1. Trial Master Files / Site Trial files: Work with study teams to identify TMF requirements and developing, maintaining, and archiving trial documentation in accordance with related SOPs working under minimal oversight.
2. Clinical Trial Materials / Binders / Labels: Work with study teams to identify specifications and develop study related materials to those specifications working under minimal oversight. May also assist in the maintenance and periodic review of
3. Receiving: Receives, inspects and inventories Clinical Trial Supplies insuring appropriate quality, quantities and storage conditions of materials / supplies, completing relevant documentation as necessary, and communications with Clinical Teams.
4. Picking / Packing / Shipping: Follows moderate to complex instructions from Clinical Team to fill shipping requests of Clinical Trial Supplies and/or Samples insuring accuracy of items and quantities, appropriate packing materials and shipping conditions (e.g., frozen, refrigerated and ambient), as well as shipping instructions to insure compliance with all DOT, IATA, and local and federal regulations.
5. Establish good working relationships across all Life Cycles and Facilities groups to effectively deliver work objectives.
6. Accurately and effectively communicate needs, issues, and project status with manager, Clinical Teams, Warehouse and Shipping staff.
7. Performs additional duties as requested by manager or designee.
1. Able to communicate clearly and accurately both written and spoken in English
2. Experience working as part of a team
3. Self-motivated and displays initiative
4. General knowledge of medical/scientific terminology and ICH/GCP guidelines
5. Detail oriented
6. Experience using copying / printing equipment
7. Experience using various computer applications including spreadsheets, email and word-processing software
Education High School graduate or equivalent required. Bachelor's Degree or undergraduate equivalent (scientific or healthcare discipline) preferred.