Clinical Site Lead - Boston, MA

Abbott Laboratories • Boston, MA

8h • $61,300 - $122,700

About The Position

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.
Summary
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.

Requirements

• Bachelors Degree (± 16 years) Related field OR an equivalent combination of education and work experience
• Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.
• Minimum 2 years Related work experience with a good understanding of specified functional area

Nice To Haves

• Bachelor’s Degree Or Master’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.

Responsibilities

• Develop and maintain a productive clinical territory:
• Manage all aspects of study lifecycle to include site regulatory and quality:
• Provide training and procedure coverage:
• Collaborate with commercial partners:
• 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.
• Possess independent problem-solving skills and ability to make decisions.
• Exhibit excellent oral and written communication skills.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level