Medical Research Specialist

Medical Research Specialist

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.
•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 safety group meetings and monthly report
•Independently writes narratives and assembles dossier(s) for submission to Medical Director 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
•Collaborate with other staff to resolve complex or unclear situations
•Support Safety Project Manager or Project Team by serving as the MRA Lead
•Propose departmental continuous improvement initiatives
•Take lead role in training staff

Working Conditions:
•General office environment, minimal travel to hospital setting and/or professional meetings. Potential exposure to blood borne pathogens and other potentially infectious materials

Competency Expectations:
•Must be able to think analytically, have the ability to process scientific and medical data, with the ability to multi-task and problem solve.
•Must be able to work and make independent decisions, understand complex medical information, and be able to take the initiative to lead projects and assignments.
•Excellent organizational, project and time management skills.
•To be successful in this position it is important to have excellent working knowledge of regulatory guidelines (FDA/CFR; EN540/GCP), and medical terminology.

Qualifications/Work Experience

• The ideal candidate will have 5-7 years of experience in clinical research, neurovascular knowledge preferred.
• Experience in clinical trials and adverse event reporting is required.
• Must have strong computer skills.
• Experience with EDC and safety databases is preferred

Education and/or Special Training

•Bachelor's level degree or equivalent in health/science related field.