Clinical Site Lead- Phoenix, AZ

Thornton Tomasetti; United States; Remote; USD 61,000 - 123,000; Full time

Job summary

Abbott is a global healthcare leader driving study execution and operational excellence across cardiovascular therapies. The Clinical Site Lead ensures protocol adherence, data quality, and enrollment performance, trains site stakeholders, and coordinates with Abbott staff to support trials and launches.

The role requires travel, regulatory expertise, and proactive data oversight to minimize screen failures and maintain compliance across sites in the United States and internationally.

Qualifications

• Minimum 1 year of relevant clinical trial experience.
• Knowledge of ICH-GCP and clinical research principles.
• Strong communication and training abilities.

Responsibilities

• Develop and maintain productive clinical territory and identify capable sites.
• Maintain communication with site personnel and provide technical support.
• Manage startup, regulatory, and site qualification processes.
• Develop site-specific enrollment strategies and monitor performance.
• Provide training for site and Abbott staff and collaborate with commercial partners.

Skills

Communication skills

Problem-solving

Travel willingness

Training capability

Clinical trial experience

Education

Associates Degree (± 13 years)

Bachelor’s or Master’s in engineering/science/health science/nursing or related field

Job description

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 115,000 colleagues serve people in more than 160 countries.

Job description

Clinical Site Lead 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.

Main Responsibilities

• 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.

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.

Other Responsibilities

• 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.

Required Qualifications

• Education: Associates Degree (± 13 years)
• Experience/Background: Minimum 1 year

Preferred Qualifications

• 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 catheterization lab and operating room protocol and procedures.
• Ability to travel approximately 75%, including internationally.

Salary

The base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.

Job Family / Division / Locations

• Job Family: Clinical Affairs / Statistics
• Division: MD Medical Devices
• Location: United States of America : Remote
• Additional Locations:
• Work Shift: Standard
• Travel: Yes, 75 % of the Time
• Medical Surveillance: Not Applicable
• Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.