Clinical Study Assistant Apply
Roles and Responsibilities:-
- Collaborate with the Clinical Study team and Study Supply Group as required
- Maintain Study Product and Study Supply inventory using Inventory management database.
- Assist in assembly of kits, formatting and printing labels, over-labelling. Developing clear and efficient study product secondary labeling and packaging designs in order to facilitate study execution, protocol compliance, and product accountability.
- Inspect Study Product, including packaging and labeling per SOP requirement
- Maintain and calibrate instruments to monitor clinical inventory conditions.
- Oversee 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 destruction or restocking.
- Assist with packaging and shipping of material (International, Domestic) IATA certification not required but a plus.
Education and Experience:-
- A minimum of 2 years' experience in a Medical Device Clinical Trials, pharmaceutical, biotechnology or related firm, including direct exposure to the process of clinical trial study supply management and execution.
- A minimum BA/BS in Science, Engineering, Pharmacy or other Allied Health professions.
- Knowledge of Good Clinical Practice (GCP), regulations and guidance relative to the conduct of clinical trials.
- Proficient in MS Word Processing (Mail Merge experience a plus), Spreadsheets (Must be able to use formulas in Excel) and Databases (front end data entry).
Skills:-
- 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.
