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
The base pay for this position is
73,900.00 – 116,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Medical & Scientific Affairs
DIVISION:
ADC Diabetes Care
LOCATION:
United States > Alameda : Plaza 6 Building
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 25 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Work with human blood or other potentially infectious materialsAbbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
