[Hiring] Associate Clinical Site Lead @Abbott

Role Description

The Associate Clinical Site Lead for the Atlanta, GA 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 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.

Qualifications

• Required: Associate’s degree.
• Minimum 1 year experience.
• Preferred: 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 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.

Requirements

• 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.
• Maintain open communication and relationships with key site personnel including the Principal 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.
• Facilitate all aspects of the start-up process and site initiation visits.
• Train facility staff regarding protocol requirements and technology.
• Develop site-specific strategies to promote appropriate patient enrollment.
• Continuously evaluate site study performance and provide timely feedback to site.
• Attend study procedures and follow-ups when indicated (or ensure trained personnel attend).
• Strong understanding of GCP and commitment to progress knowledge and achieve Abbott certifications.
• Collect essential documents, identify and obtain missing data, data corrections, reviewing adverse events and protocol deviations.
• Maintain accurate, detailed, and complete records of monitoring visits.
• Provide training and procedure coverage.
• Collaborate with commercial partners when appropriate.
• Identify and adapt to shifting priorities and competing demands.
• Maintain at least one area of expertise and function as a local clinical and technical resource.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical 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 bachelor’s 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.