Clinical Research Associate II
Read straight from Abbott's careers page, verified 8h ago.Seekless can tailor your résumé to it.
Seekless can write your résumé for this posting first.
Before you apply
Salary$82k – $141k
LocationUnited States - California - Alameda
Work modeon-site
Typefull-time
SeniorityMid
Experience5+ yrs
DepartmentMedical & Scientific Affairs
Company size10,000+ people
PostedOct 26, 2026 · 1w ago
Verified live8h ago
At a glanceSummarised by Seekless from the posting.
B.S. degree in life sciences or equivalent
Minimum 5 years of clinical research experience
Must have 2+ years of relevant experience in site monitoring
Experience in conducting medical device and/or in-vitro diagnostics studies preferred
Pharmaceutical background may also be considered
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
Proficient with Microsoft Suite
Must be able to travel 30-50%
Skills
Microsoft Suite
Benefits
Health insurance
Retirement savings plan
Tuition reimbursement
About the company
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 122,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
Clinical Research Associate II
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
The CRA II will assist in the clinical execution and management of all aspects of assigned clinical studies. This includes but not limited to planning and implementation of clinical studies from concept to clinical study report per timelines and quality standards.
This position will be based in our Alameda, CA office.
What You’ll Work On
•
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.
Required Qualifications
•
B.S. degree in life sciences or equivalent with minimum 5 years of clinical research experience.
•
Must have 2+ years of relevant experience in site monitoring.
•
Experience in conducting medical device and/or in-vitro diagnostics studies preferred. Pharmaceutical background may also be considered.
•
Must be able to travel 30-50%.
Preferred Qualifications
•
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.
•
Proficient with Microsoft Suite.
The base pay for this position is
$81,500.00 – $141,300.00
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:
No
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)Abbott 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