Not provided by employer
Maintaining high quality and accuracy in the identification and reporting of drug safety events is a critical function within corevitasAs a research assistant, drug safety you will support collection, tracking, document processing, safety data management, helping to coordinate assignments and related work group activitiesThis role provides critical support to multiple team members and company priorities.
Your responsibilities will include:
Tracking details for incoming adverse event reports
Tracking site follow-up action items for targeted adverse events (e.gMissing, incomplete taes)
Supporting follow-up activities with registry sites as assigned to support safety data management
Screening of received questionnaires for completeness, in accordance with internal guidance
Document processing support including creation of pdf backup files and uploads to central file
Creation of electronic backup files, adjudication packets for completely reported events
Data entry support for targeted adverse events and adjudication results, as needed
Data entry and consolidation to complete case migration for software implementations, as assigned
Preparing case adjudication packets for shipment to adjudication team(s), per specifications
Support of site qc cycles to promote timely resolution of open site action items
Organizing and scheduling team meetings, if needed
Ongoing professional training or education appropriate to role, as assigned
Participation in team meetings and conference calls, as assigned
Participation in assigned work groups or task forces for priority pv team work streams or initiatives
Other duties as assigned
Additional experience and qualifications
Bachelors in science (or relevant alternate concentration)
Highly detail-oriented with excellent time management skills
Strong written and verbal communication skills
Proficiency in ms office: word, powerpoint, excel, outlook
Completion of gcp training (provided by corrona)
Medical terminology (training support available)
Training and/or experience in a related discipline (e.gResearch, clinical training) preferred
For immediate consideration apply directly at www.corevitas.com.
Corevitas is the built-for-purpose gold-standard provider of real-world evidenceCorevitas provides a holistic approach to capturing real-world data through patient-centered solutions including clinical registries, patient insight studies, biospecimen solutions and specialty electronic health record (ehr) dataProviding curated data while leveraging a cloud-based secure technology platform enables the company to aggregate and process longitudinal data at scale and handle a broad spectrum of clinical and patient-reported outcomesLeveraging these data and analytic services, corevitas helps biopharmaceutical companies demonstrate the value of their products to clinicians, patients, payers, and regulators.
We operate eight major autoimmune and inflammatory registries across the us, canada, and japan, collecting data from nearly 500 clinical sitesIn addition to our registry operations, we consist of additional specialty teams: healthivibe, the patient experience unit, complements and strengthens our disease registries by providing market-leading expertise in supporting innovative, evidence-based patient engagement initiatives across the entire product lifecycleOur healthunlocked technology platform hosts over 1.4 million patients in hundreds of condition-specific communities and significantly enhances the depth and breadth of patient experiential dataThrough our health iq division, corevitas has access to a broad range of uk-based and international data sets enabling us to understand market access issues, including clinical utilization, capacity planning, and cost optimizationVestrum health, a leader in data analytics of retinal practice ehr, provides insightful views of retinal diseases across the drug life cycleCorevitas is an audax private equity portfolio company.
Corevitas is proud to provide equal employment opportunities to all qualified individuals without regard to race, color, religion, sex, gender identity, sexual orientation, pregnancy, age, national origin, physical or mental disability, military or veteran status, genetic information, or any other protected classificationMinorities, women, lgbtq candidates, veterans, and individuals with disabilities are encouraged to apply.