Careers that Change Lives
We are excited to be hiring a Clinical Studies Project Coordinator V to join the Medtronic Post Approval Clinical Surveillance Organization Operating Unit. In this role, you will be providing support to the Product Surveillance Registry teams and studies. The Clinical Studies Support Coordinator V will independently perform diverse administrative and project duties within a high functioning and dynamic team environment. This is a remote based role so the candidate can live anywhere in the US.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
Supports clinical studies by executing and maintaining one or more of the following areas.
Data coordination- actively participates in the development and testing of case report forms, study reports, and study databases based on protocol requirements.
Ensures timely and quality completion of data forms, verifies study data, and generates, manages, and resolves data discrepancies.
Support assignment for study specific training and rosters
Document coordination - creates and manages the clinical study files and oversees the organization and distribution of clinical study documents.
Assists with periodic audits of clinical study files for completeness and accuracy.
Provide project/program coordination and support to Global Clinical Study team
Maintains study-specific correspondence and other required documentation
Assists/coordinates in the organization and distribution of clinical study documentation
May assist in tracking study activity, such as start-up progress by ensuring receipt of proper study documentation, agreements, and site approvals
Assist in the coordination of meetings and meeting logistics
Attends team meetings, taking notes on discussion points and action items-ensuring proper follow through
May work with clinical teams to create and distribute newsletters and communications to sites
Support, monitor, and analyze daily projects and contracts using Excel, Power Point, SCTMS, RAD, Vision Tracker, SharePoint, and shared network drive
Create, run, and monitor metrics and maintenance reports on an ongoing basis
Identifies issues in documents, memos, correspondences, and telephone calls which require action. Recommends alternatives and executes an alternative when appropriate
Support process improvements efforts to enhance systems and reduce lead time
Perform various study duties including facilities coordination, project document organization and reconciliation, setting up files, ordering supplies/equipment, photocopying
Solves problems of moderate scope and complexity following established policies and procedures
Works under general supervision
Other duties as assigned
Must Have: Minimum Requirements
High School Diploma or GED with 10+ years of administrative or project support experience
Nice to Have
Associate's or bachelor's degree preferred
5+ years of work experience as a project coordinator/administrative assistant
Clinical research/study coordination experience at Medtronic or medical device industry
Experience with medical devices products/therapies
Experience working with Siebel CTMS and Clinical RAD applications
Knowledge of medical terminology
Basic knowledge of GCP and regulatory compliance guidelines for clinical trials
Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications.
Competencies:
Excellent customer service orientation
High attention to detail and accuracy
Demonstrated independent working skills
Experience working in a highly-matrix, dynamic, and fast-paced work environment (ability to shift priorities & work plan based on department needs)
Excellent written and verbal communication, and interpersonal skills
Capable of working on multiple projects in a deadline driven environment - demonstrated skill under pressure
Strong prioritization and organizational skills
Positive outlook, flexible and dependable
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 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)
