Clinical Operations Specialist

Position : Clinical Operations Specialist

Location : Franklin Lakes, NJ

Duration : 5 Months

Total Hours/week : 40.00

1st Shift

Client: Medical Device Company

Job Category: Medical / Clinical Affairs

Level of Experience: Mid-Level

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

Job Description:

Responsibilities:

• Exercise good judgment in completing tasks on time, managing work tasks, prioritization of work, etc.
• Proactively maintain open lines of communication, and act as a liaison among a number of internal groups and services.
• Manage multiple activities and functions daily.

• Responsible for assembly of different medical device kit configurations and quality checks of finished product.

• Maintain Study Product and Study Supply inventory using Inventory management database. (Must be able to carry packages up to 25 LBS)

• Pick/fill site orders from inventory

• Pack shipments, create shipment documentation.
• Formatting and printing labels, over-labelling in accordance with protocol and product accountability practices.

• Routinely perform and record physical inventory of a small clinical trial inventory area.
• Maintain Study Product and Study Supply inventory using Inventory management database.
• Inspect Study Product, including packaging and labeling 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.

• Tracking all inbound and outbound shipments
• Collaborate with the Clinical Study team and Study Supply Group as required
• Ability to maintain spreadsheets and other reports required by management.

Experience:

• Working knowledge of Microsoft Office required
• Experience with printing labels & document formatting preferred.
• 3+ years of administration experience required.
• Inventory experience preferred.
• Practical, professional, detail oriented, flexible and dedicated team player capable of working independently.
• Must be capable of lifting/moving up to 25lbs
• 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
• Proficient in Word Processing, Spreadsheets and Databases.