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Clinical Research Associate II

Duke Clinical Research Institute

Durham, North Carolina
  • Clinical Operations
Duke Clinical Research Institute
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  • Research Salary

Job Details

Oversee and review routine and moderately complex site activities, with minimal to no guidance, through monitoring activities, including on-site visits and/or in-house assessments, including telephone contact, and other technologies according to the trial-specific monitoring plan to assess protocol, regulatory, and SOP compliance with some guidance from an experienced CRA or a clinical trial lead.

  • May travel up to 80% to perform on-site monitoring visits, including site selection, initiation, periodic, and close out visits. Perform or assist with unexpected site visits as directed. Schedule site visits according to DCRI travel policy and trial-specific guidelines while effectively using cost and time saving efficiencies.
  • b. Independently perform monitoring activities for multiple sites and possibly multiple projects, identifying and reporting deviations from regulations and SOPs. Assess protocol and regulatory compliance, including but not limited to source document verification, informed consent process and human subject protection, data integrity, drug accountability and compliance, and review of investigator and regulatory files.
  • c. Assess adequacy of site personnel and facilities for study conduct.
  • d. Provide study training and guidance to designated site personnel for conducting studies in accordance with the protocol, SOPs, trial specific procedures and applicable regulations. Identify situations that may affect subject safety or data integrity and retrain site personnel accordingly.
  • e. Identify action items and discuss with appropriate site personnel. Communicate routine and unusual findings to trial supervisor. Document ongoing follow-up and resolution of issues. Recognize ongoing action items and coach site personnel to improve their performance.
  • f. Assist sites with preparation for planned and unannounced audits with some guidance.
  • g. Perform trial supervisory activities as directed by trial project leader with approval of line manager.

Independently document routine site management and clinical monitoring activities, site communication, and trial related activities. Document complex site management and clinical monitoring activities, site communication, and trial related activities with minimal to no guidance. Utilize monitoring tools and trial documents, recommend revisions to improve efficiencies of monitoring tools, trial documents, and study processes; independently develop study-specific versions as directed.

a. Apply knowledge of protocol and study documents and processes, during monitoring activities, including on-site visits and in-house assessments, in response to site activities and inquiries.

b. Regularly review and update study and site status information into required systems to maintain accurate, current reports.

c. Independently prepare monitoring reports for multiple sites and projects with no more than 3% spelling and grammatical errors. Prepare and submit accurate and timely confirmation letters, monitoring reports, follow-up letters and expense reports, using standard templates and forms, in accordance with SOPs and project requirements. Assist trial supervisor with review of monitoring visit documentation for other team members.

d. Maintain essential trial and site communication records, electronic and hard copy, removing non-essential communication to meet trial and organizational and government standards as directed.

e. Develop and implement action plans for resolution of routine and complex site and study issues. Follow up on outstanding issues including ongoing documentation

  • Manage and review routing and moderately complex site data including case report form (CRF) completion and submission, data query resolution, and overall data integrity according to established practices, with minimal to no guidance. Recommend improvements for data collection and data processing and implement efficiencies as directed.
  • Build and maintain effective working relationships with site personnel, internal and external study contacts. Promote confidence in the Clinical Operations functional group and the DCRI.
  • Provide routine updates and moderately complex reports to trial supervisor(s) and other assigned contacts to ensure timely communication regarding status of sites, study issues and resolutions, and trial activities with minimal to no guidance.
  • 6. Serve as a resource to other team members for day-to-day trial activities. Participate as a trainer and mentor for subordinates, peers, and site personnel.
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