Senior Clinical Trials Auditor
Job posting number: #7093058 (Ref:10014979)
Posted: January 28, 2022
Application Deadline: Open Until Filled
About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 6,000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.
Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers that develops and institutes standards of care for cancer treatment.
Performs comprehensive auditing of City of Hope clinical trials to ensure that trials are conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subject safety and data integrity. This position is responsible for planning, coordination, control, and continuous improvement of processes and methods to ensure conformance to internal and external quality standards at City of Hope. This position will be responsible for developing and implementing a detailed audit plan and SOPs to support the COH Audit Program, managing the internal auditing functions and developing training programs, consistent with organizational needs and in accordance with current GCP and federal requirements.
Key Responsibilities include:
- Prepares for internal audit visits and reviews the original protocol and all amendments, noting dates, changes in eligibility criteria, and any modifications in treatment procedures.
- Verifies that required reporting of protocol deviations, unanticipated problems, and Serious Adverse Events (SAE) to internal organizations (IRB, CPRMC, IBC, RSC, DSMC) and external regulatory agencies (FDA) has been completed in a timely manner.
- Audits study data for highly complex Phase I CAR-T and hematology trials at COH, Community Practice Sites and External Subsites, including the consent process, eligibility criteria and case report forms (CRFs), utilizing medical records, laboratory data, pharmacy and transfusion services records, and any other source used to produce study data. Verifies that corrections to the CRFs are made correctly, if applicable.
- Independently generates audit reports, summarizing the findings of all protocol deviations, discrepancies, noncompliance and incorrect or missing data for review by study team and City of Hope Data and Safety Monitoring Committee (DSMC), Institutional Official, COH Disease Teams, and Institutional Audit Committee. When direction is needed, provides guidance for principal investigators, CRCs, and clinical research nurses to correct findings.
- Presents audit visit reports at convened Disease Team meetings and Disease Team meetings.
- Independently coordinate ongoing and upcoming audit assignments (including meeting with PI and study team to present findings from audit reports) and meets expected timelines for completion of monitoring activities and submission of written audit reports.
- May be required to travel to other participating sites up to approximately 15% of the time to perform audits of enrolled subjects as described above.
Program Development and Maintenance
- Develops structure and procedure for various audit types including but not limited to: functional audits, routine audits, audit pool, and for cause audits.
- Creates electronic audit report templates, email communication templates, follow up letter templates, corrective action plan templates, and all other audit related communication templates.
- Under the guidance of the Director for Safety and Data Quality, develops detailed step-by-step work instructions for all audit types and creates standard operating procedures to support the development of the audit program. Develop new and revise existing institutional policies as necessary.
- Liaise with clinical trials office staff, researchers, research protections staff and other research operations staff as necessary to conduct root cause analysis as required following the completion of internal audit.
- Maintain electronic systems for effective receipt, logging, tracking, and management of documents related to the management and auditing of research. Such systems may include iRIS, eReg Binder, shared drive and OnCore as well as the case reporting form system.
- Assists in developing training material and/or delivers training related to audits and inspections.
- Serves as a subject matter expert on research related regulations and keeps current with new GCP, federal and institutional regulatory requirements related clinical research and translates new information into educational sessions for PIs, study teams, and other members of the research community.
- Works closely with Safety & Data Quality team to create research protections staff onboarding, training and education/reeducations plans as needed.
- Collects data on findings and prepare reports and analyses disseminating results of compliance audits with appropriate recommendations. Plan and perform subsequent audits to ensure complete and appropriate corrective action. Participate in team meetings with PIs to discuss study conduct.
- Support investigators and study teams in creating corrective and preventative action plans and reviews appropriateness of plan in response to external audits conducted at COH or participating sites.
- Assist in identification of research operations process gaps or areas of process improvement and find efficient solutions.
Basic education, experience and skills required for consideration:
- Bachelor’s degree in biology, chemistry, biochemistry, physiology, nursing, or other related fields.
- Five or more years of experience as Clinical Research Associate or clinical trial monitor for Oncology and/or Hematology clinical trials.
- Familiar with Investigational New Drug procedures, study protocols, the informed consent process, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and applicable regulatory requirements.
Preferred education experience and Certification/Licensure:
- Master’s degree preferred.
- Experience managing clinical trials.
- Experience as a regulatory affairs administrator.
- Trained and certified as a Clinical Research Associate by the Association of Clinical Research Professionals (ACRP) or as a Clinical Research Professional by the Society of Clinical Research Associates (SoCRA).
- Exceptionally detail oriented
- Ability to efficiently review documents while focusing on specific data
- Research information
- Compile data
- Compose reports, ancillary documentation, and training documents
- Instruct/train others
- Compose letters/memorandums
- Troubleshoot problems
- Excellent oral/written communication and organizational skills
- Foster and promote a positive image and professional appearance.
City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.
City of Hope is a community of people characterized by our diversity of thought, background and approach, but tied together by our commitment to care for and cure those with cancer and other life-threatening diseases. The innovation that our diversity produces in the areas of research, treatment, philanthropy and education has made us national leaders in this fight. Our unique and diverse workforce provides us the ability to understand our patients' needs, deliver compassionate care and continue the quest for a cure for life-threatening diseases. At City of Hope, diversity and inclusion is a core value at the heart of our mission. We strive to create an inclusive workplace environment that engages all of our employees and provides them with opportunities to develop and grow, both personally and professionally. Each day brings an opportunity to strengthen our work, leverage our different perspectives and improve our patients’ experiences by learning from others. Diversity and inclusion is about much more than policies and campaigns. It is an integral part of who we are as an institution, how we operate and how we see our future.