Position : Clinical Operations Specialist

Location : Franklin Lakes, NJ

Duration : 7 Months

Total Hours/week : 40.00

1^st Shift

Client: Medical Device Company

Job Category: Medical / Clinical Affairs

Level of Experience: Entry Level

Employment Type: Contract on W2 (Need US Citizens or GC Holders Only)

Job Description:

Responsibilities:

• Collaborate with the Clinical Study team and Study Supply Group as required

• Assist with procuring study supplies, monitoring inbound shipments and accruing costs per study.
• Maintain Study Product and Study Supply inventory using Inventory management database. (Must be able to carry packages up to 30 LBS)
• Assist in assembly of kits, formatting and printing labels, over-labelling in accordance with protocol and product accountability practices.
• Inspect Study Product, including packaging and labelling per SOP requirements
• Oversight of the storage of Study Product and Study Supplies under secure, controlled conditions which are compliant with GCP and other applicable regulations and guidelines, and which adhere to the required limits of temperature and humidity.
• Assist in the disposition of product and/or supplies returned at the end of each study, including documentation, destruction, or restocking.
• Assist with packaging, shipment documentation and shipping of material (domestic and International)
• Tracking all inbound and outbound shipments
• Tracking Documentation and filing in eTMF

Experience

• A minimum AAS/BA/BS in Science, Engineering, Pharmacy, or other Allied Health professions
• Highly organized, detail oriented, and creative
• Excellent interpersonal skills
• Ability to perform under highly matrix environment, and able to thrive in a multidisciplinary team environment
• Knowledge of Good Clinical Practice (GCP), regulations and guidance relative to the conduct of clinical trials
• Proficient in Word Processing, Spreadsheets and Databases.
• Clinical Trial supply handling experience is preferred.
• Demonstrate experience in working on inventory management, and assembly of kits. Knowledge of clinical supply planning, manufacturing, packaging, and labelling.