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Clinical Site Lead (Kentucky Region)

Abbott Laboratories

This is a Full-time position in Lexington, KY posted May 10, 2021.

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.

Job Description

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ?ngersticks.

Our location in Kentucky Region, currently has an opportunity for a Clinical Site Lead

The Clinical Site Lead drives study execution and operational excellence across Abbott Cardiovascular therapies (Vascular, Cardiac Rhythm Management, EP, Structural Heart, and Heart Failure). Recognized resource in protocol execution, increasing 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 site’s 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 DO

With limited direction from leadership:

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 investigators’ 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
    • Core level Abbott certification and/or equivalent level proficiency
    • 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).

Possess independent problem-solving skills and ability to make decisions.

Exhibit excellent oral and written communication skills.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

  • Bachelor’s 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 catheterizaion lab and operating room protocol and procedures.
  • Ability to travel approximately 75%, including internationally.

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:  www.abbottbenefits.com

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