Biosample Operations Specialist

PRA HEALTH SCIENCES; United States; Remote; USD 60,000 - 90,000; Full time

Job summary

A leading company in the clinical trial space is seeking a Biosample Operations Specialist to manage biomarker laboratory samples. You will oversee sample collection, coordinate with study teams, and ensure compliance with regulations. This role is vital for supporting clinical trials and involves collaboration with various stakeholders to ensure sample integrity throughout various phases. Excellent organizational and communication skills are essential for success in this position.

Benefits

Annual leave entitlements

Health insurance options

Retirement planning offerings

Global Employee Assistance Programme

Flexible optional benefits

Qualifications

• Degree in life sciences field preferred.
• Experience in laboratory or clinical trial role.
• Knowledge of FDA & ICH/GCP regulations.

Responsibilities

• Plan and oversee operational activities for biomarker sample lifecycle.
• Collaborate with study teams and ensure GCP compliance.
• Interface with laboratory and vendors for sample management.

Skills

Critical reasoning

Problem solving

Excellent written communication

Organizational skills

Interpersonal communication

Education

Bachelor's degree in Biochemistry, Chemistry, Biology, Immunology, Medical Technology

Tools

Microsoft Office

Job description

Overview

The Biosample Operations Specialist is responsible for overseeing the biomarker laboratory samples for the client's clinical trials across the chain of custody from research site to the analysis laboratory. This role supports Study Teams across the portfolio of therapeutic areas.

Responsibilities

What you will be doing:

• Accountable for planning, coordinating and overseeing all operational activities required to manage the lifecycle of biomarker samples (oversight of sample collection at site, shipment to vendor for testing/processing, analysis and final sample disposition) ensuring sample integrity and GCP compliance throughout the process
• Collaborates with study teams and biomarker scientists to develop biological sample management plans in concurrence with sites, and central and specialized laboratories for all biomarker samples
• Reviews clinical study protocols, informed consent forms, laboratory documents, case report forms and service provider laboratory scope of work documents for sample handling details
• Interfaces with laboratory personnel, sample processing and other vendors to ensure proper shipment and receipt of samples, responding to issues as needed to ensure study objectives for clinical biomarkers are met
• Interfaces with laboratory personnel, sample processing and other vendors to ensure proper shipment and receipt of samples, responding to issues as needed to ensure study objectives for clinical biomarkers are met
• Works closely with study teams to manage monitoring of appropriate patient consent for all biosample collection and testing
• Ensures compliance with European GDPR requirements for personal information transmitted with biosamples

Qualifications

You are:

• Bachelor's degree in Biochemistry, Chemistry, Biology, Immunology, Medical Technology or related life sciences field highly preferred
• Experience working in a laboratory, research site and/or clinical trial management role at a biopharma company
• Working knowledge of FDA & ICH/GCP regulations
• Proven critical reasoning and problem solving skills
• Ability to oversee sample management activities across multiple projects, while maintaining electronic tracking system
• Excellent written, organizational and interpersonal communication skills necessary to collaborate and interface with outside vendors, consultants, and internal study team members (scientists, clinicians, clinical trial managers)
• Proficiency in Microsoft Office Applications including Excel, Word and PowerPoint

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.