Clinical Trial Biospecimen Operations Specialist

Job ID: 035965 Req ID: 035965 Location: Wilmington, DE Hybrid

Sponsor-dedicated model supported by ICON’s global expertise as the world’s largest FSP organization, with over 90 sponsor partnerships. Hybrid role based in Wilmington, DE.

About the role

Play a key role in the communication and integration of translational medicine objectives with clinical study team members during protocol development and execution. Contribute to biospecimen collection and analysis activities throughout the clinical trial lifecycle, ensuring alignment with study objectives and regulatory requirements.

Responsibilities

• Serve as a member of the Translational Medicine clinical study start team; support tactical execution of biospecimen collection and analysis during protocol development, study start-up, and amendments, including contribution to and review of protocols, lab manuals, and clinical laboratory documents.
• Communicate biospecimen-related information to other departments and participate in program meetings with central lab, clinical, operations, and data management teams.
• Contribute to Data Management team activities, 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.
• Coordinate with internal and external stakeholders 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 while fostering a collaborative and inclusive environment.
• Prioritize workload in response to the needs of multiple protocols and departmental priorities.
• Maintain awareness of local and international regulations pertaining to the privacy of personal information associated with clinical samples.
• Participate in process improvement initiatives to maximize operating efficiency.

Requirements

• Scientific background (BS, RN, Med Tech) with a minimum of 2 years’ experience in clinical drug development, clinical trial execution, or central lab study setup.
• Exposure to biomarkers, pharmacokinetics, or immunogenicity sample activities, including sample collection procedures and logistics considerations.
• Experience with informed consent language specific to the handling of human tissue specimens.
• 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 guidelines.
• Advanced skills in Microsoft Office programs and working knowledge of electronic data systems and controlled sample management systems.
• Detailed and precise record-keeping skills, with the ability to track and resolve issues.
• Comfortable with a hybrid role, reporting to the 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.

Benefits

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

• 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.