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Clinical Research Coordinator Nurse II

Meharry Medical College

Nashville, Tennessee

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JOB DETAILS
SKILLS
Accounting, Accounts Payable, Accounts Receivable Management, Analysis Skills, Billing, Budgeting, Calendar Management, Case Report Form (CRF), Clinical Assessment, Clinical Nursing, Clinical Research, Clinical Trial Management, Computer Skills, Electrocardiogram, FDA (Food and Drug Administration), Federal Laws and Regulations, Financial Analysis, GCP (Good Clinical Practices), HIPAA (Health Insurance Portability and Accountability Act), Healthcare Quality, ICH Regulations, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Interviewing Skills, Maintain Compliance, Medical Records, National Institutes of Health (NIH), Negotiation Skills, Nursing, Operations, Organizational Skills, PC (Personal Computer) Systems, Patient Care, Record Keeping, Registered Nurse (RN), Regulations, Research Contracts, Research Nursing, Research Protocols, Specimen Collection, Standard Operating Procedures (SOP), State Laws and Regulations, Translational Research, Willing to Travel
LOCATION
Nashville, Tennessee
POSTED
6 days 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 Principal Investigators. The CRCII will assist with the operational and financial functions of the Center of Excellence for 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 and travel to participant's location for recruitment activities
  • 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/ Associate Director
  • Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms. Direct the requisition, collection, Processing of samples, 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 (Experience as a travel nurse or clinical research experience preferred).

About the Company

M

Meharry Medical College

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