3 Lead Auditor, Audit and QC+ Jobs in Philadelphia, PA
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Lead Auditor, Audit and QC+
$85k-102k (estimate)
Other | Business Services
8 Months Ago
System One is Hiring a Lead Auditor, Audit and QC+ Near Philadelphia, PA
Job Title: Lead Auditor, Audit and Quality Control Type: Direct Hire/Permanent Schedule: Hybrid 2-3 days onsite in Philadelphia
Experience
• Must have experience in GCP auditing for clinical trials.
• 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, 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 sites, including audit site and date selection • Ensures audits are conducted according to the current CTMB Guidelines and relevant 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 the recruitment of volunteer auditors (MDs and CRAs) • Provides training for volunteer CRA auditors, volunteer MD auditors, and other supportive staff as instructed. • Conducts audits in a timely fashion. • Follow through and tracking of any additional requested data/documents from 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 sites. Includes documents designed to help sites maintain audit readiness. • Provides training to sites at semi-annual meetings and targeted webinars as instructed.
Experience
• Must have experience in GCP auditing for clinical trials.
• 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, 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 sites, including audit site and date selection • Ensures audits are conducted according to the current CTMB Guidelines and relevant 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 the recruitment of volunteer auditors (MDs and CRAs) • Provides training for volunteer CRA auditors, volunteer MD auditors, and other supportive staff as instructed. • Conducts audits in a timely fashion. • Follow through and tracking of any additional requested data/documents from 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 sites. Includes documents designed to help sites maintain audit readiness. • Provides training to sites at semi-annual meetings and targeted webinars as instructed.
Job Summary
JOB TYPE
Other
INDUSTRY
Business Services
SALARY
$85k-102k (estimate)
POST DATE
10/07/2023
EXPIRATION DATE
07/09/2024
WEBSITE
healthsystemone.com
HEADQUARTERS
MIAMI, FL
SIZE
25 - 50
TYPE
Private
CEO
JOSEPH BRUCE
REVENUE
$10M - $50M
INDUSTRY
Business Services
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