Job Description

The Clinical Research Coordinator I (CRC I) will be responsible for specimen collection, processing, shipping, and tracking for T4C initiative. The CRC I will be responsible for inventory and keeping the lab clean and orderly at all times. He/she will use lab equipment and supplies according to standard biosafety guidelines, study protocols and Meharry regulations. Functions independently, and is able to identify situations where additional support is necessary. Independently able to access regulations governing the protection of human subjects- IRB, FDA, OHRP, GCP/ICH and HIPAA guidelines and apply regulations in practice. The CRC I will assure that the integrity and quality of clinical research trials is maintained and the trials are conducted in accordance with all Meharry Medical College, IRB, and NIH policies and standard operating procedures. Responds to inquiries on study projects, ensures compliance of protocols and overall objectives, and performs study-related procedures of clinical research under the supervision of the Lab Manager, the Medical Director and Associate Director. The CRC I will assist with the operational and financial functions of the Clinical Research.

Position Summary:

The Clinical Research Coordinator I (CRC I) will be responsible for specimen collection, processing, shipping, and tracking for T4C initiative. The CRC I will be responsible for inventory and keeping the lab clean and orderly at all times. He/she will use lab equipment and supplies according to standard biosafety guidelines, study protocols and Meharry regulations. Functions independently, and is able to identify situations where additional support is necessary. Independently able to access regulations governing the protection of human subjects- IRB, FDA, OHRP, GCP/ICH and HIPAA guidelines and apply regulations in practice. The CRC I will assure that the integrity and quality of clinical research trials is maintained and the trials are conducted in accordance with all Meharry Medical College, IRB, and NIH policies and standard operating procedures. Responds to inquiries on study projects, ensures compliance of protocols and overall objectives, and performs study-related procedures of clinical research under the supervision of the Lab Manager, the Medical Director and Associate Director. The CRC I will assist with the operational and financial functions of the Clinical Research.

Daily Operations(Duties and 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:

• 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 criticisms.

Education and Experience:

• 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). OR: • A Bachelor's degree in a healthcare related field. Licensed phlebotomist preferred.

Job Tags

Full time, Local area,

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