Clinical Auditor Cover Letter

I am excited to be applying for the position of clinical auditor. Please accept this letter and the attached resume as my interest in this position.

Previously, I was responsible for or arranges for training of facility healthcare professionals including physicians in use of coding guidelines and practices, proper documentation techniques, medical technology, and disease processes as it relates to DRG and other clinical data quality management factors.

My experience is an excellent fit for the list of requirements in this job:

• BS or AA in nursing, health sciences, health management or a related clinical field
• Experience working with EMR (electronic medical records) or clinical databases
• Conduct, on a global level, Good Clinical Practice (GCP) audits of clinical studies, suppliers, and documents (such as protocols, Patient Information Sheet/Informed Consent Document, Monitoring) to assess whether all aspects of the clinical investigation and internal processes are in compliance with applicable regulatory requirements and established company procedures
• Participate in GCP System Audit teams by assisting in the development of the audit plans, developing tools for conducting such audits, conducting the audit, and reporting the results
• Contact the local medical department to arrange a presentation of the data, make the presentation and provide general advice on process improvements
• Participate in regulatory authority pre-, during-, and post- inspection activities as needed and requested by GDQ management
• Provide interpretation and guidance for internal and external customers on clinical quality related regulations / guidelines (FDA, ICH, EU, ) and company procedures and policies, proactively maintaining cognizance of current GCP standards
• Support the development and refinement of the Global Quality System by participating in SOP/OI authorship or review teams

In response to your job posting for clinical auditor, I am including this letter and my resume for your review.

Previously, I was responsible for monthly quality reviews of UM nurse determinations in Facets Prospective UM; collaborates with Clinical Trainer to educate nursing staff regarding regulatory compliance and corrects application of Milliman guidelines.

Please consider my experience and qualifications for this position:

• Support the development and refinement of the global quality system by participating in standard operationg procedure / OI review teams
• Conduct training on the audit process and other processes owned by research & development for internal and external customers (eg, to medical development, suppliers, and clinical investigators at investigator meetings)
• Familiarity with medical terminology and routine medical tests and procedures, computerized clinical data collection systems, and biomedical statistics is needed
• Possess strong interpersonal and oral and written communication skills in order to effectively and independently conduct audits and communicate results
• Strongly preferred Nursing education (ASN, BSN, or MSN)
• Knowledge of the law and regulations and it relates to fraud and fraud investigations
• Strong knowledge of the Medicare and Medicaid Programs
• Extensive experience reviewing medical records and claims for quality care assessments

I would like to submit my application for the clinical auditor opening. Please accept this letter and the attached resume.

In my previous role, I was responsible for ongoing quality reviews of BH case manager determinations in the UM tracking system; educate BH staff regarding regulatory compliance and accurate application of Milliman and other required guidelines.

Please consider my qualifications and experience:

• Conduct training on the audit process and other processes owned by GDQ for internal and external customers (e.g., new hires and consultants to Global Development, Clinical Pharmacology, suppliers, and clinical investigators at Investigator Meetings)
• Be familiar with medical terminology and routine medical tests and procedures
• Strong interpersonal and oral and written communication skills in order to effectively and independently conduct audits and communicate results
• Be confident and adept in the use of computerized databases and other applications
• Familiarity with computerized clinical data collection systems and biomedical statistics
• Certified Professional in Healthcare Quality or Certified Professional Coder (CPC) preferred
• Specialty license and experience in Case Management
• Has significant complex level clinical quality, clinical affairs, pre-clinical or biomedical monitoring experience

In response to your job posting for clinical auditor, I am including this letter and my resume for your review.

In the previous role, I was responsible for clinical and operational support for planning, creating, maintaining and reviewing health plan Medicare Part D and Medicare-Medicaid Plan (MMP) Formularies, Prior Authorization (PA) criteria, Step Therapy (ST) Criteria and other utilization management (UM) restrictions.

Please consider my experience and qualifications for this position:

• Certified Professional in Healthcare Quality (CPHQ) or Certified Professional Coder (CPC) preferred
• Experience with Facility Site Reviews and Medical Record Review is preferred
• HEDIS and audit experience is preferred
• Conduct, on a regional level, good clinical practice audits of clinical studies, suppliers, and documents (such as protocols, informed consent, monitoring plans)
• Assess whether all aspects of the clinical investigation and internal processes are in compliance with applicable regulatory requirements and established company procedures
• Participate in periodic compliance metrics trending to identify problem areas in clinical drug development
• Participate in regulatory authority pre-, during-, and postinspection activities as needed and requested by research & development management (eg,working alongside a Senior Global clinical auditor as an inspection committee member, providing basic advice on preparations for inspections, assisting in the conduct of preinspection audits, and/or serving other roles as defined by the inspection committee or rdq committee representative) to promote the successful outcome of the inspection
• Provide interpretation and guidance for internal and external customers on clinical quality related regulations / guidelines (Food & Drug Administration, Internal Council for Harmonisation, ) And company procedures and policies, proactively maintaining cognizance of current good clinical practice standards

In response to your job posting for clinical auditor, I am including this letter and my resume for your review.

Previously, I was responsible for training/education of medical record reviews to staff to enhance clinical knowledge and integrity within the program.

My experience is an excellent fit for the list of requirements in this job:

• Conduct, on a global level, Good Clinical Practice audits of clinical studies, suppliers, and documents (such as protocols, Patient Information Sheet/Informed Consent Document, Monitoring) to assess whether all aspects of the clinical investigation and internal processes are in compliance with applicable regulatory requirements and established company procedures
• Participate in Good Clinical Practice System Audit teams by assisting in the development of the audit plans, developing tools for conducting such audits, conducting the audit, and reporting the results
• Contacts the local medical department to arrange a presentation of the data, makes the presentation and provides general advice on process improvements
• Participate in regulatory authority pre-, during-, and post-inspection activities as needed and requested by Global Development Quality management
• Provide interpretation and guidance for internal and external customers on clinical quality related regulations / guidelines (Food & Drug Adminstration, Inernational Council for Harmonisation, EU, ) and company procedures and policies, proactively maintaining cognizance of current Good Clinical Practice standards
• Support the development and refinement of the Global Quality System by participating in Standard Operating Procedure /OI authorship or review teams
• Conduct training on the audit process and other processes owned by Global Development Quality for internal and external customers (e.g., new hires and consultants to Global Development, Clinical Pharmacology, suppliers, and clinical investigators at Investigator Meetings)
• Current NYS licensed NP, LPN or RN