Senior Associate Clinical Quality
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Job Location:
Des Plaines, IL - USA
Monthly Salary:
$ 75300 - 150700
Posted on:
11 hours ago
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
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. Youll also have access to:
Career development with an international company where you can grow the career you dream of.
Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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 bachelors 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
This position of Senior Associate Clinical Quality works out of our Lake Forest IL location in AMD Abbott Molecular Diagnostics. Our molecular division delivers best-in-class innovative testing solutions for people around the world to provide answers to lifes critical health decisions. We help people live full and healthy lives through our accessible molecular-based solutions.
What you will do
Provide global support to Clinical Development (CD) staff to ensure compliance with company policies GCP regulations/guidelines ISO standards and other applicable requirements. Clinical Study Support: Act as a reviewer of protocols informed consent forms case report forms and other essential study
documentation for product and process changes offer overall support to project teams in order to eliminate compliance risks; and
Represents Clinical Quality at project / protocol deviation meetings to maintain and promote quality and compliance within CD.
Compliance & Training
Advise CD staff on GCP guidelines ISO standards and departmental procedures.
Facilitate departmental training sessions.
Coordinate internal Continuous Improvement Detection (CID) and CAPA processes including approval of proposed actions and follow-up until closure.
Drive continuous improvement initiatives across CD.
Clinical Study Support
Review protocols informed consent forms case report forms and other essential study documents for product and process changes.
Provide compliance risk mitigation support to project teams.
Represent Clinical Quality in project and protocol deviation meetings to promote quality and compliance.
Audit & Inspection Support
Assist project teams and investigational sites in preparing for AQR audits or regulatory authority inspections.
Required Qualifications
Bachelors Degree Preferably in Life Sciences
Minimum 5 years medical devices clinical research experience or related industry.
Preferred Qualifications
Prefer at least 3 years of related work experience in Quality role in medical device area and/or clinical trial environment.
Prefer GCP audit experience. Specific requirements:
Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:
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 on Facebook at and on Twitter @AbbottNews.
The base pay for this position is
$75300.00 $150700.00In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Clinical Affairs / Statistics
DIVISION:
AMD Molecular
LOCATION:
United States > Des Plaines : DP01
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes 5 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: EEO is the Law link - Espanol: Experience:
Senior IC
Key Skills
- CSS
- Cloud Computing
- Health Education
- Actuary
- Building Electrician
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
