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Form of workAssists Clinical Research Associates (CRAs) and Study Managers (SMs) in the coordination of all aspects of external evaluations for both non-clinical and clinical studies. This function includes assisting, as needed, in all tasks required for initiating, monitoring and successfully completing clinical trial projects. The main responsibility is the coordination, tracking of all supplies, samples, and data coming to/from the external sites. Coordinates a defined function or process within the assigned area. May supervise people with responsibility for a process, and oversight of day-to-day operations. Typically just above entry level of most professional job families Requires in-depth knowledge of a process or function. Generally requires an advanced education or training. Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions. Knowledge Skills and Attributes Bachelors degree in relevant field (Life Sciences preferred) with 1-2 years experience minimum. Knowledge of applicable standards and regulations for clinical trial and lab conduct Excellent oral and written communication skills Excellent planning, organizing, interpersonal and leadership skills Ability to work independently to make sound decisions and analyze and solve problems Demonstrated experience in computer skills to include Microsoft Word, Excel and basic templates and statistical knowledge. Additional Skills: Lab work/Clinical Trial Computer experience Fit into culture Life Science experience a plus Experimentation experience a plus Jr. or Season candidate Optimatization experience Some lifting (20-25lbs) Position is 3-6 months duration Flexible hours, no weekends Freezer/Bio hazard environment (frozen) Must wear PPE when handing materials
Key Roles and Responsibilities 1. Ensure project related data is accurate and assist in data maintenance. 2. Responsible for records maintenance, coding of samples and storage of approved materials. Maintains shipping/receiving records and clinical supplies database. 3. May assist with development of project plans and schedules. Part of Core Clinical Operations team. 4. Coordinates all logistics aspects of a small project or phases of a larger project, ensuring all project objectives are met and business goals are achieved. 5. Supervises data entry, kit builder and logistics personnel. 6. Responsible for ordering and shipping supplies/samples in coordination with all phases of the clinical studies. Maintains files and inventories of chemicals, supplies and equipment. Ensures proper reagent/control/sample shipments and returns and assists with in-house reconciliation. 7. Coordinate all aspects of laboratory equipment maintenance including the alarm system, calibration, validation and shipment to sites. 8. Ensure the lab is in compliance thru weekly tasks and monthly inspections. 9. Builds key relationships with *** stakeholders in shipping and receiving.
