Medical Affairs Safety Clinical Research Specialist - Full-time / Part-time

Medical Affairs Safety Clinical Research Specialist

Careers that Change Lives

The Medical Affairs Safety Clinical Research Specialist is responsible for coordination of safety activities to assure compliance with regulations and Medtronic standards, guidelines and policies. Coordinate activities related to safety assessment, report management, safety committees, system and process development, policy review and implementation, and management review. Contribute to accurate and timely reports for study teams and management, including resolution of action items. Maintain documentation consistent with Medtronic standards, guidelines and policies. Execute continuous improvement projects, perform other duties and ad hoc projects as assigned in support of the Clinical Research department.

A Day In The Life

• Execute Safety Process in collaboration with Medical Affairs
• Study Material Management: coordinate the development and/or review of essential study material related to the safety process (protocols, CRFs, safety plans)
• Safety Data Management: coordinate the development, collection, analysis, trending, and tracking of study safety data (adverse events, complaints, deficiencies), coordinate medical coding activities
• Report Management: manage the development/update of safety reports, perform and/or coordinate review of study periodic reports ( CSR), follow-up on vigilance reporting
• Safety Liaison: collaborate with Study Managers, Monitors, Management on safety matters (training, interpretation, data entry, query resolution)
• Committee Management: coordinate committee activities (member identification, contracts, disclosures, meeting coordination, material preparation, action item coordination)
• System Management: coordinate development/update safety systems and processes (safety database, coding dictionaries, system assessment/integration/deployment)
• Policy Management: coordinate development/update of safety procedures, forms, templates, perform study impact assessments, coordinate deployment)
• Safety Operations Management: metric development, collection, analysis, trending, and tracking
• Coordinate support for study teams to ensure successful clinical safety execution consistent with applicable regulations, guidelines and policies. This may involve multiple regulatory requirements, based on location of study conduct
• Execute process improvement projects and ad hoc projects as assigned
• Attend and support clinical study meetings as applicable
• Support development/revision and implementation of procedures aligned with relevant global regulations and standards
• Determine obstacles, identify solutions, and implement plans in collaboration with management to meet study objectives, scope and schedules

Must Have; Minimum Requirements

• Bachelor's degree
• Minimum 2 years of work experience in clinical/clinical research setting in healthcare industry (i.e. medical device, biotech, pharmaceutical) or Master's degree and 1+ year of work experience in clinical / clinical research setting in healthcare industry (i.e. medical device, biotech, pharmaceutical)
• Knowledge of applicable regulations including Federal Code of Regulations
• Knowledge of clinical research design
• Experience interacting with healthcare professionals, business management, and patients

Nice to Have

• Experience in medical device clinical trials/clinical trial setting
• Experience in Project management and database systems (e.g., MS Project, Access, CTMS, SAP, Agile)
• Proficiency in word processing, spreadsheets applications (e.g., MS Word and Excel)
• Experience with Good Clinical Practice (GCP), regulatory and/or compliance guidelines for clinical trials
• Strong verbal and written communication skills, technical and problem solving skills
• Able to read, analyze and interpret general business documents, technical procedures, and specifications
• Able to work effectively, independently and on cross-functional teams
• Able to write reports, business correspondence and procedure manuals effectively
• Able to frequently use general knowledge of industry regulations, practices, techniques, and standards
• Develops solutions to a variety of problems of moderate scope and complexity

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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