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Associate Clinical Research Specialist - Aortic And Peripheral Vascular

Expired Job

Medtronic Inc. Santa Rosa , CA 95402

Posted 4 months ago

Associate Clinical Research Specialist - Aortic and Peripheral Vascular Group

Careers that change lives

The Associate Clinical Research Specialist is responsible for helping to design and execute clinical studies across the Aortic portfolio with the intent to evaluate the safety and effectiveness of a new product. As part of this, the candidate is accountable for several key components of clinical trial execution, which may include site management responsibilities, safety reporting, vendor oversight, and report writing. This person will work collaboratively with other key stakeholders to generate high quality clinical evidence, ensure successful and timely completion of studies, and coordinate activities with clinical affiliates in worldwide studies in conformance with applicable federal regulatory requirements. We are looking for a candidate with growth potential, strong clinical trial execution expertise, a proven track record of meeting aggressive timelines, and the ability to partner cross-functionally.

Position Responsibilities:

  • Designs, plans and develops clinical evaluation research studies.

  • Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.

  • Oversees and interprets results of clinical investigations

  • 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.

  • May be responsible for clinical supply operations, site and vendor selection.

  • Contribute to CIP (Clinical Investigational Plan) ICF (Informed Consent Form), eCRF (Case Report Form), and CSR (Clinical Study Report) development, and APR (Annual Progress Report)

  • Meet Global Regulatory Reporting Requirements

  • Site Management responsibilities, which may include activating sites, tracking enrollments, and data cleaning efforts

Cardiac and Vascular Group (CVG)

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. This group includes Aortic and Peripheral Vascular (APV), Cardiac Rhythm and Heart Failure (CRHF), and Coronary and Structural Heart products.

Within CVG, the Aortic and Peripheral Vascular (APV) Group offers treatment for vascular abdominal and thoracic aortic disease and interventional devices used to treat Peripheral Artery Disease (PAD) through catheter-based procedures and diagnostic technologies.

Medtronic is a $29.8b company with 90,000+ employees in more than 160 countries.

Come for a job. Stay for a career.

Must Have: Minimum Requirements

  • Bachelor's degree
  • 3 months + experience in clinical research field. (Master's Degree will substitute for one year of experience. Ph.D. or M.D. will substitute for two years of experience.)

Preferred Experience:

  • 2+ years of experience in clinical research field. (Master's Degree will substitute for one year of experience. Ph.D. or M.D. will substitute for two years of experience.)

  • Experience in IDE/Class III medical device clinical trials preferred

  • Knowledge of GCP, HIPPA, and Other Global Reporting Requirements

  • Knowledge of Aortic therapies

  • Successful cross functional team interaction and influencing skills

  • Ability to be a self-starter and work independently to achieve on time deliverables

  • Excellent oral and written communications

  • Effective interpersonal skills with the ability to influence and lead others who may or may not be part of direct team.

  • Results-oriented and a strong sense of urgency

  • Ability to prioritize rapidly

  • Strong problem solving skills

  • Excellent decision making/analysis skills

  • Excellent organizational skills

Location/Time zone:

This group is located in Santa Rosa, California. Remote workers will be considered but must work hours consistent with Pacific time core work hours. If a worker is remote, travel one week per month to Santa Rosa, California will be required.

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.

  • The employee is required to be independently mobile

  • The employee is required to interact with a computer, and communicate with co-workers

  • The employee is required to travel by car and by plane domestically and internationally 20%

Cardiac and Vascular Group (CVG)

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.

This group includes Aortic and Peripheral Vascular (APV), Cardiac Rhythm and Heart Failure (CRHF), and Coronary and Structural Heart products.

Within CVG, the Aortic and Peripheral Vascular (APV) Group offers treatment for vascular abdominal and thoracic aortic disease and interventional devices used to treat Peripheral Artery Disease (PAD) through catheter-based procedures and diagnostic technologies.

Medtronic is a $29.8b company with 95,000+ employees in more than 160 countries.

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 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.

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

DISCLAIMER:

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.

Come for a job. Stay for a career.


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Associate Clinical Research Specialist - Aortic And Peripheral Vascular

Expired Job

Medtronic Inc.