Clinical Research Lead Auditor/Monitor

3 weeks ago

Philadelphia, United States ECOG-ACRIN MRF Full time
Job DescriptionJob Description

The Lead Auditor’s primary responsibility is the management of the EA Audit process. This position leads the effort of the EA audit team to ensure EA institutions compliance with protocol, regulatory, pharmacy and data collection requirements. Lead Auditors conduct reviews to ensure compliance and procedural accuracy with Clinical Trials Management Branch (CTMB) guidelines and EA audit policy. Auditors could complete their audit reviews on-site or off site depending on the site specific audit plan. Auditors write reports of their findings, including recommendations for corrective actions as needed, which are submitted to the NCI. Auditors also prepare documentation, provide education, and assist with internal and external inquiries about EA’s audit program

Position will work a hybrid schedule out of our Philadelphia office. Some travel is required.

JOB REQUIREMENTS

Experience

  • A minimum of two (2) years of experience auditing patient charts
  • A minimum of five (5) years of experience in clinical research and/or in oncology data management
  • Experience with NCTN clinical trial operations is required
  • Experience with data management, audit, and quality assurance is preferred.

Education

  • Bachelor's degree from an accredited college or university or relevant professional experience is required.
  • Certified Clinical Research Professional (CCRP) certification is strongly preferred.

Responsibilities

  • Coordination of the audit process for EA sites including audit site and date selection
  • Ensures audits are conducted according to the current CTMB Guidelines and relevant EA and FDA policies and work practices.
  • Participation in teleconferences, webinars, visitation of EA sites nationwide, preparation of reports, electronic and hard copy updating and maintenance of site files.
  • Team selection and task assignments for audits.
  • Preparation of audit materials.
  • Assist in recruitment of volunteer auditors (MDs and CRAs)
  • Provides training for volunteer CRA auditors, volunteer MD auditors and other EA supportive staff as instructed.
  • Conducts audits in a timely fashion.
  • Follow through and tracking of any additional requested data/documents from EA sites.
  • Writes all audit report documents as required per CTMB guidelines.
  • Review audit findings for compliance per GCP, OHRP and FDA regulations.
  • Works with internal staff and sites to ensure a smooth audit process.
  • Perform targeted source data verification in Medidata RAVE, review select source documentation remotely for compliance with protocol guidelines, issue/resolve queries where indicated.
  • Coordinate the internal/external meetings and revise SOPs and work practices as instructed.
  • Maintain all audit source docs, circulation/routing of reports.
  • Active role in the creation of educational material for EA sites. Includes documents designed to help sites maintain audit readiness
  • Provides training to sites at EA semi-annual meetings and targeted webinars as instructed.

 

Company DescriptionThe ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) is a multidisciplinary, membership-based scientific organization that designs and conducts biomarker-driven cancer research clinical trials involving adults who have or are at risk of developing cancer. ECOG-ACRIN consists of a headquarters location in Philadelphia, PA., and several fully staffed centers and offices, including an operations office and statistical data management center located in Boston, MA. The ECOG-ACRIN Cancer Research Group is a project of the ECOG-ACRIN Medical Research FoundationCompany DescriptionThe ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) is a multidisciplinary, membership-based scientific organization that designs and conducts biomarker-driven cancer research clinical trials involving adults who have or are at risk of developing cancer. ECOG-ACRIN consists of a headquarters location in Philadelphia, PA., and several fully staffed centers and offices, including an operations office and statistical data management center located in Boston, MA. The ECOG-ACRIN Cancer Research Group is a project of the ECOG-ACRIN Medical Research Foundation

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