Clinical Site Lead- Phoenix, AZ

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

Job summary

Abbott seeks a Clinical Site Lead in the United States to drive study execution across cardiovascular therapies. You will manage site recruitment, regulatory and quality processes, and collaborate with Abbott colleagues to ensure protocol adherence and data integrity.

The role requires travel up to 75% (including international), training of site staff, and engagement with investigators and regulatory personnel to optimize site performance.

Qualifications

• Associates Degree required.
• Minimum 1 year of experience.
• Bachelor’s or Master’s Degree in engineering, science, health science, nursing, or related field, or equivalent experience in cardiology or clinical research.
• 2+ years of progressively more responsible clinical trial experience in the cardiovascular field.
• Competency in catheterization lab and operating room protocol.
• Ability to travel approximately 75%, including internationally.

Responsibilities

• Develop and maintain a productive clinical territory and identify capable sites.
• Understand investigators’ interests and qualifications and maintain open communication with site personnel.
• Provide ongoing technical support to customers and Abbott staff.
• Collaborate with cross-functional teams to support site activities and study procedures.

Skills

Communication skills

Education

Associates Degree

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

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
• Enrollment
• Regulatory and Quality

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.

REQUIREDQUALIFICATIONS

Education

• Associates Degree(±13 years)

Experience/Background

• Minimum 1 year

PREFERRED QUALIFICATIONS

• Bachelor’s Degree Or Master’sDegree in engineering, science, health science, nursing, or a related field, OR equivalent or related experience in cardiology orclinical research.
• 2 + years of progressively more responsible relevant clinical trial experience in the cardiovascular field.
• Competency incatheterizationlab and operating room protocol and procedures.
• Ability to travel approximately 75%, including internationally.

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:

Clinical Affairs / Statistics

DIVISION:

MD Medical Devices

LOCATION:

United States of America : Remote

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