Clinical Research Specialist

Medtronic
Posted

Post Expires

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Researcher / analyst

 The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.BRAIN THERAPIES offers an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.   A Day in the LifeThe Clinical Research Specialist supports the planning and conduct of clinical studies and ensures compliance to the study protocol, ICH-GCP guidelines, applicable regulatory standards, and Medtronic Standard Operating Procedures. The Clinical Research Specialist is responsible for site management activities such as collecting, reviewing, and tracking essential documents, reviewing the data, and ensuring site compliance. 

  • Contribute with protocol development including literature review, compilation of feedback from the cross functional team and key opinion leaders, and drafting essential documents
  • Contribute in the development and review of Clinical Investigational Plans with statistical justifications, patient informed consent, case report forms, clinical study material, and clinical databases in collaboration with cross functional teams
  • Interface with physicians and study support personnel
  • Contribute in the management of interaction between sites, vendors, and cross functional team members
  • Assist with investigator and site selection process
  • Participates in one or more clinical studies from preparation, activation, enrollment, submission, maintenance, and study closure phases
  • Contribute in the management of investigative sites from study start up through close out
  • Contribute to the development and maintenance of the study budget
  • Ensures appropriate oversight of clinical study by internal and external resources including, but not limited to monitoring, staff, CROs, and core laboratories
  • Responsible for Device Accountability and Reconciliation
  • Contribute in the preparation of clinical protocols and regulatory submissions including 510(k), PMA, IDE, and others
  • Contribute in the development and completion of regulatory reporting requirements, internal reporting requirements, and clinical publications and presentations
  • Review clinical monitoring reports
  • Contribute in the overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies; e.g., monitoring reports, device tracking, and CAPA tracking systems
  • Evaluates clinical and adverse event data for completeness during the conduct of the study and for completion of clinical study reports
  • Collaborate with monitor for closure of site action items, collection of source documents and regulatory items
  • Ensures quality by maintaining compliance, reviewing device complaints, reviewing audit reports, and implementing corrective actions
  • Participate in clinical site audit activities including pre-inspection training at clinical sites and within the department
  • Ensure general logistical support for meetings, such as document preparation and taking meeting minutes
  • Coordinate physician meetings such as Investigator Meetings, Clinical Events Committees, and Data Safety Monitoring Boards
  • Maintain CTMS and study trial master file and other project tracking tools
  • Ensures set up of Trial Master File (TMF) folder structures in document repositories and files all essential clinical study documentation in TMF for one or more studies per standard operating procedures and study plans
  • Performs related duties as assigned

Must Have: Minimum Qualifications

  • Bachelors degree required

 

  • At least 1 year of contributing to trials with medical device implants
  • Good working knowledge of MS Excel, PowerPoint, Word, and internet search engines
  • Working knowledge of the Code of Federal Regulations 21 CFR, ISO 14155, Medical Device Directive (EC), and Good Clinical Practices (GCP)
  • Proficient knowledge of medical terminology
  • Excellent written, oral, and interpersonal communication skills
  • Ability to work independently and effectively on cross-functional teams
  • Ability to comply with written procedures, instructions, SOPs and other documents
  • Results and solution oriented
  • Customer focused
  • Master’s or Advanced Degree preferred
  • Medical device experience preferred

Physical Job Requirements: Ability to travel at least 20%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.  About MedtronicTogether, 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.  EEOIt is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here:http://www.uscis.gov/e-verify/employees

More Information

Posted

Post Expires

Type

Researcher / analyst

Irvine%2C%20United%20States

Irvine , United States