Clinical Lab Coordinator II

Job Summary

The Clinical Lab Coordinator is responsible for support and maintenance of engineering clinical studies in the laboratory setting. Job duties may include some, if not all the responsibilities listed below.

• Understand and be knowledgeable in study protocols
• Maintain confidentiality of proprietary and subject information
• Ensure adherence to quality standards, deadlines, and proper procedures
• Effectively sort, comprehend, and decipher large amounts of information
• May help support study activities in a lab setting including running blood samples, pregnancy tests, and helping with subject’s paperwork
• Perform other duties as required including but not limited to creating data queries, responding to Engineering subject demographics request, and other forms of data inquiries
• Act as a liaison in dealings between vendors and clinical lab when necessary
• May assist in other administrative roles as needed
• May be required to travel based on business needs

• Phone screen and evaluate candidates to determine eligibility for ongoing protocols and explain study procedures
• Manage appointments and confirmations using scheduling databases and notification services including follow-ups

• Data entry, verification and transfer from various sources (paper, electronic...) and create queries to capture missing elements.
• Create study logs and assist in various aspects of clinical monitoring

• Create purchase orders, process invoices, place, schedule, and follow-up on orders to ensure accuracy and timely delivery;
• Provide ongoing budgeting support
• Request, receive and maintain supplier quotes; including scheduling of vender on site visits
• Receive and review requisitions requesting goods and verify compliance with corporate policy;
• Monitor performance, qualifications and capabilities of vendors to ensure maintenance of delivery, quality, and price commitments;
• Maintain inventory and inventory logs based on expiration dates;
• Communicate with staffing agency to schedule medical / temporary staff; and review and approve time cards
• Assist in onboarding process of new hires
• Ensure training records, CVs, certifications and licenses are up to date

• Conduct a broad range of clinical trial duties, including equipment setup and operations, execution of studies according to test protocols/procedures and clinical work instructions, consenting subjects, sensor placement, collect data, verify results and transfer data.
• Maintain and/or manage device accountability.
• Maintain and/or manage maintenance of equipment records and calibration records for equipment (including laboratory analyzers)
• Assist in blood draws and analysis of blood samples
• Ensure weekly protocol capacity demands are met through efficient and accurate subject and clinical staff scheduling
• Leadership and supervision maybe required for various levels

• Maintain equipment and procedures in lab setting
• Assure proper use of sensor/ test equipment during clinical lab testing
• Maintain lab stock of supplies for analyzer consumables
• Calibrate lab equipment on a regular schedule
• Ensure proper documentation and maintenance of equipment records and calibration records for equipment (including laboratory analyzers)
• Coordinate equipment and supplies necessary for research studies;
  Set up system to facilitate raw data collection as directed
• Participates in bioanalytical monitoring/ auditing activities
• Responsible for the proper handling and disposal of biohazardous materials
• Execution of various wet lab activities which require the use of spectrophotometers, pipettes, cleaning procedures and hazardous materials (e.g. quantify hemoglobin, proteins and carbohydrates via chemistry assays)

Position Levels(Commensurate with education, skillset, experience and level of responsibilities, years of experience are indicated as a general guideline and are not mandatory):

• Clinical Lab Coordinator I
• Clinical Lab Coordinator II
• Senior Clinical Lab Coordinator
• Clinical Lab Coordinator Supervisor

• Exce…