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Clinical Research Coordinator

Provision Healthcare Franklin, TN
  • Expired: over a month ago. Applications are no longer accepted.

We are looking for a Clinical Research Coordinator who will be responsible for actively managing clinical trials as assigned. This includes, but is not limited to, reviewing IRB submissions for completeness and accuracy, assisting the regulatory specialist during high volume times, data management as directed by clinical research manager and coordinating correlative or supportive clinical trials, as well as, treatment trials.

JOB RESPONSIBILITIES:

  • Participate in the implementation and management of clinical trials including but not limited to pre-site visits, IRB submission, principal investigator communication, site initiation visits, patient screening, accrual and follow-up, informed consents, monitor visits, case report form submissions, and reporting of severe adverse events
  • Assure adherence to SOPs, good clinical practice, and FDA regulations
  • Work closely with Regulatory Coordinator to ensure all IRB required submissions are submitted according to regulations
  • Record accurate and timely data onto case report forms according to protocol/sponsor requirements
  • Plan and implement pre-study activities on assigned trials by developing timelines for conducting and completing the clinical protocol
  • Obtain informed consent, randomize patient according to protocol, schedule patient visits/tests and assess/document toxicities and adverse effects
  • Assess patient compliance with study procedures and report any deviations to Lead Clinical Care Coordinator and sponsor
  • Document protocol deviations and SAE’s, and resolve protocol queries as assigned
  • Obtain pathology specimens and/or correlative blood draws and process and ship according to protocol requirement
  • Dispense investigational product and maintain accountability logs
  • Participate in the development and management of quality assurance and performance improvement activities within the program

JOB SPECIFICATIONS:

  • Graduate of an accredited community college with an Associates degree, required
  • Graduate of a college or university with a Bachelors degree of science, preferred
  • Active ACRP or SoCRA certification, or seeking certification required
  • Experience in clinical research (oncology preferred)
  • Possess excellent written and oral communication skills, as well as mathematical skills including arithmetic and algebra
  • Demonstrate general computer proficiency, report generation, form design and document editing abilities, including Microsoft applications
  • Ability to gather, organize, and verify data for projects, as well as ability to multi-task and prioritize accordingly
  • Understand basic knowledge of pathophysiology and psychopathology as relates to oncology and other disease processes

Provision Healthcare

Provision Healthcare, LLC, was formed in 2005 with the purpose of developing innovative healthcare solutions focused on improving patient care and clinical outcomes and developing support for research, educational, and charitable causes. Provision has developed a unique, comprehensive expertise in proton therapy that distinguishes us from other equipment suppliers and proton and cancer center developers and operators that have a much narrower focus. The combination of our unique expertise and innovative, entrepreneurial approach continues to propel Provision towards a position of industry leadership with respect to both cancer care and proton therapy

Address

Franklin, TN
Franklin, TN
USA