Associate Safety Review Specialist
Bring your Passion to Premier!
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in Rare Disease and Pediatrics, Analgesia, Neuroscience, Oncology, Dermatology, and Medical Devices.
We're looking for a talented and energetic Associate Safety Review Specialist to join our team!
Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact in an aspiring, empowering and caring culture where people truly work as one team. You can grow and contribute your expertise with colleagues who are genuinely supportive regardless of location or seniority. Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
What you'll be doing:
- Reviews CRFs, data listings, and database to ensure that captured data follow the rules outlined by the protocol and departmental plans
- Completes review of and performs quality control on adverse events, medications, physical examination, other exams, labs, and medical history data and other data as defined in the departmental plan for each study
- Generates queries to appropriate internal or external personnel (e.g., investigational sites, Clinical Research Associates and client representatives) to resolve problematic data identified during various aspects of the safety review process
- Reviews responses to queries for appropriateness and resolves any discrepancies
- Reviews CRFs and edit check specifications for potential data collection and representation, database structure or data entry problems, and provides feedback to the project team, when requested
- Performs Serious Adverse Event (SAE) reconciliation and manages the associated internal QC process for studies, as needed
- Maintains reconciliation spreadsheets (including the documentation of acceptable discrepancies
- Communicates any identified protocol violations to the data coordinator and/or clinical team
- Communicates any query trends in inaccurate/problematic data to the data coordinator
You'll need this background to be considered:
- Bachelor’s Degree or above (preferably in a Life Science)
- Typically requires 0 -1 year industry experience