Clinical Research Coordinator II/ Study Coordinator

Meharry Medical College

  • Nashville, TN
  • Permanent
  • Full-time
  • 2 months ago
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 Director of CTRC and Medical Director.
  • 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.
  • 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.
  • 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 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).

Meharry Medical College