Sr Clinical Research Specialist Job

Sr Clinical Research Specialist

Requisition 81192
Category Clinical Studies
Business Corporate-US Headquarters
Division Post Approval Network
Location USA-MN-Fridley
Relocation No relocation assistance
Job Type Full Time - Regular
Exempt/Non-Exempt Exempt
Shift First
Travel Percentage 10 - 20%
Experience Required 4 years
Education Required Bachelors Degree

Medtronic is an Equal Opportunity/Affirmative Action Employer


Position Description

Conducts clinical studies in compliance with applicable clinical and regulatory standards and in alignment with Medtronic business objectives. This role will be responsible for serving as the primary point of contact and subject matter expert for assigned centers. The role will interact with multiple stakeholders in order to proactively manage center performance and foster strong customer relationships.

Position Responsibilities

- Provides customer focused support to prevent or mitigate potential customer issues
- Responsible for review and oversight of data
- Works directly with center personnel to resolve data discrepancies and monitoring action items
- Proactively monitors overall center performance metrics, enrollments, and compliance
- Produces and distributes site communications
- Assist in the development of the Clinical Investigational Plan, Clinical Management Plan, Data Management Plan, study training materials, and study reports
- Trains on the study protocol
- Trains on the electronic data capture system and manages account set-up’s
- Manage center activation requirements
- Informed Consent review
- Consulting Committee Oversight
- Support Consultant written publications
- Write annual and final study reports

Basic Qualifications

EDUCATION REQUIRED:
Bachelor’s degree in clinical or scientific field

YEARS OF EXPERIENCE
Minimum of 4 years of clinical research experience working in an academic or corporate environment ( or 2 years of experience with Masters)

Desired/Preferred Qualifications

- Experience with Good Clinical Practices (GCP), SOP’s, or applicable regulations related to the conduct of clinical trials
- Professional clinical research certification (e.g., Association of Clinical Research Professionals, Society of Clinical Research Associates)
- Previous Device therapy experience
- Trial design knowledge to be able to create, implement and publish information that fills evidence gap
- Strong interpersonal and communication skills
- High Attention to detail
- Experience developing solutions for a variety of problems of varying scope & complexity
- Experience with translating analytics into executable business objectives or strategy
- Seeks out and applies continuous learning
- Builds relationships and networks with physicians, and cross functional partners
- Clinical/Science/Research Background
- Knowledge of medical terminology, clinical practices, disease states and relevant literature
- Proficient knowledge in word processing, spreadsheets, and/or database applications (e.g., MS word and Excel)

Physical Job Requirements

- 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.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ability to travel 15% of the time.

Nearest Major Market: Minneapolis
Job Segments: Clinic, Clinical Research, Compliance, Consulting, Data, Data Management, Database, Healthcare, Law, Legal, Medical Device, Medical Research, Medical Technology, Research, Technology