Clinical Trial Biospecimen Operations Specialist

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As the world’s largest FSP organization, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

We are seeking a Clinical Trial Biospecimen Operations Hybrid in Wilmington, DE.

What You Will Do:

• Play a key role in the communication and integration of translational medicine objectives with clinical study team members during protocol development and execution.
• Serve as a member of the Translational Medicine clinical study start team; support the tactical execution of biospecimen collection and analysis during clinical protocol development, study start-up and amendments, including contribution to and review of protocols, lab manuals, and clinical laboratory documents and communicate information as required to other departments, take part in program meetings with central lab, clinical, operations and data management.
• Contribute to activities involving the Data Management team, including eCRF set-up, database build for sites and sample tracking/reconciliation.
• Participate in efforts to standardize nomenclature, pictograms, sample handling instructions, and resources for all central labs to ensure consistency across studies, welcoming diverse perspectives, and inclusive practices.
• Coordinate with others within Translational Medicine group and external to the group to track and manage samples, projects, and deliverables.
• Aid in the process development and coordination of informed consent form tracking and clinical program sample storage/tracking using in-house and commercial systems.
• Participate in vendor meetings to stay informed of current and upcoming projects, innovative technologies, and vendor offerings.
• Solve problems independently, contacting internal or external clients as needed, while fostering a collaborative and inclusive environment.
• Must be able to prioritize workload in response to the specific needs of numerous protocols and department.
• Maintain awareness of local and international regulations as pertains to protecting the privacy of personal information that may be associated with clinical samples.
• Participate in process improvement initiatives. Plan and implement procedures and systems to maximize operating efficiency.

Your Profile:

• Scientific background (BS, RN, Med Tech) with a minimum of 2 years’ experience in clinical drug development, clinical trial execution, central lab study setup with exposure to biomarkers, pharmacokinetics or immunogenicity sample activities including sample collection procedures and logistics considerations, and exposure to informed consent language specific to the handling of human tissue specimens
• An understanding of the drug development process and familiarity with clinical labs and clinical trial sites
• Experience working with Contract Research Organizations (CRO)
• Demonstrated knowledge of ICH and GCP
• Advanced skills in Microsoft Office programs as well as good working knowledge of electronic data systems and controlled sample management systems
• Detailed and precise record keeping skills are essential as well as the ability to track and resolve issues.
• Must be comfortable with a hybrid role: reporting to Wilmington DE office a few days per week.
• Excellent teamwork and ability to collaborate with cross functional teams.
• Strong interpersonal, written, and verbal communication skills

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programs including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programs and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply.