Clinical Operations Specialist 1

Roles & Responsibilities

• Collaborate with Clinical Study teams, Medical Affairs, and cross-functional stakeholders
• Support procurement and sourcing of study products, supplies, and vendors
• Develop and execute secondary labeling and packaging for clinical study products
• Inspect study products for compliance with SOPs and study requirements
• Manage study product and supply inventory using inventory management databases
• Assemble study kits, perform labeling, over-labeling, and documentation
• Ensure proper storage of study products under controlled temperature and humidity conditions
• Coordinate domestic and international packaging and shipping documentation
• Track shipments and maintain records in eTMF
• Manage return, reconciliation, and disposition of study products at study close
• Support transparency reporting for assigned studies

Experience Required

• Minimum 3 years of experience in clinical operations, medical device, pharma, or biotech
• Hands-on experience with clinical study supply management, labeling, packaging, and inventory
• Experience working in a regulated clinical research environment

Skills & Certifications

• Knowledge of Good Clinical Practice (GCP) and clinical trial regulations
• Strong inventory management and documentation skills
• Proficiency in MS Word, Excel (formulas), and databases
• Strong written and verbal communication skills
• Highly organized, detail-oriented, and process-driven
• Ability to work effectively in a matrix and cross-functional environment
• Comfortable handling physical tasks such as kitting and labeling

Eligibilities & qualifications

• Bachelor’s degree in Science, Engineering, Pharmacy, or related field
• Database experience is mandatory
• Ability to lift up to 30 lbs and perform repetitive labeling/kitting tasks