Clinical Research Coordinator I

This role supports the T4C initiative through specimen collection, processing, shipping, and tracking. The Clinical Research Coordinator I maintains lab inventory, ensures cleanliness and order, and operates lab equipment following biosafety guidelines, study protocols, and Meharry regulations. The position requires independent application of regulations governing human subjects protection, including IRB, FDA, OHRP, GCP/ICH, and HIPAA.

Responsibilities

• Assess eligibility of potential subjects through screening interviews, medical record reviews, and discussions with physicians and nurses.
• Maintain required records of study activity, including case report forms, consent documents, and regulatory forms.
• Perform standard accounting functions, monitor and review accounting reports for accuracy, and prepare budget, revenue, expense, and invoice documents.
• Assist with reviewing, analyzing, and negotiating lab research budgets and contracts under the direction of the Principal Investigator and Associate Director.
• Perform protocol procedures such as interviewing subjects, taking vital signs, and performing venipunctures.
• Direct the requisition, collection, labeling, storage, or shipment of specimens.
• Monitor study activities to ensure compliance with protocols and relevant local, federal, and state regulatory and institutional policies.
• Schedule subjects for appointments and procedures as required by study protocols.
• Inform patients or caregivers about study aspects and expected outcomes.
• Assist with preparing IRB submissions, protocol revisions, and renewals, and maintain copies of all IRB communications delegated by the Principal Investigator.
• Perform other related duties as assigned.

Requirements

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

Preferred Qualifications

• One to two 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.
• IATA Dangerous Goods Shipping Certification.
• Current CPR/BLS certification.
• Venipuncture certification or documented competency in specimen collection.

Skills

• Good working knowledge of basic clinical research practices.
• Proficiency with personal computers.
• Ability to evaluate information using keen judgment.
• Ability to accurately enter and calculate test results in an electronic database.
• Ability to work in a stressful environment.
• Team-oriented with the ability to accept constructive criticism.
• 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.

This position is funded through a grant and is contingent upon the availability of grant funding. Employment is expected to continue for the duration of the grant period, subject to satisfactory performance and continued funding availability.