Clinical Trial Supply Coordination Assistant

Clinical Trial Supply Coordination Assistant needed for major pharmaceutical client in Indianapolis, IN!

Some aspects of the role are clerical (filing, correspondence), but overall job is much more complex. The focus is inventory management, so multitasking, attention to detail are extremely important.
Purpose of Position The Clinical Trial Materials Management (CTMM) department serves program teams, product teams, and affiliate customers by providing total study drug management and IVRS services. As part of the department, the Clinical Trial Supply Coordination (CTSC) Assistant manages study drug inventory for ongoing studies by using IVRS threshold parameters, spreadsheets, and other tools to optimize the use of study drug with the goal of eliminating out-of-drug calls due to avoidable circumstances. The CTSC assistant collaborates with the CTSC associate during the planning and ordering phase of the trial.
Position Responsibilities Typical responsibilities include: Inventory management
Participate in SDP process and meetings and PFT meetings, as appropriate
Provide inventory management expertise to IVRS setup process and meetings
Review and understand applicable sections of study protocols
Coordinate ancillary supplies, as necessary
Coordinate distribution of IVR training materials
Create and maintain inventory tracking tools as appropriate
Update tools, as necessary, based on changes from the study plan
Review IVRS inventory and confirm shipments needed
Collaborate with logistics assistants to understand distribution plan and requisite leadtimes
Initiate shipments of CT material and ancillary supplies to US investigator sites
Direct shipments by global affilates and distribution depots to OUS investigator sites
Ensure site/affiliate regulatory readiness prior to shipping and obtain appropriate documentation
Other study support activites
Review IVR worksheets and ensure proper set-up
Review fax re-order forms if applicable
Assist with ATM/startup meeting presentations
Escalate inventory, shipping, and temperature excursion issues as appropriate to CTSC Associates and Clinical Trial Project Managers (CTPMs)
Proactively identify ways to improve day-to-day activities and practices and actively communicate the opportunities to peers and leadership.
Participate in and/or support the implementation of local or divisional process improvement initiatives.
Stay abreast of cGMPs, GCPs, and other regulatory requirements to ensure activities stay in alignment withthem.
Use common sense and question poor business decisions.
REQUIREMENTS
Skills/Experience: A successful employee in this role would possess administrative support skills, the ability to use and apply multiple computer applications (e.g., MS Word, MS Excel, Access), the ability to manage multiple tasks, strong organization and self-management skills, strong teamwork/interpersonal skills, good attention to detail, and strong communication skills.
Education Required High school diploma or equivalent minimum