Job details
Job type full-time
Full job description
Abbott is a global healthcare leader that helps people live more fully at all stages of lifeOur portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicinesOur 109,000 colleagues serve people in more than 160 countries.
About abbott
The key to successful treatment and full recovery is often fast, accurate diagnosisAbbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.
Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.
Our location in san diego, ca currently has an opportunity for a sr clinical research associate.
What you’ll do
Conduct monitoring visits and activities in accordance with fda code of federal regulations, gcp guidelines, departmental sops, work instructions and the clinical monitoring plan
Serve as primary site contact; establish and maintain regular communication with clinical sites
Conduct site-qualification, initiation, interim and closeout visits to include document review for accurate data recording, source data verification to protocol adherence and governing regulations
Assist with distribution, collection and tracking of regulatory documents for site compliance and audit readiness
Prepare and maintain monitoring visit reports and site communication documentation
Identify and resolve routine site issues, protocol deviations, queries, study discrepancies and collects missing or incomplete information
Facilitate subject recruitment and retention programs
Identify and resolve site issues
Proficient use of, and capability to train others, on edc systems
Provide leadership/ training/mentoring of cras and ctas
Provide input and help facilitate the development of site monitoring plan, informed consent forms, source document templates, case report forms and other study related documents
Communicate to ctm any observed study trends
Develop clinical trial documents as requested by ctm
Quality control review of clinical study reports, tables, listings and figures as requested
Work with minimal supervision
Work on multiple projects simultaneously
Additional project and tasks as determined by department and organizational needs
Travel may be approximately 30%
Education and experience you’ll bring
Required
Minimum ba or bs in related field and 5 years of related experience
Preferred
On-site monitoring experience of ivd clinical studies is preferred
Advanced knowledge of clinical trial practices and regulations
Advanced knowledge of clinical monitoring and trial design
Working knowledge of clinical trial databases
Advanced technical writing
Proficient computer skills including microsoft office suite
Competencies
Leadership
Collaboration
Communication
Interpersonal skills
Influencing skills
Relationship building
Teamwork
Troubleshooting skills
Technical writing skills
What we offer
At abbott, you can have a good job that can grow into a great careerWe offer:
Training and career development, with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives and retirement plans
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: http://www.abbottbenefits.com/pages/candidate.aspx
Follow your career aspirations to abbott for diverse opportunities with a company that provides the growth and strength to build your futureAbbott is an equal opportunity employer, committed to employee diversity.
Connect with us at www.abbott.com, on facebook at www.facebook.com/abbott and on twitter @abbottnews and @abbottglobal.
An equal opportunity employer, abbott welcomes and encourages diversity in our workforce.
