2 Jobs in Alameda, CA
Abbott is Hiring a Clinical Research Associate II Near Alameda, CA
Working at AbbottAt Abbott, You Can Do Work That Matters, Grow, And Learn, Care For Yourself And 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.
- Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
- An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.
What You'll Work OnThe incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
- Conduct single or multi-center medical device clinical studies.
- Perform study site visits (SQV, SIV, IMV, COV), generate monitoring trip reports, and track resolution of action items.
- Participate in study start up activities.
- Responsible for shipping study devices and supplies to clinical sites and performing study device accountability.
- Manage clinical monitoring activities and overall site management ensuring compliance to the Study Protocol, Good Clinical Practices (GCPs), ICH guidelines, Federal Regulations, department procedures and applicable regulatory requirements.
- Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), conducting User Acceptance Testing (UAT), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions.
- Maintain and audit Trial Master File to ensure inspection readiness.
- Perform review of clinical data listings for completeness and accuracy, and escalate issues to the Clinical Operations Manager as needed·
- Participate in cross-functional clinical team(s) in the planning and execution of clinical trials.
- Proactively and effectively communicate the status of clinical studies to management.
- Ensures quality delivery of study deliverables within agreed budgets and timelines.
- Participate in the interim and final reviews of study data in preparation of regulatory submissions.
- Involved in the preparation of all applicable documents required for the conduct of the study (such as Trial Master File (TMF), Clinical Protocols and Reports).
- May interact with RA/QA in responding to audits and FDA inquiries
- BS degree in life sciences or equivalent with minimum 5 years of CRA or CRC experience, or combination of appropriate education and experience.
- Must have 3 years of relevant experience in site monitoring, clinical project management, clinical trial practices and regulations
- Demonstrated excellence in teamwork, shared mindset for success, stellar interpersonal and communication skills including building rapport with team members, peers, and management.
- Solid understanding and demonstrated experience of the clinical trial process including study design and conduct; clinical data management systems; clinical trial management systems; data analysis; and data reporting and interpretation.
- Must have a demonstrated ability to solve problems with innovative solutions along with strong project management and organizational skills to deliver projects on time and on budget.
- Able to manage numerous projects/conflicting priorities, and to be flexible when priorities change.
- Working knowledge of GCP, Clinical and Regulatory Affairs.
- Flexibility in daily activities.
- Proficient with Microsoft Suite.
- Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
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/Abbottand on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $65,900.00 – $131,900.00. In specific locations, the pay range may vary from the range posted.
Job Summary
Full Time
Transportation
$89k-121k (estimate)
06/04/2024
06/28/2024
abbott.co.nz
TORONTO, ONTARIO
25 - 50
1981
Private
JOHN J. HUMPHREYS
<$5M
Transportation
Related Companies
About Abbott
Abbott is a financial brokerage firm that offers business, personal and health insurance, and home loan services for individuals.
The job skills required for Clinical Research Associate II include Clinical Trial, Clinical Monitoring, Career Development, Clinical Operations, Planning, Organizational Skills, etc. Having related job skills and expertise will give you an advantage when applying to be a Clinical Research Associate II. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Clinical Research Associate II. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Clinical Research Associate II positions, which can be used as a reference in future career path planning. As a Clinical Research Associate II, it can be promoted into senior positions as a Scientist - Clinical Research that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Clinical Research Associate II. You can explore the career advancement for a Clinical Research Associate II below and select your interested title to get hiring information.
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