Sr Clinical Research Associate/ Drug Safety Associate
Our Client in Fremont, CA has the following Opportuntiy. Interested candidates, kindly respond to this job positing.
Receipt of initial reports and communication with clinical sites and external vendors to obtain required information for safety reporting
Tracking documents received, organizing/coordinating medical review of safety narratives and submission of final dossiers to CEC and/or central files
Maintenance of the safety database; compile event metrics for clinical team meetings and monthly report
Independently writes narratives and assembles dossier(s) for the purpose of regulatory reporting and CEC adjudication
Track CEC adjudication workflow
Generate safety queries to resolve data issues and apply corrections to database, working with the clinical research associate
Perform reconciliation of adverse events with SAE database according to established guidelines.
Generate reports from EDC systems , assess data for complaint reporting, and compile complaint notification forms
Search and summarize literature
Collaborate with other staff to resolve complex or unclear situations
Propose departmental continuous improvement initiatives
Take lead role in training staff
oBachelor's level degree or equivalent in health/science related field.
oThe ideal candidate will have 5-7 years of experience in clinical research, neurovascular knowledge preferred.
oExperience in clinical trials and adverse event reporting is required.
oMust have strong computer skills.
oExperience with EDC and safety databases is preferred
Under limited supervision of the Safety Manager(s), assume responsibility for the management of serious adverse event (SAE) and major adverse event (MAE) reporting for investigational and marketed devices. Works with confidential patient and company data. Internally interfaces with project team and field clinical monitors.
Estimated Salary: $20 to $28 per hour based on qualifications.
Receipt of initial reports and communication with clinical sites and external vendors to obtain required information for safety reporting
Tracking documents received, organizing/coordinating medical review of safety narratives and submission of final dossiers to CEC and/or central files
Maintenance of the safety database; compile event metrics for clinical team meetings and monthly report
Independently writes narratives and assembles dossier(s) for the purpose of regulatory reporting and CEC adjudication
Track CEC adjudication workflow
Generate safety queries to resolve data issues and apply corrections to database, working with the clinical research associate
Perform reconciliation of adverse events with SAE database according to established guidelines.
Generate reports from EDC systems , assess data for complaint reporting, and compile complaint notification forms
Search and summarize literature
Collaborate with other staff to resolve complex or unclear situations
Propose departmental continuous improvement initiatives
Take lead role in training staff
oBachelor's level degree or equivalent in health/science related field.
oThe ideal candidate will have 5-7 years of experience in clinical research, neurovascular knowledge preferred.
oExperience in clinical trials and adverse event reporting is required.
oMust have strong computer skills.
oExperience with EDC and safety databases is preferred
Under limited supervision of the Safety Manager(s), assume responsibility for the management of serious adverse event (SAE) and major adverse event (MAE) reporting for investigational and marketed devices. Works with confidential patient and company data. Internally interfaces with project team and field clinical monitors.
Estimated Salary: $20 to $28 per hour based on qualifications.
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