Sarah Cannon. Focused on advancing therapies for patients, it is one of the world's leading clinical research organizations conducting community-based clinical trials throughout the United States and United Kingdom. Sarah Cannon's network of strategic sites includes more than 275 physicians who engage in research. The organization has led more than 260 first-in-man clinical trials since its inception in 1993, and has been a clinical trial leader in the majority of approved cancer therapies over the last 10 years. Summary of Key Responsibilities:
Responsible for: Providing daily case processing for Serious Adverse Event and administrative support in Sarah Cannon Development Innovations Pharmacovigilance (PV) 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 and Responsibilities
Duties 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 Sarah Cannon Development Innovations Pharmacovigilance Department SOPs and WPGs
- Distribute copies of incoming SAE reports to designated stakeholders (e.g. study sponsor, other team members)
- 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
- Perform preliminary assessment for medical coherency of the SAE reports
- Draft clinical narrative for the SAE reports for further review and assessment by the Sponsor Medical Monitor
- Follow SAE reports until resolution of events
- Submit any necessary SAE report queries (internally generated or from pharmaceutical partners) to study site and track for resolution
- Post SAE reports and associated case documents to the Pharmacovigilance Safety Department's electronic repository, following designated document naming conventions
- Generate, review and distribute routine SAE Report (e.g., SAE line listings)
- Participate in Site Initiation Visits (SIV) to conduct SAE Reporting per protocol specifications
- Provide guidance and overview to the Safety Specialist/s
- Provide SAE reporting training for study site colleagues
- 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, Pharmacovigilance Safety Department's electronic repository)
- Work with other study team members, regulatory colleagues, 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 Sarah Cannon SOPs and guidelines, Good Clinical Practice (GCP) and ICH regulations and guidelines
- Maintain strictest confidentiality
: A body of information needed to perform tasks; May be obtained through education, training or experience
- Knowledge of scientific, medical, and regulatory terminology is strongly desired.
The proficiency to perform a certain task
- Skills in Microsoft Windows and Office software (including Word, Excel, and Outlook). ARGUS Database experience is also desirable.
- Able to operate copiers, fax machines and scanners.
An underlying, enduring trait useful for performing duties
Qualifications: Minimum Qualifications Education: Minimum Required:
- Ability to work within deadlines
- 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.
High School Diploma (GED) Preferred:
Associate's Degree (2 year program) Experience: Minimum Required:
- Two years in a healthcare, research, or other science related field or equivalent of education and experience
- A proactive attitude, work ethic and ability to be flexible in your daily responsibilities as they change from day to day
**If interested in advancing your career with a growing leader in cancer research please apply today!
- Two years in Safety experience in clinical research or other health care environment is strongly
- Experience working with FDA clinical trial drug safety regulations and familiarity with drug safety reporting requirements