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About the Role

The Senior Clinical Site Lead drives study execution and operational excellence across Abbott Cardiovascular therapies. This role is a recognized resource in protocol execution, product and disease state knowledge, procedure support, clinical trial enrollment, and ICH-GCP application.

Responsibilities

Develop and maintain a productive clinical territory by identifying, developing, and maintaining 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.
Provide ongoing technical support to customers and field staff.
Facilitate communication between clinical sites and other Abbott clinical staff.
Manage all aspects of study lifecycle to include site regulatory and quality.
Facilitate all aspects of the start-up process and site initiation visits.
Understand regulatory and legal requirements for study participation.
Train facility staff regarding protocol requirements and technology.
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.
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.
Apply clinical and technical expertise to train site and Abbott staff for clinical trials and applicable commercial launches.
Provide clinical and technical expertise for clinical trial procedure support.
Collaborate in the education of local sales groups on new product launches.
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.
Possess independent problem-solving skills and ability to make decisions.
Exhibit excellent oral and written communication skills.

Requirements

Bachelor's degree in engineering, science, health science, nursing, or a related field.
2 years of progressively more responsible relevant clinical trial experience in the cardiovascular field.
Ability to travel approximately 50%.

Skills

Protocol execution
Product knowledge
Disease state knowledge
Procedure support
Clinical trial enrollment
ICH-GCP
Clinical research application
Site nomination
Site qualification
Site startup processes
Training
Data collection performance
Recruitment
Operational metrics
Regulatory requirements
Good Clinical Practice
Accuracy standards
Site initiation
Periodic visits
Close-out visits
Study design
Site payments
Site audits
Local document review
Study documents preparation
Submission to site or competent authority/ethics committee
Catheterization lab protocol and procedures
Operating room protocol and procedures

Location

Cleveland, OH
Buffalo, NY
Remote

Work Type

Remote
Full-time

Experience Level

Senior

Education Level

Bachelor's degree

Salary/Compensations

$78,000.00 – $156,000.00

Benefits

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 high employer contribution.
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit.
Health and wellness benefits

About the Company

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 122,000 colleagues serve people in more than 160 countries.
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.

Equal Opportunity

Abbott is an Equal Opportunity Employer, committed to employee diversity.
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.