Clinical Safety Specialist Job

Clinical Safety Specialist

Requisition 80792
Category Clinical Studies
Business Corporate-US Headquarters
Division Corporate Clinical
Location USA-CA-Santa Rosa
Relocation Relocation eligibility to be determined
Job Type Full Time - Regular
Exempt/Non-Exempt Exempt
Shift First
Travel Percentage 10 - 20%
Experience Required 2 years
Education Required Bachelors Degree

Medtronic is an Equal Opportunity/Affirmative Action Employer


Position Description

The Clinical Safety Specialist will work with other members of the MCRI Clinical Safety team located around the world, Clinical Operations, Data Management, Quality Assurance and Regulatory Affairs to manage death and adverse event reporting in compliance with applicable regulatory standards and Medtronic internal requirements.

Position Responsibilities

•Review and triaging clinical trial deaths and adverse events (AEs) including serious adverse events (SAEs).
•Conduct Case Management in the Clinical Safety Database.
•Interacts with investigational sites and field monitors to obtain additional pertinent information as indicated.
•Works with the clinical project team to ensure consistency in the assessment, recording and coding of clinical safety events (e.g., SAEs , adverse events (AEs), and device deficiencies). .
•Works with Regulatory Affairs, Clinical Operations and Field Assurance to ensure timely reporting of AEs, SAEs and UADEs including expedited and annual reporting and other documents as needed.
•Ensures appropriate distribution and notification of SAEs and UADEs to appropriate personnel, partners, and clinical centers for protocol(s).
•Liaison for safety-related questions ( e.g., to study team, field support, monitors, and study sites)
•Write Clinical Safety plan for assigned protocol(s).
•Assists with preparation of assigned section of safety reports for annual reports, clinical study reports, investigator brochure updates, and other documents as required.
•Collaborates with data management and other departments on the development of case report forms, study specific safety reports, and other study specific forms.
•Assists with the writing of safety sections of clinical protocols and may present safety monitoring at investigator meetings.
•Performs other duties as assigned.

Basic Qualifications

Thorough understanding of the general clinical research process with broad knowledge of GCP reporting guidelines, regulatory agency (US and OUS as is appropriate) regulations and varied medical conditions especially in the area of cardiology and vascular devices.

Minimum of 2 years in Safety, or 2 years in Clinical Safety and 2 years of Clinical Experience.

EDUCATION REQUIRED:
•Bachelor’s degree

YEARS OF EXPERIENCE
•A bachelor’s degree with minimum of 2 years safety experience or
•Master’s degree with 1 year Safety experience.

SPECIALIZED KNOWLEDGE REQUIRED

- Basic knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines
for clinical trials.

Desired/Preferred Qualifications

- MD, DO, RN, PA, PharmD, RPh, PhD or allied health professional including Biomedical Engineer, Biomedical Scientist, Paramedic with minimum of 2 years in Safety, or 2 years in Clinical Safety and 2 years of Clinical Experience or other equivalent background.
- Thorough understanding of the general clinical research process with broad knowledge of GCP reporting guidelines, regulatory agency (US and OUS as is appropriate) regulations
- Good written, oral, and interpersonal communication skills including knowledge of medical terminology.
- Proficient with MS Office products, word processing, spreadsheets, etc.
- High attention to detail and accuracy and ability to manage multiple tasks.
- Good prioritization and organizational skills.
- Excellent problem solving skills
- Flexible and dependable.
- Works effectively on cross-functional

Physical Job Requirements

The physical demands described within the Responsibilities 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

While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.
- Travel around 10%, at times may be as high as 30%, but very rare.

Nearest Major Market: Santa Rosa
Nearest Secondary Market: Petaluma
Job Segments: Biomedical Engineering, Clinic, Clinical Research, Compliance, Data, Data Management, Database, Engineering, Field Service, Healthcare, Law, Legal, Manufacturing, Medical Device, Medical Research, Medical Technology, Paramedic, QA, Quality, Quality Assurance, Regulatory Affairs, Research, Research Scientist, Safety, Science, Service, Technology, Vascular