Clinical Research Specialist - Structural Heart

at  Medtronic

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

NICE TO HAVE (PREFERRED QUALIFICATIONS):

• Degree in life sciences, or related medical/scientific field.
• Experience conducting/working on clinical studies and managing clinical trial data review
• Clinical Research experience at Medtronic or within a medical device industry, preferably in cardiovascular area
• CCRA certification (Certified Clinical Research Association) or SOCRA.
• Strong knowledge of clinical monitoring functions and clinical research methodologies, including study design, implementation, and reporting.
• Experience with Clinical Operations and interfacing with CRO teams.
• Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials.
• Excellent project management and organization skills.

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 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. For Office Roles: 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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

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 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. For Office Roles: 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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

TO BE CONSIDERED FOR THIS ROLE, THE MINIMUM REQUIREMENTS MUST BE EVIDENT ON YOUR RESUME.

• Bachelor’s degree
• Minimum of 2 years of clinical research experience OR
• Advanced degree with 0 years of clinical research experience

Responsibilities may include the following and other duties may be assigned.

• Reviews and approves required documents for study start, assures continued validity of such documents, takes actions for updates and/or replacements, and monitors site activation
• Performs site initiation activities, resolution and follow-up of site issues, and study closure activities.
• Provides support and training for clinical study sites to assure data integrity and protocol compliance. Prepares study materials and/or training and tracks and maintains study documentation. Prepares clinical case summaries. Sets up and maintains accurate clinical study files.
• Coordinates activities of associates (assigned clinical staff) and investigators to ensure compliance with CIP and overall clinical objectives
• Perform site file reviews
• Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), Good Clinical Practice (GCP) and specific country regulations and may prepare clinical trial budgets.
• Participates in overall clinical management plan, protocol and case report form development.
• Performs data review, reviews data discrepancies, ensures data queries are being resolved, works closely with monitors to ensure monitoring action items are resolved, and generates reports.
• Reports on progress and results of clinical investigations
• May be responsible for clinical supply operations, site and vendor selection.
• Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
• Assists clinical management with other duties as requested