Clinical Safety Coordinator - Remote US
About The Position
It’s More Than a Career, It’s a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day. Our Mission People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world. Our Safety Coordinator acts as the primary Pharmacovigilance (PV) (safety) representative and contact for investigational sites, and SCRI project teams for Investigator Initiated Trials (IITs) and Research Collaboration Trials. This is a fully remote position in the US; relocation assistance and visa sponsorship are not available. The work schedule for this position will be Wednesday - Sunday, traditional first shift hours.
Requirements
- Bachelor's Degree preferred, experience may be substituted for education
- Work experience with all Microsoft Office products including Excel, and varying software applications or databases
- 3+ years Data Entry experience in a hospital, medical office, or research environment requiring a high-level of attention to detail preferred
- Experience and ability to appropriately manage and prioritize assigned tasks and adhere to specific deadlines
Responsibilities
- Accountable for delivery of a Safety Monitoring Plan (SMP) for assigned trials, describing the end-to-end process for safety reporting, compliant with study protocol, Funding Partner requirements, and applicable PV regulations
- Prepares expedited individual safety reports and is responsible for ensuring further submissions via regulatory function e.g. FDA and site EC/IRB
- Proficient in safety case report data entry into the ARGUS safety database
- Reviews safety case reports to ensure ARGUS safety database entry is complete and accurate
- Other duties as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
