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Clinical Research Specialist

Mounds ViewMedtronic



POSITION DESCRIPTION

The Clinical Research Specialist will assist with study management duties for assigned clinical programs to evaluate performance, safety, and efficacy of products and to satisfy applicable regulatory standards and Medtronic internal requirements for regulated clinical studies (domestic and international).

POSITION RESPONSIBILITIES

  • Assists with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies.

  • Participates in overall clinical management plan, protocol and case report form development.

  • Evaluates clinical data and participates in clinical report generation.

  • Assists with resolution and follow-up of site issues.

  • Provides support and training for clinical study sites to assure data integrity and protocol compliance.

  • Assists in preparation of study materials and/or training.

  • Tracks and maintains study documentation.

  • Performs data review, generating queries and reports; generating data discrepancies and reviewing completed discrepancy documents.

  • May interface with representatives from key functional groups including Product Development, Manufacturing, Sales & Marketing, Distribution, and Regulatory Affairs.

  • Assists with study closure activities.

  • Assists with publication of study data in medical literature and/or presentation at scientific meetings.

  • Prepares clinical case summaries.

  • Sets up and maintains accurate clinical study files.

  • Provides support for development of marketing materials to support product activities.

  • Contributes to ongoing SOP review and development.

  • Assists clinical management with other duties as requested.

    IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME

    BASIC QUALIFICATIONS

    EDUCATION REQUIRED

  • Bachelor's degree

    YEARS OF EXPERIENCE

  • 2 + years experience in clinical research (GCPs and regulatory compliance guidelines for clinical trials).

    DESIRED/PREFERRED QUALIFICATIONS

  • Bachelor's degree in engineering, life sciences, or related medical/scientific field.

  • Ability to manage multiple clinical research sites with proven results in study execution.

  • Proficient knowledge of medical terminology

  • Knowledge of GCPs and regulatory and compliance guidelines for clinical trials

  • Computer experience with knowledge of word processing and applications such as Word, Excel and PowerPoint.

  • Demonstrated independent working skills.

  • Ability to work well in a dynamic, fast paced work environment

  • Ability to shift priorities and work plan based on department needs

  • Excellent written and verbal communication skill

  • Capable of working on multiple projects in a deadline driven environment - demonstrated skill under pressure

  • Accuracy and attention to detail essential

  • Ability to travel as needed

    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.

    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.

    Ability to travel up to 10-20%

    MEDTRONIC OVERVIEW:

    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 can 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.

    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

    The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

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