Clinical Research Associate I (Start Up Focus)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Clinical Research Associate I (Start Up Focus)

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

Supports clinical trial start-up activities, including investigator debarment checks, regulatory document collection, study file preparation, site qualification visits, and site selection support.

This position will be based in our Alameda, CA office.

What You’ll Work On

• Participate in study start up activities, to include but not limited to, conducting investigator debarment checks, collection of regulatory documents and preparing the study files.
• Conduct Site Qualification Visits (SQV) and reporting to ensure study staff and research site are adequate to perform ADC trials.
• Assist with shipment of study devices and supplies to clinical sites and maintain communication with the device group as required.
• Responsible for assisting senior study startup staff during site selection
• Maintain and audit Trial Master File and upload to Veeva Vault to ensure inspection readiness.
• Proactively and effectively communicate the status of clinical trial start up to management.
• Support regulatory submissions
• Perform any other duties as assigned by management.
• Must be able to travel 30-40%

Required Qualifications

• BS degree in life sciences preferred, with two years of experience as a CRC/CTA or combination of appropriate education and experience.
• Experience in conducting medical device studies preferred, pharmaceutical background may also be considered.
• Perform any other duties as assigned by management.

Preferred Qualifications

• Demonstrated excellence in teamwork, stellar interpersonal and   communication skills including building rapport with team members, peers, and management.
• Working knowledge of GCP, Clinical and Regulatory Affairs.
• Flexibility in daily activities.
• Proficient with Microsoft Suite

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

Divisional Information

Medical Devices

General Medical Devices:

Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders