[Remote] Associate Clinical Site Lead - Northern California at Abbott

California, United States

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, Clinical ResearchIndustries

Requirements

Developing skills and foundation in protocol execution, product and disease state knowledge, procedure support, procedure outcomes, early indication of trends, clinical trial enrollment, and ICH-GCP and clinical research application
Adherence to specified site nomination, qualification, and startup processes
Ability to lead ongoing training/retraining of all site stakeholders to ensure protocol adherence
Capability to continuously review, manage, and influence site’s recruitment and data collection performance (enrollment, discrepancy resolution, compliance, etc.)
Proactive utilization of appropriate operational metrics to minimize screen failure, attrition rate, etc
Monitoring to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of site initiation, periodic, and close-out visits
Strong understanding of GCP and commitment to progress knowledge and achieve Abbott certifications
Understand and assess investigators’ interests and qualifications
Understand regulatory and legal requirements for study participation to allow for appropriate collaboration with Abbott clinical staff (e.g., Site CRA, Site Contract Associate)

Responsibilities

Under supervision of senior colleague/manager (or delegate), drive study execution and operational excellence across Abbott Cardiovascular therapies (Vascular, Cardiac Rhythm Management, EP, Structural Heart, and Heart Failure)
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 including site regulatory and quality: Nominate, approach, and complete qualification processes; establish site/sponsor expectations; facilitate start-up process and site initiation visits; train facility staff on protocol requirements and technology
Develop site-specific strategies to promote appropriate patient enrollment; identify site successes and challenges; implement techniques to promote study goal achievement; continuously evaluate site study performance and provide timely feedback; attend study procedures and follow-ups when indicated (or ensure trained personnel attend)
Develop site-specific strategies to avoid deviations; educate site on tools to facilitate compliance; provide timely feedback on key compliance indicators; escalate non-compliant sites according to corporate policy; collect essential documents, identify and obtain missing data, data corrections, review
May be consulted on 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 managementregulatory compliancedata collectionenrollment managementGood Clinical Practicesite initiationsite qualificationstudy startupmetrics analysis

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

Is this role remote or does it require travel to sites in Northern California?

This information is not specified in the job description.

What are the main responsibilities of the Associate Clinical Site Lead?

The role involves driving study execution under supervision, developing site relationships, managing study lifecycle including startup and regulatory aspects, ensuring protocol adherence, and monitoring compliance with GCP and regulatory requirements.

What is the company culture like at Abbott?

Abbott is a global healthcare leader focused on helping people live more fully, with 114,000 colleagues serving over 160 countries through innovative technologies in diagnostics, medical devices, nutritionals, and medicines.

What makes a strong candidate for this Associate Clinical Site Lead role?

Strong candidates will have foundational knowledge in clinical research, ICH-GCP, protocol execution, site management, and the ability to build relationships with investigators and site personnel while ensuring regulatory compliance.

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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