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Associate Clinical Site Lead â Northern CA

2 months ago

Fairfield, United States Abbott Laboratories Full time

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.

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve peopleâs health. Weâre always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youâll also have access to:

  • Career development with an international company where you can grow the career you dream of.
  • Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs. 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. An excellent retirement savings plan with high employer contribution
  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelorâs degree.
  • A company recognized as a great place to work in dozens of countries around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The Associate Clinical Site Lead for the Northern California region drives study execution and operational excellence across Abbott Cardiovascular therapies (Vascular, Cardiac Rhythm Management, EP, Structural Heart, and Heart Failure). Developing skills and foundation to become a resource in protocol execution, developing product and disease state knowledge, procedure support (as needed), procedure outcomes and early indication of trends, clinical trial enrollment, and ICH-GCP and clinical research application.

Adheres to specified site nomination, qualification, and startup processes. Leads ongoing training/retraining of all site stakeholders to ensure protocol adherence. Continuously reviews, manages, and influences all aspects of siteâs recruitment and data collection performance (enrollment, discrepancy resolution, compliance, etc.). Proactively utilizes appropriate operational metrics to minimize screen failure, attrition rate, etc. Monitors to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of site initiation, periodic, and close-out visits.

May be consulted in the following areas: study design, site payments, site audits, local document review, study documents preparation, and submission to site or competent authority/ethics committee.

What You'll Work On

With supervision of senior colleague/manager (or delegate):

Develop and maintain a productive clinical territory:

  • Identify, develop, and maintain sites capable of delivering start-up goals, study participation levels and required data quality.
  • Understand and assess investigatorsâ interests and qualifications.
  • Identify appropriate investigators as defined by study-specific requirements and by the applicable regulatory code.
  • Maintain open communication and relationships with key site personnel including the Principle Investigator, Research Coordinator, as well as regulatory and legal personnel.
  • Provide ongoing technical support to customers and field staff.
  • Facilitate communication between clinical sites and other Abbott clinical staff (e.g., operations management, study team, Site Contracts Associate), as needed.

Manage all aspects of study lifecycle to include site regulatory and quality:

  • Start Up
    • Nominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution.
    • Facilitate all aspects of the start-up process and site initiation visits
    • Understand regulatory and legal requirements for study participation at a level that allows for appropriate collaboration with Abbott clinical staff, e.g. Site CRA, Site Contract Associate.
    • Train facility staff regarding protocol requirements and technology.
  • Enrollment
    • Develop site-specific strategies to promote appropriate patient enrollment.
    • Identify site successes and challenges and assist in implementing techniques that promote study goal achievement.
    • Continuously evaluate site study performance and provide timely feedback to site.
    • Attend study procedures and follow-ups when indicated (or ensure trained personnel attend).
  • Regulatory and Quality
    • Strong understanding of GCP and commitment to progress knowledge and achieve Abbott certifications
    • Develop site-specific strategies to avoid deviations.
    • Educate site on tools to facilitate compliance.
    • Provide timely feedback to the sites on key compliance indicators.
    • Escalate non-compliant sites according to corporate policy.
    • Collect essential documents, identify and obtain missing data, data corrections, reviewing adverse events and protocol deviations.
    • Review data and source documentation from investigational sites for accuracy and completeness
    • Facilitate resolution of data queries and action items at clinical sites
    • Promptly reports the findings of monitoring visits according to Abbott processes.
    • Maintain accurate, detailed and complete records of monitoring visits.

Provide training and procedure coverage: 

  • Apply clinical and technical expertise to train site and Abbott staff for clinical trials and applicable commercial launches.
  • As needed, provide clinical and technical expertise for clinical trial procedure support
  • Attend study procedures and follow-ups (or ensure trained personnel attend). 

Collaborate with commercial partners:

  • When appropriate, collaborate in the education of local sales groups on new product launches.
  • When appropriate, contribute to the education of customers on new and existing Abbott products.
  • Meet with key customers where Abbott GCO presence can elevate the customer experience.
  • Act as an additional resource for technical questions and troubleshooting.

Identify and adapt to shifting priorities and competing demands. Remain current on developments in the field of expertise including clinical and Abbott product knowledge, competitive positioning and published scientific and economic evidence.

  • Maintain at least one area of expertise and function as a local clinical and technical resource.
  • Develop working knowledge of disease states and product lines for all relevant Abbott clinical trials.
  • Upon leadership approval, complete and maintain certifications that are relevant to specific field(s) of expertise (where appropriate).

Education and Experience Youâll Bring:

Required

  • Associateâs degree 
  • Minimum 1 year experience  

Preferred

  • Bachelorâs Degree in engineering, science, health science, nursing, or a related field, OR equivalent or related experience in cardiology or clinical research.
  • 2 years of progressively more responsible relevant clinical trial experience in the cardiovascular field. 
  • Competency in catheterization lab and operating room protocol and procedures.
  • Possess independent problem-solving skills and ability to make decisions.
  • Exhibit excellent oral and written communication skills.

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 and @AbbottGlobal.



The base pay for this position is $48,000.00 â $96,000.00. In specific locations, the pay range may vary from the range posted.