Investigational Device Coordinator

Concept Medical Inc.; Raleigh (NC); On-site; USD 42,000 - 63,000; Full time

Job summary

Concept Medical Inc. seeks a detail-oriented Investigational Device Coordinator to support device accountability and inventory coordination for IDE trials. The role is junior, with 1–2 years of clinical trial communication experience, and involves day-to-day IP tracking and inquiries from sites across Europe.

You will work with the Clinical Trial Manager to log shipments, maintain records, and be a responsive contact for site coordinators, ensuring compliance with GCP/GMP standards.

Qualifications

• 1–2 years of experience in clinical trial communication, coordination, or customer service in clinical research, pharma, or medical device settings.
• Bachelor’s degree (or equivalent) in Life Sciences, Business, Supply Chain/Logistics, or related field preferred.

Responsibilities

• Respond to site queries about device shipments, deliveries, and returns and escalate complex issues as needed.
• Monitor inbound/outbound IDE shipments between manufacturing site, warehouse, and clinical sites across Europe.
• Send shipment confirmations, delivery updates, and reminders to sites and couriers.
• Assist in coordinating the return of expired IP devices and used kits.
• Enter shipment, receipt, and return data into eCRF/inventory systems (e.g., Mednet) accurately.
• Conduct daily reconciliation of stock records and flag discrepancies for the supervisor.
• Maintain organized files of shipping manifests and receipts for audit readiness.
• Serve as a friendly first point of contact for site coordinators and liaise with warehouse staff and couriers.
• Help prepare routine inventory status reports for review by the Clinical Trial Manager and sponsor.

Skills

Clinical trial communication

Attention to detail

Organizational skills

English proficiency

Education

Bachelor’s degree in Life Sciences, Business, Supply Chain/Logistics, or related field

Tools

MS Office (Excel, Outlook)

eCRF platforms (Mednet, Rave)

Warehouse Management Systems (WMS)

Job description

We are seeking a detail-oriented Investigational Device Coordinator with hands-on clinical trial communication experience to support device accountability and inventory coordination for an IDE trial across Europe. This is a junior-level role suited to someone with 1–2 years of experience communicating with clinical sites, sponsors, or CROs, who is ready to take on day-to-day ownership of investigational device (IP) tracking and inventory-related correspondence. Candidate will work closely with a Clinical Trial Manager/Department to track IP shipments, maintain accurate accountability records, and serve as a responsive, informed point of contact for clinical sites regarding inventory queries.

Key Responsibilities

Inventory Communication & Coordination

• – Site Query Handling: Respond promptly and professionally to inbound queries from clinical sites regarding device shipments, deliveries, and returns, drawing on prior clinical trial communication experience to resolve routine issues independently and escalating complex cases to the senior Customer Success Executive.
• – Shipment Tracking Support: Monitor and log the status of inbound and outbound shipments of IDE devices between the manufacturing site, warehouse, and clinical sites across Europe.
• – Follow-Up Communication: Send shipment confirmations, delivery updates, and reminder notices to sites and couriers to keep the inventory pipeline moving smoothly.
• – Returns & Expiry Support: Assist in coordinating the return of expired Investigational Product (IP) devices and used kits from sites, under guidance from senior team members.

Data Entry & Record Keeping

• – eCRF/Inventory Data Entry: Accurately enter shipment, receipt, and return data into eCRF and inventory management systems (e.g., Mednet) in a timely manner.
• – Basic Reconciliation Support: Support daily comparison of warehouse stock records against system data, flagging any discrepancies to the supervising manager.
• – Documentation Filing: Maintain organized digital and physical files of shipping manifests, delivery receipts, and related paperwork to support audit readiness.

Stakeholder Support

• – First Point of Contact: Act as an initial, friendly point of contact for site coordinators on straightforward tracking and status questions, ensuring a positive customer service experience.
• – Internal Coordination: Liaise with warehouse staff and courier partners to relay shipment updates and help resolve minor delays or documentation gaps.
• – Reporting Assistance: Help prepare routine inventory status summaries and reports for review by the senior Customer Success Executive and sponsor.

Additional Responsibilities

• – Compliance Awareness: Follow established procedures for device handling, storage, and shipping documentation in line with GCP/GMP standards and applicable regulations.
• – Learning & Development: Build working knowledge of clinical trial logistics processes, temperature-controlled shipping requirements, and eCRF platforms.
• – Continuous Improvement: Flag recurring issues or process inefficiencies to the team and support the implementation of improvements.

Qualifications & Skills

• – Experience: 1–2 years of experience in clinical trial communication, coordination, or customer service within a clinical research, pharma, or medical device environment (e.g., site communication, trial supply/logistics coordination, or CRO/sponsor-facing support).
• – Technical Skills: Comfortable with MS Office (especially Excel and Outlook); willingness and aptitude to learn eCRF platforms (e.g., Mednet, Rave) and warehouse management systems (WMS).
• – Communication: Clear, professional written and verbal communication skills in English; comfortable corresponding with international site contacts across Europe.
• – Attention to Detail: Strong accuracy in data entry with the ability to spot and flag inconsistencies.
• – Attitude: Organized, proactive, and eager to learn, with the ability to follow structured processes and elevate appropriately when needed.
• – Education: Bachelor’s degree (or equivalent, in progress or completed) in Life Sciences, Business, Supply Chain/Logistics, or a related field preferred.