Senior Clinical Research Associate - Abbott Point of Care (APOC)

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 109,000 colleagues serve people in more than 160 countries.

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 107,000 colleagues serve people in more than 160 countries

About Abbott

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott'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 Princeton, NJ currently has an opportunity for a Sr Clinical Research Associate.

We have a large amount of clinical study work needed to support regulatory submissions for both new cartridge product launches and our currently on-market cartridges. These studies are external IVD based performance studies (mainly US sites) and are being carried out with our 2 platforms (i-STAT 1 and Alinity). We need to hire CRA resources to support the many products and the tight timelines. The CRA resources will help us with all of the steps and tasks required to design, prepare for, execute, monitor and close IVD clinical studies. It is of significant benefit to identify CRA resources who have worn multiple clinical study hats (i.e., not just a data monitor as this is only one element) and are able to communicate well, pivot quickly and lead various IVD clinical study tasks from a sponsor point of view (CRO experience is okay, but the candidates should be prepared to adapt to a different structure). Screening for CRAs with sponsor initiated IVD, clinical study, test lab experience from science/health sciences backgrounds may help.

To collect and submit objective evidence of the performance of our products, CRAs need to:

• lead small groups, interact well with teams yet also be independent contributors
• depending on experience, be able to help new CRAs onboard/train
• have good communication skills (oral/written/presentations) and be able to deal with conflicts and resolution (especially when representing Abbott externally)
• be able to take responsibility for a number of studies/sites and provide updates to Management (depending on their level of experience)
• understand i-STAT IVD products (cartridges/samples/analyzers)
• understand preanalytical sample handling issues and be able to run various cartridges then train others and answer questions (be comfortable with this in-person/remotely)
• support the creation of the protocol and all of the associated study documentation (brochures, ICFs, CRFs, IRB submission pkgs etc); important for training and trouble-shooting with sites
• identify and prequalify/approve sites where the studies will be carried out
• support the creation of study specific electronic data collection fields and system elements (additionally be able to do user acceptance testing)
• support the creation of the clinical trial master file folders and system elements
• work with sites to ensure all of the documentation from sites is collected prior to starting the study and is also filed
• support preparation and execution for study site initiations, collecting documents, generating training modules etc
• understand and be able to carry out data/site monitoring both remotely and onsite
• support data verification and reviews to prepare collected data for analyses
• lead and work with sites for close out of the studies
• lead and carry out post study tasks regarding reports, trial master file documents, financial documentation etc
• be very organized and comfortable carrying out clinical study tasks remotely and on-site (travel, US)

In this role you

• Ensure compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of investigators/study coordinators, and follow-up of corrective actions.
• Ensure validity of study by identifying/resolving discrepancies and obtaining missing data and may track core lab activities and more complex components of the trial.
• Contributes to developing and writing clinical protocols, case report forms, and other study aids for investigational products by addressing issues by interacting with appropriate personnel.
• Maintain expertise in regulations for applicable geographies and types of studies (IDE, non significant risk, feasibility, exempt, etc.). Serves as a resource related to clinical trial regulations.
• Execution of all aspects of testing including design, developing test materials, protocols, evaluation of test data, and all around support of analysis. Responsible for the execution of all aspects of clinical studies including but not limited to: site selection, pre-study visits, essential document review, site close-outs.

Education and Experience:

• Require minimum 7 years relevant work experience or exposure to a technical / clinical environment, laboratory instrumentation and / or medical diagnostic testing.
• Knowledge of lab practices or point of care testing environments, regulations and standards affecting medical diagnostics, lab practices, familiarity with statistics and statistical software (desired).
• Bachelor's degree or equivalent experience required; prefer background in the sciences or a medically-related area (such as but not limited to Biology, Chemistry, Nursing, Medical Technology, Respiratory Therapy or related field of study).
• Excellent Communications skills, both oral and written.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We 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 future. Abbott 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.