Abbott

Clinical Research Associate II

Abbott • $81K — $141K *
Alameda, CA 94501In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • B.S. degree in life sciences or equivalent, with a minimum of 5 years in clinical research.
  • 2+ years of relevant experience in site monitoring required.
  • Experience with medical devices or in-vitro diagnostics studies preferred; pharmaceutical background may be acceptable.
  • Ability to travel 30-50% for study site visits.
  • Proficiency in clinical trial processes encompassed in regulatory and GCP standards.

Responsibilities

  • Conduct medical device clinical studies at single or multiple sites.
  • Perform regular study site visits, generate reports, and ensure action items are resolved.
  • Assist in the start-up activities of clinical studies.
  • Manage the shipping and accountability of study devices and supplies.
  • Ensure compliance with study protocols and regulatory requirements during monitoring activities.
  • Assist in planning study conduct, including CRF design and CRO management.
  • Maintain inspection readiness of the Trial Master File (TMF).
  • Review clinical data for completeness and escalate issues as necessary.
  • Communicate study status effectively to management and engage in cross-functional collaboration.

Benefits

  • Opportunity for professional development within a reputable team.
  • Contribute to innovative medical device studies impacting patient care.
  • Work in a dynamic environment with a commitment to quality and adherence to high standards.
  • Engagement with cross-functional teams that fosters collaboration and learning.
Full Job Description
JOB DESCRIPTION:

Clinical Research Associate II

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)

About Abbott

Abbott Careers

Joining Abbott means becoming part of a globally diverse team dedicated to making a lasting impact on human health. As a leader in healthcare innovation, Abbott provides a dynamic workplace where careers flourish through growth, leadership, and diversity training.

Opportunities at Abbott

Explore a world of opportunities with our team. Whether you're seeking job opportunities in engineering, marketing, research, or healthcare, Abbott offers a variety of positions that allow professionals to grow their careers. Our commitment to diversity and innovation is evident in every aspect of our work, fostering an inclusive culture that values each team member's contribution.

Work You'll Do

At Abbott, every role contributes to our mission of helping people live fuller lives through better health. From groundbreaking research in medical devices to advancements in pharmaceuticals, our team is at the forefront of healthcare innovation. By joining Abbott, you are not just accepting a job; you are embarking on a path of professional and personal growth.

Internship Programs

Kickstart your career with an Abbott internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at Abbott work on projects that matter, gaining the experience and knowledge necessary to succeed in their future careers.

Professional Development

Abbott is dedicated to the continuous professional development of its employees. With access to cutting-edge technology, leadership programs, and diversity training, our team members are equipped to lead and innovate within the healthcare industry. We support your career journey with robust training programs, mentorship, and opportunities for networking and professional growth.

Benefits and Culture

Our employees enjoy comprehensive benefits designed to support their life and well-being. From health insurance to retirement plans, we ensure our team has everything they need to thrive. Abbott's culture is built on a foundation of respect and integrity, united by a shared commitment to improving health outcomes.

Join Our Team

Discover the impact you can make with a career at Abbott. We are hiring individuals who are passionate, curious, and driven to lead. Search open positions that match your skills and interests on our Jobs page. Prepare your resume, sharpen your interview skills, and get ready to join a team that's at the cutting edge of healthcare solutions.

Stay Connected

Keep up to date with career tips, industry insights, and company news—all from the people who work here. Subscribe to our Careers Blog and personalize your subscription to receive job alerts and insider tips tailored to your preferences.

Explore Abbott

With a commitment to improving life through innovation, leadership, and diversity, Abbott is a place where you can fulfill your potential. See what exciting and rewarding opportunities await at Abbott by exploring our career opportunities today.

SEARCH ABBOTT JOBS

Join us in our mission to make the world a healthier place through innovation, leadership, and diversity. Your journey to a fulfilling career at Abbott starts here.
Learn more about Abbott
Size
113,000 employees
Market Cap
$189 billion
Industry
Healthcare
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ
ABT
* Ladders Estimates

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