PRIM&R accepts advertisements from all institutions seeking to hire for positions in animal and human research ethics and related fields, such as research administration and ethics education; listing does not imply endorsement of the lister or of the qualifications stated for a position.
Reporting to the Senior Manager of Internal Audit and to the Human Research Protection Program (HRPP) Director at Connecticut Children’s Medical Center, the Senior Clinical Research Auditor designs and executes an annual research auditing and monitoring plan to promote prevention, detection, and resolution of research non-compliance. The Senior Clinical Research Auditor also conducts compliance reviews, including study initiation reviews and post approval monitoring. At the request of the Institutional Review Board, the Senior Clinical Research Auditor provides consent process training and observation and conducts investigations of allegations of noncompliance.
The Senior Clinical Research Auditor collaborates with the HRPP management, the Department of Research, the Clinical Trials Unit, and the Office of Grants and Sponsored Programs to evaluate the effectiveness of current internal controls; validates compliance with state and federal regulations, IRB protocol, and HRPP Standard Operating Procedures; and recommends process, procedure, and policy improvements to mitigate against identified risks. This position is responsible for identifying potential IRB, HRPP, general research, and clinical trial non-compliance, researching appropriate guidelines to support recommended improvements, and communicating these improvements on a timely basis. The Senior Clinical Research Auditor provides expert advice and education to research personnel, clinical staff and physicians.
Identifies and evaluates studies for compliance adherence (including HRPP post approval monitoring) and applies risk based approach to the selection of studies.
Coordinates with senior leadership to design and propose an annual risk based research and clinical trial audit plan.
Defines the risk-based annual clinical research audit plan as well as designs and executes individual audit programs, test work, and reporting in order to promote prevention, detection, and resolution of clinical research non-compliance.
Conducts monitoring of protocols in which IRB reliance agreements are invoked to ensure compliance with institutional policies and federal and state regulations
Executes clinical trial billing and payment audits of medical records and associated clinical documentation to ensure proper charge capture and billing in accordance with standard state, federal, sponsor allowances, and internal reimbursement policies, principles, and mandates.
Advises on best practice processes and procedures to ensure compliance with all state and federal regulatory requirements, Good Clinical Practice (GCP) guidelines, Institutional Review Board (IRB)-approved research protocol, and Human Research Protection Program (HRPP) Standard Operating Procedures, and the accreditation standards for the Association for the Accreditation of Human Research Protection Programs (AAHRPP)
At the request of the Institutional Review Board, investigates internal or external allegations of non-compliance.
Maintains up-to-date knowledge of research compliance guidelines so as to ensure entity-wide consistent application and execution of regulatory guidelines.
Identifies deficiencies and recommends risk mitigating recommendations to improve processes, strengthen controls, and reduce occurrences of non-compliance.
Collaborates with Principal Investigators and Research Teams on audit findings, corrective and preventive action plans.
Prepares written reports and trending data related to findings and facilitates sign off with leadership
Works with audit management to confirm management action plans were executed and have mitigated the identified risk effectively.
Maintains an open dialogue and good working relationship with internal and external personnel in order to advance entity objectives and goals.
Performs other general compliance related audits as requested.
Demonstrates cultural sensitivity in all interactions with patients/families and co-workers.
Demonstrates support for the mission, values and goals of the organization through behaviors that are consistent with the Connecticut Children's standards.
EDUCATION AND TRAINING RESPONSIBILITIES
Educates senior leaders, principal investigators, and study personnel on and compliance with regulations, including principles of Good Clinical Practice (where applicable), policies and procedures.
Educates principal investigators on the responsibilities of serving as the Sponsor-Investigator on Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications and provides ongoing study monitoring for Sponsor-Investigator IND/IDE studies
Develops, maintains, and disseminates educational tools and trainings aimed to facilitate compliant research practices in accordance with institutional policies
Provides individual trainings and group presentations aimed to educate the research community (e.g., New PI orientation and Research Coordinator Orientation) and keep practices current with new regulations, policies and practices.
Conducts study initiation meetings to ensure correct understanding of the IRB approved application, consent form, and HIPAA authorization form (where applicable), study protocol, study procedures, study start-up materials, roles and responsibilities of each study staff member, identifies the regulations and policies pertinent to each study, and provides materials and tools to facilitate adherence for new studies.
EDUCATION and/or EXPERIENCE REQUIRED
A Bachelor’s degree in a scientific or health care field with at least 5 years of clinical research experience.
Advanced understanding, interpretation, and application of federal and state regulations governing human subject research ((HHS 45 CFR 46; FDA 21 CFR parts 50, 54, 312 and 812), HIPAA, and good clinical practices (ICH -GCP)), financial compliance and research billing quality standards and relevant systems experience
Prior experience as clinical research monitor/associate (CRA) for FDA and Physician Initiated regulated trials a plus.
3-5 years’ experience in a clinical research setting, preferably in a clinical research supervisory role and additional experience
LICENSE and/or CERTIFICATION
Certified in Healthcare Research Compliance (CHRC) preferred
KNOWLEDGE AND ABILITIES REQUIRED
Federal and state regulations governing (1) human subject research, (2) financial compliance and research billing
Research regulations regarding human subject protections
Sponsor-investigator responsibilities for IND and IDE-holders, and applicable FDA regulations
Clinical investigations, - the biotech/pharmaceutical industry, and social and behavioral science research
Experience working in a Teaching Hospital setting preferred.
Prior experience with billing and claims processing preferred.
Prior experience working in a hospital or clinical setting is preferred.
Communication Skills: The ability to develop, facilitate, and orchestrate effective communication with all levels of staff including clinical staff (investigators, nurses, etc.), administration, research and clerical support staff, and Institutional Leaders as well as external sponsors.
Analytical Skills: A strong ability and understanding on how to collect, analyze, interpret and prepare data for presentation (i.e., written, tabular and graphical formats). Excellent problem-solving ability.
Ability to analyze situations, draw conclusions, make recommendations and convey information in a timely and proficient manner. Strategic thinker.
Time Management Skills: The ability to set priorities among several tasks simultaneously and meet established deadlines.
Administrative Skills: The ability to plan, organize, facilitate and lead meetings, to develop programs, to manage research projects and to prioritize work across several services/departments is essential.
Creativity in developing and initiating new quality improvement initiatives
Internal Number: Req # 8341
About Connecticut Children's Medical Center
Connecticut Children's Medical Center
Hartford, CT 06106