Associate Clinical Research II

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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

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. 

What You'll Work On

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

• 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

• 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 team