Abbott

Clinical Research Associate II

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

Qualifications

  • BS degree in life sciences
  • 3+ years of experience as a CRA or CRC
  • Experience in conducting medical device or in-vitro diagnostics studies
  • Solid understanding of clinical trial process and regulations
  • Demonstrated problem-solving and project management skills

Responsibilities

  • Assist in planning and managing clinical studies
  • Conduct Site Qualification Visits and ensure site readiness
  • Present research protocols to stakeholders
  • Assist in training and selecting investigator sites and staff
  • Maintain Trial Master File for inspection readiness
  • Communicate study status effectively to management
  • Prepare required study documentation

Benefits

  • Opportunity to work in a leading diabetes care division
  • Engagement in innovative clinical research
  • Collaboration with cross-functional teams
  • Support for professional growth and development
  • Flexible daily activities with a moderate travel requirement
Full Job Description
JOB DESCRIPTION:

The Opportunity:

This position works out of our Alameda, CA location in the Diabetes Care division where we're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.

As the Clinical Research Associate II, you will assist in the clinical execution and management of assigned clinical studies. This includes but is not limited to planning and implementation of clinical studies from concept to clinical study report per timelines and quality standards. You will also present clinical study opportunities to potential research sites and evaluate their ability to conduct ADC research studies.

What you will do:
  • Participate in site selection and 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.
  • Present research protocols with a deep understanding of study criteria, visits, tasks and responsibilities.
  • As needed, assist senior staff in planning study conduct, selection and training of investigator sites, planning and running study meetings, evaluation, selection, and training of new study investigators.
  • Assist in the shipment of study devices and supplies to clinical sites and performing study device accountability.
  • Maintain and audit Trial Master File to ensure inspection readiness.
  • 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.
  • 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.
  • May be asked to perform other function-related activities in addition to the activities above.

Education and Experience
  • BS degree in life sciences with three years of experience as a CRA or CRC or combination of appropriate education and experience.
  • Preferred to have 3+ years of relevant experience in frequent sample testing studies, site monitoring, clinical trial practices and regulations.
  • Experience in conducting medical device and/or in-vitro diagnostics studies. Pharmaceutical background may also be considered.


Skills
  • Demonstrated excellence in teamwork, shared mindset for success, stellar interpersonal and communication skills including building rapport with team members, peers, and management.
  • Ability to understand and articulate complex study designs and requirements to investigators and study staff.
  • 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.

Travel Requirements
  • Must be able to travel 10-15%


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, 15 % 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)

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

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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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