Clinical Research Coordinator

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.

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. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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 bachelors 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

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. Were revolutionizing the way people monitor their glucose levels with our new sensing technology.

This position will provide clinical operational support to assigned clinical studies and projects. Interact with other departments and external suppliers and provide logistical support to clinical research teams. Perform responsibilities meeting project commitments and in compliance with applicable regulations, good clinical practice (GCP) and standards.

What Youll Work On

• Responsible for implementing and maintaining the effectiveness of the quality system.
• Conducts assigned clinical operations activities in accordance with applicable regulations; GCP, policies and procedures. May include the following activities:
• Facilitating the execution of new CDAs and Clinical Research Agreements and amendments
• Process and track payments related to executed Clinical Research Agreements
• Coordinate denied party screening and maintain reports and financial disclosures
• Coordinate orders and ship clinical supplies, instruments and specimens to sites for clinical studies
• Support internal audit and other compliance-related activities (e.g. preparation for audits, QA verification of clinical data, OEC review of Scientific Research and Publications, tracking of supplies for Sunshine Act reporting)
• Provide clinical study support to CRAs (e.g. prepare study master file binder, route clinical records, complete study-related exception reports)
• Supports clinical research team with review and monitoring of clinical study data
• Identify the need for new processes and technologies to support an increase in quality, productivity and efficiency
• Identify and participate in process improvement initiatives. May participate in a lead role for a project
• Participate in training and educational opportunities for personal development and cross-training within the organization
• Support current and new processes and procedures for the Clinical Research organization in accordance with applicable regulations; GCP; and ADD policies and procedures. This may include:
• Development and maintenance of Clinical Research procedures, templates and forms
• Routing of clinical procedures in APLM
• Support of new processes and technologies to support quality, productivity and efficiency of the Clinical Research organization
• Supervisory/Management Responsibilities: None
• Position Accountability/Scope
• Accountable for completing operations activities per project timelines and elevating issues or concerns to appropriate management representatives with potential corrective actions identified. Responsible for compliance with applicable procedures, regulations and standards.
• This position performs tasks and responsibilities under the general direction of the Clinical Operations Manager or Clinical Research Manager.

Required Qualifications

• BS degree in Biological Science or Medical Specialty preferred
• Minimum Associate's degree required.
• Knowledge of regulations and standards (GCP) affecting IVDs and Biologics required.
• Minimum 3 years related experience in a clinical research environment or a research laboratory with automated IVD assay/instrument experience, including data analysis.
• Experience with contracts and knowledge of electronic document management systems (e.g. APLM, SBM and other databases) desired.

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. 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.

The base pay for this position is $72,100.00 $114,700.00. In specific locations, the pay range may vary from the range posted.