Clinical Operations Specialist - Urgent Need
Clinical Operations Specialist - Urgent Need
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Salary Not Disclosed
1 Vacancy
Job Description
Position : Clinical Operations Specialist
Location : Franklin Lakes NJ
Duration : 7 Months
Total Hours/week : 40.00
1st 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 overlabelling 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.
Required Experience:
Unclear Seniority
Employment Type
Full Time
