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Clinical Research Lead Auditor/Monitor (Oncology Studies) Remote

2+ years
$85,000 to $95,000 per year
10 Nov. 14, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Lead Auditor – Clinical Trials & Oncology Research

The Lead Auditor is responsible for overseeing the EA Audit process, leading the audit team to ensure compliance with protocol, regulatory, pharmacy, and data collection requirements. This role includes reviewing Clinical Trials Management Branch (CTMB) guidelines and EA audit policies to ensure accuracy and compliance in clinical trials. Audits can be performed on-site or remotely based on the audit plan. The Lead Auditor writes reports detailing audit findings, recommends corrective actions as necessary, and submits findings to the NCI. The role also involves preparing documentation, providing education, and supporting both internal and external inquiries regarding the audit program.

This position is remote with up to 20% travel for meetings and site audits.

Job Requirements:

Experience:

  • Minimum of two (2) years of experience auditing patient charts
  • Minimum of five (5) years of experience in clinical research or oncology data management
  • Experience with NCTN clinical trial operations, data management, audit, and quality assurance

Education:

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

Responsibilities:

  • Manage the audit process for EA sites, including site and date selection
  • Ensure audits follow CTMB guidelines and relevant EA and FDA policies
  • Participate in teleconferences, webinars, and on-site audits nationwide
  • Prepare audit materials and reports, including electronic and hard copies
  • Assign tasks to audit team members and assist in the recruitment of volunteer auditors
  • Provide training to volunteer auditors and EA staff
  • Conduct timely audits, track requested data/documents, and ensure compliance with GCP, OHRP, and FDA regulations
  • Perform source data verification in Medidata RAVE and resolve compliance queries
  • Coordinate internal/external meetings and revise SOPs as needed
  • Maintain audit documentation and manage the circulation of reports
  • Develop educational materials to help sites maintain audit readiness
  • Provide training at semi-annual meetings and targeted webinars

About ECOG-ACRIN MRF: ECOG-ACRIN Cancer Research Group is a multidisciplinary organization conducting biomarker-driven cancer clinical trials for adults at risk of or diagnosed with cancer. Based in Philadelphia, PA, with additional centers in Boston, MA, ECOG-ACRIN is a project of the ECOG-ACRIN Medical Research Foundation.