[Remote] Clinical Site Lead - Los Angeles at Abbott

California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, CardiovascularIndustries

Requirements

Recognized resource in protocol execution, product and disease state knowledge, procedure support, procedure outcomes, early indication of trends, clinical trial enrollment, 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
Core level Abbott certification and/or equivalent level proficiency
Understand and assess investigators’ interests and qualifications
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)

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; identify appropriate investigators; maintain open communication and relationships with key site personnel (Principle Investigator, Research Coordinator, regulatory and legal 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:
Start Up: Nominate, approach, and complete qualification processes including establishing site/sponsor expectations; facilitate all aspects of the start-up process and site initiation visits; 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: Develop site-specific strategies to avoid deviations; educate site on tools to facilitate compliance; provide timely feedback to 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 discrepancies
Drive study execution and operational excellence across Abbott Cardiovascular therapies (Vascular, Cardiac Rhythm Management, EP, Structural Heart, and Heart Failure)
May be consulted in study design, site payments, site audits, local document review, study documents preparation, and submission to site or competent authority/ethics committee

Skills

Key technologies and capabilities for this role

ICH-GCPclinical trial managementprotocol executionsite managementrecruitmentdata collectionregulatory complianceGood Clinical Practicesite initiationsite qualificationenrollment managementdiscrepancy resolutionstudy design

Questions & Answers

Common questions about this position

Is this a full-time position?

Yes, this is a full-time employment opportunity.

Where is this role located?

The position is based in Los Angeles.

What are the main responsibilities of the Clinical Site Lead?

The role involves driving study execution, managing site nomination, qualification, startup, training site stakeholders for protocol adherence, monitoring recruitment and data performance, and ensuring regulatory compliance.

What is Abbott's company background?

Abbott is a global healthcare leader with 114,000 colleagues serving people in more than 160 countries, offering life-changing technologies in diagnostics, medical devices, nutritionals, and branded generic medicines.

What experience or skills make a strong candidate for this role?

Strong candidates should have expertise as a recognized resource in protocol execution, ICH-GCP, clinical research, site management, regulatory requirements, and the ability to work with limited direction from leadership while maintaining relationships with key site personnel.

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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