Senior Compliance Officer
Senior Compliance Officer
Posted on :
26-06-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
26-06-2025
Job Description
Job Summary
The Clinical Site Auditor reviews HCI Investigator Initiated Trials (IITs) for accuracy internal consistency and compliance with applicable regulations and GCP guidelines. The auditor is a member of the Research Compliance Office ( RCO ) and conducts an initial audit approximately one year after enrollment begins and annually thereafter for IITs of all risk levels. In general audits are conducted to verify the effectiveness of monitoring including review of subject eligibility informed consent disease outcome AEs and toxicity data quality regulatory documentation investigational drug records and compliance with institutional procedures and applicable regulations and guidelines. The auditor reviews previous audit reports and monitoring letters to verify correction of issues/findings or to discover any recurring issues or negative trends that may exist. Study subject records or research charts are audited to ensure the authenticity of study conduct and validity of study results. Audits of HCI IITs are performed independent of study monitoring. Certified Clinical Research Professional ( CCRP CCRC or CCRA ) and prior experience or knowledge of oncology and oncology related research is essential. The individual should have proven leadership and job performance with ability to manage increasingly complex tasks. The Senior Auditor will perform those functions of Clinical Site Auditor and will act as a mentor to junior RCO staff. The Senior Auditor will assist the manager in evaluating workload creating and implementing process improvements and other training needs within the department and institution. Huntsman Cancer Institute is committed to cancer prevention care and survivorship for all communities within the area we serve which includes Idaho Montana Nevada Utah and Wyoming with impact worldwide. In your cover letter or during your interview process we invite you to share how your professional experiences have prepared you to serve as a member of our team as we work to reduce the cancer burden experienced by all people and communities. This may include description of your prior experiences related to research prevention clinical care community engagement/outreach training administration or other areas relevant to Huntsman Cancer Institutes mission and this position.
Responsibilities
Disclaimer This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties responsibilities and qualifications required of employees assigned to the job. Essential Functions Oversee coordinate and conduct routine audits on cancer related investigator-initiated clinical trials in accordance with the National Cancer Institute approved Data and Safety Monitoring Plan to ensure compliance with study protocol University state and federal guidelines. Compile comprehensive reports for Principal Investigators the Data and Safety Monitoring Committee ( DSMC ) and other committees as assigned. Meet with PI and study team to discuss audit findings and resolutions. Analyze and document audit process results and outcome. Report outcomes to the DSMC . Determine the validity of collected data assessing process shortfalls and developing effective safeguards to reduce risk in clinical research. Recommend corrections to audit findings and enhancements to operating policies and procedures as well as study protocols. Develop departmental SOPs. Serve as the primary contact and expert regarding regulatory agency standards governing clinical trials. Conduct quality assurance reviews on non- IIT cancer related clinical trials to ensure compliance with study protocol university state and federal guidelines. Develop coordinate and participate in educational and training programs to enhance compliance and awareness of compliance issues. Assist with training and onboarding of new RCO staff. Act as a mentor to junior level staff. Assist manager to evaluate and prioritize workload within the team. Conduct training and continuing education events within the RCO and CTO Assist in addressing complicated questions within the team. May work with groups outside of the Clinical Trials Office for example Population Sciences to conduct audits to ensure compliance in their research Work with PI and study team to ensure compliance with the protocol GCPs applicable regulations and SOPs in order to protect the rights safety and well-being of research participants and to protect the integrity of study data. Maintain current knowledge regarding federal and state guidance including Good Clinical Practice ( GCP ). Problem Solving Incumbent is responsible for assisting the University in preparation for regulatory audits by developing monitoring and updating quality controls and recommending actions to maintain compliance. This position is the primary contact and expert regarding regulatory agency standards governing clinical trials. Representative challenges of this position include determining the validity of collected data assessing process shortfalls and developing effective safeguards to reduce risk. The incumbent must possess the ability to foster collaborative working relationships with a wide range of constituencies as well as the RCO team. Work Environment and Level of Frequency typically required Nearly Continuously: Office environment. Physical Requirements and Level of Frequency that may be required Nearly Continuously: Sitting hearing listening talking. Often: Repetitive hand motion (such as typing) walking. Seldom: Bending reaching overhead.
Minimum Qualifications
Bachelors Degree in Health Care Administration Business Administration or a related field or equivalency (one year of education can be substituted for two years of related work experience); plus seven years working experience with at least four of those years in a compliance office or the equivalent; the American Health Information Management ( AHIMA ) or American Academy of Professional Coders ( AAPC ) recognized coding certification ( CPC CPC -H ACS CCS -P/H RHIA ); knowledge of medical auditing Federal healthcare program policies and requirements (including Medicare Parts A and B) and ICD -10 CPT HCPCS DRG coding; proficient with word processing spreadsheet and related computer applications; demonstrated human relations and effective communication skills also required. Masters Degree in a related field is preferred. Certification from the Healthcare Compliance Association ( HCCA ) as a Compliance Officer is preferred. This position is not responsible for providing patient care.
The Clinical Site Auditor reviews HCI Investigator Initiated Trials (IITs) for accuracy internal consistency and compliance with applicable regulations and GCP guidelines. The auditor is a member of the Research Compliance Office ( RCO ) and conducts an initial audit approximately one year after enrollment begins and annually thereafter for IITs of all risk levels. In general audits are conducted to verify the effectiveness of monitoring including review of subject eligibility informed consent disease outcome AEs and toxicity data quality regulatory documentation investigational drug records and compliance with institutional procedures and applicable regulations and guidelines. The auditor reviews previous audit reports and monitoring letters to verify correction of issues/findings or to discover any recurring issues or negative trends that may exist. Study subject records or research charts are audited to ensure the authenticity of study conduct and validity of study results. Audits of HCI IITs are performed independent of study monitoring. Certified Clinical Research Professional ( CCRP CCRC or CCRA ) and prior experience or knowledge of oncology and oncology related research is essential. The individual should have proven leadership and job performance with ability to manage increasingly complex tasks. The Senior Auditor will perform those functions of Clinical Site Auditor and will act as a mentor to junior RCO staff. The Senior Auditor will assist the manager in evaluating workload creating and implementing process improvements and other training needs within the department and institution. Huntsman Cancer Institute is committed to cancer prevention care and survivorship for all communities within the area we serve which includes Idaho Montana Nevada Utah and Wyoming with impact worldwide. In your cover letter or during your interview process we invite you to share how your professional experiences have prepared you to serve as a member of our team as we work to reduce the cancer burden experienced by all people and communities. This may include description of your prior experiences related to research prevention clinical care community engagement/outreach training administration or other areas relevant to Huntsman Cancer Institutes mission and this position.
Responsibilities
Disclaimer This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties responsibilities and qualifications required of employees assigned to the job. Essential Functions Oversee coordinate and conduct routine audits on cancer related investigator-initiated clinical trials in accordance with the National Cancer Institute approved Data and Safety Monitoring Plan to ensure compliance with study protocol University state and federal guidelines. Compile comprehensive reports for Principal Investigators the Data and Safety Monitoring Committee ( DSMC ) and other committees as assigned. Meet with PI and study team to discuss audit findings and resolutions. Analyze and document audit process results and outcome. Report outcomes to the DSMC . Determine the validity of collected data assessing process shortfalls and developing effective safeguards to reduce risk in clinical research. Recommend corrections to audit findings and enhancements to operating policies and procedures as well as study protocols. Develop departmental SOPs. Serve as the primary contact and expert regarding regulatory agency standards governing clinical trials. Conduct quality assurance reviews on non- IIT cancer related clinical trials to ensure compliance with study protocol university state and federal guidelines. Develop coordinate and participate in educational and training programs to enhance compliance and awareness of compliance issues. Assist with training and onboarding of new RCO staff. Act as a mentor to junior level staff. Assist manager to evaluate and prioritize workload within the team. Conduct training and continuing education events within the RCO and CTO Assist in addressing complicated questions within the team. May work with groups outside of the Clinical Trials Office for example Population Sciences to conduct audits to ensure compliance in their research Work with PI and study team to ensure compliance with the protocol GCPs applicable regulations and SOPs in order to protect the rights safety and well-being of research participants and to protect the integrity of study data. Maintain current knowledge regarding federal and state guidance including Good Clinical Practice ( GCP ). Problem Solving Incumbent is responsible for assisting the University in preparation for regulatory audits by developing monitoring and updating quality controls and recommending actions to maintain compliance. This position is the primary contact and expert regarding regulatory agency standards governing clinical trials. Representative challenges of this position include determining the validity of collected data assessing process shortfalls and developing effective safeguards to reduce risk. The incumbent must possess the ability to foster collaborative working relationships with a wide range of constituencies as well as the RCO team. Work Environment and Level of Frequency typically required Nearly Continuously: Office environment. Physical Requirements and Level of Frequency that may be required Nearly Continuously: Sitting hearing listening talking. Often: Repetitive hand motion (such as typing) walking. Seldom: Bending reaching overhead.
Minimum Qualifications
Bachelors Degree in Health Care Administration Business Administration or a related field or equivalency (one year of education can be substituted for two years of related work experience); plus seven years working experience with at least four of those years in a compliance office or the equivalent; the American Health Information Management ( AHIMA ) or American Academy of Professional Coders ( AAPC ) recognized coding certification ( CPC CPC -H ACS CCS -P/H RHIA ); knowledge of medical auditing Federal healthcare program policies and requirements (including Medicare Parts A and B) and ICD -10 CPT HCPCS DRG coding; proficient with word processing spreadsheet and related computer applications; demonstrated human relations and effective communication skills also required. Masters Degree in a related field is preferred. Certification from the Healthcare Compliance Association ( HCCA ) as a Compliance Officer is preferred. This position is not responsible for providing patient care.
Required Experience:
Senior IC
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
