Clinical Procurement Coordinator na None

Summary: The Equipment & Supplies Team support and manage three key areas of clinical equipment purchase and management to ensure the safe, reliable, and successful conduct of clinical drug and device research through the management and coordination of activities associated with the use of clinical equipment and supplies. Performs duties in accordance with ProSciento’s values, policies, and procedures. This is a part-time, non-benefitted role.

• Purchasing & Asset Management: Purchasing process for clinical equipment and supplies, asset and depreciation management; installation qualification and performance of clinical equipment. 
• Preventive Maintenance (PM) & Calibration (CAL): PM/CAL servicing schedules, shipping and receiving, document review and reconciliation, internal PM and CAL servicing on select ProSciento-owned equipment.
• Storage & Tracking: Location and tracking of clinical equipment and supplies across ProSciento site and equipment under Clinical Research Organization (CRO) Services.

Essential Duties and Responsibilities include the following. Other duties may be assigned at the Company’s sole discretion.

Purchasing & Asset Management:

• Reviews and assesses all purchase order requests for purchase of new or replacement clinical equipment and supplies. 
• Assists with or manages eMaint asset management system work orders and asset allocation.
• Interacts with service providers and all internal ProSciento departments that use clinical equipment.
• Assists with, manages, and oversees the process for handling of recalled clinical products, equipment, and supplies.
• Manages all clinical supplies in the stockroom and clinic and places orders accordingly to fulfill clinic needs.

Preventative Maintenance & Calibration:

• Provides support with the maintenance and calibration of all clinical equipment. Responsibilities include, but are not limited to:
  1. Supporting PM/CAL servicing activities that could include testing, calibrating, maintaining, repairing equipment such as refrigerators, freezers, clean rooms, and all equipment used directly in clinical trials.
  2. Facilitates routine preventative maintenance in conjunction with the relevant departments.
  3. Manages and oversees the charging of key clinical equipment on a daily basis (e.g., automated blood pressure machines and ECG machines.

• Manages and oversees the set-up and, where appropriate, calibration of key pieces of equipment (e.g. DEXA, YSI, Glucoscout – Algorithm).
• Coordinates and plans equipment validation activities with IT, QA, and CRU on management of computer or equipment systems for use within clinical trials.
• Manages service equipment used for calibration and preventive maintenance (e.g. NIST certified standards, measuring equipment).

Storage & Tracking:

• Manages clinical equipment location and maintains bar coding tracking system for supplies, where applicable. 
• Manages eMaint asset management system master equipment log/database inventory of equipment. 
• Manages daily equipment location within master equipment log/database.
• Manages equipment binders and files.

Temperature Charts & Logs:

• Reviews weekly and monthly temperature logs/charts for any discrepancies.
• Copies and scans temperature charts and logs into electronic scan folders.
• Files all temperature charts and logs.
• Requests and reviews all Notes To File (NTF) for any temperature chart and log discrepancies.
• Forecasts clinical supply needs.
• Identifies key personnel for appropriate installation, operational, and performance qualification.
• Manages ProSciento clinical equipment asset tag assignments.
• Manages and oversees the records and reports on equipment disposals.

• Manages and oversees the process for handling of recalled clinical products, equipment, and supplies.
• Manages and oversees the set-up and, where appropriate, calibration of key pieces of equipment (e.g. DEXA, YSI, Glucoscout – Algorithm).
• Coordinates and plans equipment validation activities with IT, QA, and CRU on management of computer or equipment systems for use within clinical trials.
• Manages service equipment used for calibration and preventive maintenance (e.g. NIST certified standards, measuring equipment).
• Manages clinical equipment and supply storage facilities.

Supervisory Responsibilities: 

Coordinator level:

Indirectly supervises employees in clinical departments for all aspects of equipment and supply management. Carries out indirect supervisory responsibilities in accordance with organizational policies and applicable laws. Responsibilities include planning, assigning, and directing work related to clinical equipment and supply management, including preventive maintenance, servicing schedules, installation qualification and performance as well as coordinating all key equipment activities with appropriate departments.

Manager level:

Directly supervises subordinate employees and indirectly supervises employees in the Clinical Research Unit (CRU) for all aspects of equipment management. Carries out direct and indirect supervisory responsibilities in accordance with organizational policies and applicable laws. Responsibilities include planning, assigning, and directing work related to clinical equipment management, including preventive maintenance, servicing schedules, installation qualification and performance as well as coordinating all key equipment activities with appropriate departments.

Competencies:

• Functional/Technical Skills: Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
• Informing: Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit, and/or the organization; provides individuals information so that they can make accurate decisions; is timely with information.
• Negotiating: Can negotiate skillfully in tough situations with both internal and external groups; can settle differences with minimum noise; can win concessions without damaging relationships; can be both direct and forceful as well as diplomatic; gains trust quickly of other parties to the negotiations; has a good sense of timing.
• Time Management: Uses his/her time effectively and efficiently; values time; concentrates his/her efforts on the more important priorities; gets more done in less time than others; can attend to a broader range of activities.
• Organizing: Can marshal resources (people, funding, material, support) to get things done; can orchestrate multiple activities at once to accomplish a goal; uses resources effectively and efficiently; arranges information and files in a useful manner.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty in accordance with statutory requirements and satisfactorily with regard to the duties and responsibilities described herein. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and Experience:

High school diploma or general education degree plus at least one-year work experience at ProSciento or previous experience in a procurement or administrative role. Minimum of 2 years’ experience working as a procurement coordinator. Minimum understanding of simple mechanics, electronic repair, and FDA clinical equipment regulations specific to clinical research (not manufacturing).

Certificates and Licenses: 

Certified Calibration Technician (CCT) preferred, but not required (manager level).

Language Ability:

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups or employees of organization.

Math Ability:

Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages. Ability to apply intermediate to advanced mathematical skills related to business accounting.

Reasoning Ability: 

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems and use critical thinking skills.

Computer Skills: 

To perform this job successfully, an individual should have knowledge of the current MS Office Word and advanced skills in MS Excel; NetSuite accounting software; and ADP or internal payroll systems management experience.