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Clinical Research Specialist

SunnyvaleMedtronic



Careers that Change Lives:

As a Clinical Research Specialist, you will be a member of the Early Technologies GI Solutions Clinical Affairs team and responsible for performing activities essential to clinical trial planning and execution. You will manage clinical trial sites, adverse event oversight, and provide support with all aspects related to clinical trial execution. You will collaborate with clinical trial site coordinators and investigators as well as various Medtronic functions to ensure clinical trial subject safety, data integrity and timelines.

You can grow your career with us; we hope you'll consider joining our team!

A Day in the Life:

  • Provide study management at site level for regulated and/or post-market studies to ensure successful conduct of clinical programs in accordance with corporate policies, standard operating procedures and federal regulations

  • Assist with study management by preparing all legal templates, country approvals, insurance certificates, vendor and lab agreements, and any project management documents, and SOPs

  • Prepare for study start up activities, enrollment and close out

  • Conduct studies according to GCP, and track study metrics

  • Participate, plan, and help lead study training (e.g. investigator/coordinator meetings, site initiation visits, internal study team training)

  • Participate, plan, and help lead site audits, and site monitoring.

  • Review study case report forms (CRFs) completed by the investigative sites, and verify entries by validating accurate source documentation to support CRF entries

  • Contribute to the project team by mentoring new members, assisting in preparation of project communications and tools, and sharing ideas and suggestions with team members

  • Act as site liaison

    Must Haves:

  • Bachelor's degree

  • 3+ years of experience in medical device Clinical Research

    Strong understanding and experience with databases and systems such as CTMS, eTMF, RAD, OCRDC

  • Strong writing skills and experience writing clinical protocols, ICF and SOPs

  • Training and experience with Good Clinical Practice (GCP) and FDA Medical Device regulations

    Nice to Have:

  • Knowledge and expertise in searching medical literature and databases for clinical and technical information

  • Basic understanding of statistics and statistical methods

    ABOUT MEDTRONIC:

    Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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.

    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.

    EEO STATEMENT:

    It 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

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