Clinical Lab Coordinator

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.

Duties & Responsibilities

• 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

Clinical Scheduler tasks

• 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

Clinical Data Entry tasks

• 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

Clinical Administrative Assistant tasks

• 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

Clinical procedure tasks

• 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

Clinical Lab Devices tech tasks

• 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)

Minimum & Preferred Qualifications and Experience:

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

Minimum Qualifications

• Excellent communication skills (both written and oral);
• Direct experience in customer interactions and presentations;
• Ability to be an integral part of an innovative, fast paced Product Development Team;

Preferred Qualifications

• Certified Phlebotomist
• Medical Assistant License
• Three years or more of related experience and/or training; or equivalent combination of education and experience;

Education

High School graduate or GED required. Bachelors/Masters may be preferred depending on position level. Physical requirements/Work Environment

Compensation: The anticipated range for this position is $20. - $29 per hour. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience.

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver's license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.