Laboratory Coordinator

Summary: 

The Laboratory Coordinator is a research professional responsible for the laboratory activities associated with Javara’s in-clinic laboratory and phlebotomy services. With a guiding principle of research participant safety, the Laboratory Coordinator is responsible for promoting the mission of Javara and ensuring that the strategic integrity of the relationship between Javara and the healthcare organization and investigators within their region are upheld.  In this role, the Laboratory Coordinator must maintain compliance with regulations governing laboratory processing and shipping at all times.  

Essential Duties and Responsibilities:  

• Provides site support for blood and specimen collection in compliance with regulations and study protocols including completion of study specific trainings as required.

• Adheres to specimen preparation & shipment procedures as required by regulations and study protocols.

• Achieves quality results by participating in the quality assurance program. 

• Maintains medical laboratory equipment performance by establishing quality standards including management of calibration and equipment performance.  

• Certify instrument performance; working with Javara Clinical Services to address equipment replacement, service, and repair. 

• Maintains medical laboratory and clinical supplies inventory by checking stock to determine inventory level; anticipating needed supplies; placing and expediting orders for supplies; verifying receipt of supplies. 

•  Assist with other activities at the site to drive enrollment and quality as directed such as patient recruitment and data entry. 

• Ensure scientific integrity of data and record source data appropriately and accurately inclusive of patient visit data within source, CTMS, electronic reporting systems, completing the sponsor’s case report form, and timely query resolution. 

• Adhere to all Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), protocols, OSHA, proper PPE usage and other regulatory authority requirements. 

• Additional tasks as assigned. 

Qualifications: 

Required 

• Understanding of clinical trial processes, FDA regulations and ICH/GCP guidelines. 

• Strong familiarity with SOP’s, GCP’s guidelines and regulations pertaining to clinical trials. 

• Ability to lead cross-functional teams. 

• Ability to take initiative, problem solve, and work independently. 

• Strong team player, collaborative and able to build an effective team. 

• Excellent organizational and time-management skills, able to prioritize work to meet deadlines. 

• Accountable, dependable and strong commitment to quality of work. 

• Detail oriented with comfort working in a fast-paced environment. 

• Strong written and verbal communication skills. 

• Ability to use standard office software, as well as proprietary applications unique to the clinical trial industry. 

Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  

• This job operates in a professional environment. 

• The noise level in this work environment is usually light to moderate. 

Physical Demands: 

The physical demands described here are representative of those that must be met to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job. 

• The employee will regularly use hands to reach, handle or feel objects, tools, or controls and talk and hear. 

• The employee may frequently stand, walk and sit. 

• The employee may occasionally lift and/or move up to 25 pounds. 

• Specific vision abilities required include close vision, distance vision and the ability to adjust focus. 

Travel: This position may involve up to 30% travel. 

Pre-Employment Screening: Drug screen and background check required. 

This job description covers the most essential functions of this position and is not designed to contain a comprehensive listing of activities, duties or responsibilities that are required of the employee in this job. Duties, responsibilities and activities may change at any time with or without notice.