Clinical Research Associate II
2 weeks ago
Join Abbott Laboratories, a global healthcare leader, and contribute to the development of life-changing technologies that improve people's lives. Our diverse team of 114,000 colleagues serves people in over 160 countries, and we're committed to helping you grow and learn.
About the Role
We're seeking a highly skilled Clinical Research Associate II to assist in the clinical execution and management of all aspects of assigned clinical studies. This includes planning and implementation of clinical studies from concept to clinical study report, ensuring timely and quality delivery of study deliverables within agreed budgets and timelines.
Key Responsibilities
- Conduct single or multi-center medical device clinical studies, perform study site visits, and generate monitoring trip reports.
- Participate in study start-up activities, manage clinical monitoring activities, and ensure compliance to the Study Protocol, Good Clinical Practices (GCPs), ICH guidelines, Federal Regulations, and department procedures.
- Responsible for shipping study devices and supplies to clinical sites, performing study device accountability, and maintaining and auditing the Trial Master File to ensure inspection readiness.
- Review clinical data listings for completeness and accuracy, escalate issues to the Clinical Operations Manager as needed, and participate in cross-functional clinical teams in the planning and execution of clinical trials.
- Proactively and effectively communicate the status of clinical studies to management, ensuring quality delivery of study deliverables within agreed budgets and timelines.
Requirements
- 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.
Preferred Qualifications
- Demonstrated excellence in teamwork, shared mindset for success, stellar interpersonal and communication skills, and ability to solve problems with innovative solutions.
- 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 manage numerous projects/conflicting priorities, be flexible when priorities change, and have working knowledge of GCP, Clinical and Regulatory Affairs.
What We Offer
- Competitive salary range of $55,200.00 – $110,400.00, depending on location.
- Free medical coverage for employees* via the Health Investment Plan (HIP) PPO.
- Excellent retirement savings plan with high employer contribution.
- Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit.
- A company recognized as a great place to work in dozens of countries and named one of the most admired companies in the world by Fortune.
Apply Now
*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.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
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