Clinical Research Associate I at Abbott

Alameda, California, United States

Apply Now

Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, DiagnosticsIndustries

Requirements

BS degree in life sciences preferred or equivalent with minimum one (1) year of clinical research experience, or combination of appropriate education and experience
Experience working on medical device studies and/or in-vitro diagnostics studies preferred. Pharmaceutical background may also be considered
Demonstrate excellence in teamwork, solid interpersonal and communication skills including building rapport with team members/peers, study site staff, and clinical management
Working knowledge of CFR, ICH-GCP, Clinical and Regulatory Affairs
Proficient with Microsoft Suite
Must be able to travel 30-50%, with additional travel as required

Responsibilities

Perform study site visits (SQV, SIV, IMV, COV), generate monitoring reports, and track resolution of action items
Assist and conduct clinical monitoring and site management activities, ensuring compliance to the Study Protocol, Good Clinical Practices (GCPs), ICH guidelines, Federal Regulations, department procedures, and other applicable regulatory requirements
Participate in study start up activities
Assist with shipping study devices and supplies to clinical sites
Perform study device accountability and reconciliation
Assist senior staff in development of study-specific forms and trial-specific monitoring plans
Assist senior staff in study planning, designing case report forms (CRFs), and training of study sites
Maintain and audit Trial Master File (TMF) and upload to eTMF to ensure inspection readiness
Perform review of clinical data listings for completeness and accuracy; and escalate issues to the Clinical Operations Manager/Study Lead as needed
Proactively and effectively communicate the status of clinical studies to management
Participate in the interim and final reviews of study data in preparation of regulatory submissions
May interact with RA/QA in responding to audits and FDA inquiries
Perform any other duties as assigned by management

Skills

Clinical Research

GCP

ICH Guidelines

Site Monitoring

Study Protocol Compliance

Clinical Trial Management

SQV

SIV

IMV

COV

ISO14155

Federal Regulations

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.

Land your dream remote job 3x faster with AI

Try Jobo Free