Clinical Research Coordinator II

2 weeks ago

Nashville, United States Meharry Medical College Full time
The Clinical Research Coordinator II (CRC II) will be responsible for coordinating advanced clinical research projects proficiently with supervision. 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 II 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 Principal Investigators. The CRCII will assist with the operational and financial functions of the Clinical and Translational Research.

Daily Operations
  • 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; Responsible for collecting and documentation of monies collected in clinical research. Responsible for managing accounts receivable and accounts payable in clinical research; Assist with reviews, analyzes and negotiates all clinical research budgets and contracts with sponsors under the direction of the Principal Investigator and Associate Director.
  • Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms. Direct the requisition, collection, labeling, storage, or shipment of specimens.
  • Monitor 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. Inform patients or caregivers about study aspects and outcomes to be expected.
  • Assists with preparing IRB submissions, protocol revisions, and renewals as needed, and maintain copies of all IRB communications delegated by the Principal Investigator.
  • Performs other related duties as assigned.

Required Skills
  • Must possess a good working knowledge of basic clinical research practice.
  • 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.

Required Education and Experience
  • Graduated from an accredited discipline specific program and licensed as a registered nurse in the state of Tennessee. 60 months experience in a patient care setting required (clinical research experience preferred).

OR:
  • A Bachelor's degree in a healthcare related field. 60 months experience required including clinical research experience, administering clinical research grants & contacts, IRB and budget management is preferred.

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