Clinical Research Coordinator I

Essential Functions (Principal Duties and Job Responsibilities):

• Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.

• Maintain required records of study activity including case report forms, consenting research subjects, or regulatory forms.

• Performs standard accounting functions, monitors and reviews accounting and related system reports for accuracy and completeness; prepares and reviews budget, revenue, expenses, invoices, and other accounting documents. Assist with reviews, analyzes and negotiates lab research budgets and contracts with sponsors under the direction of the Principal Investigator and Associate Director.

• Performs specific protocol procedures such as interviewing subjects, taking vital signs, and performing venipunctures. Direct the requisition, collection, labeling, storage, or shipment of specimens.

• Monitors study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.

• Schedules subjects for appointments and procedures as required by study protocols. Informs patients or caregivers about study aspects and outcomes to be expected.

• Assists with preparing IRB submissions, protocol revisions, and renewals as needed, and maintains copies of all IRB communications delegated by the Principal Investigator.

• Performs other related duties as assigned.

Knowledge, Skills and Abilities Required:

• Must possess a good working knowledge of basic clinical research practices.
• Must be proficient with personal computer.
• Ability to utilize keen judgment in evaluating information.
• Ability to numerically and accurately enter and calculate test results in an electronic database.
• Ability to work in a stressful environment.
• Must be team oriented.
• Accepts constructive criticism without issues.

Knowledge, Skills, Abilities Preferred:

• Knowledge of biospecimen collection, processing, labeling, aliquoting, storage, and shipment

• Knowledge of biobanking principles and specimen chain-of-custody procedures

• Familiarity with clinical laboratory operations and quality assurance practices

• Understanding of human subject protection regulations, HIPAA, and FDA regulations

• Familiarity with Laboratory Information Management Systems (LIMS)

• Experience handling blood, urine, saliva, and other human biological specimens

• Knowledge of centrifugation, pipetting, specimen processing, freezer inventory management, and cold-chain requirements

Education and Experience Required:

• Graduated from an accredited discipline specific program and licensed as phlebotomist/lab technician in the state of Tennessee. 60 months experience in a patient care or research setting required (clinical research experience preferred). 
• A Bachelor’s degree in a healthcare related field. Licensed phlebotomist preferred.

Education and Experience Preferred:

•  One (1) to two (2) years of experience in clinical research, translational research, or biomedical laboratory research

• Experience processing and handling human biological specimens

• Experience supporting observational studies, clinical trials, or biobank research

• Experience with specimen shipping in accordance with IATA regulations

• Experience with freezer inventory management and temperature monitoring systems

• Experience with REDCap, electronic medical records (EMR), CTMS, or laboratory information systems

Licensure, Certification or Registration Required:

• Current Basic Life Support (BLS) certification (or ability to obtain within 90 days of hire)

• Completion of Human Subjects Protection & Good Clinical Practice (GCP) training within 30 days of hire

• Completion of required institutional compliance training (e.g.