Provides technical and guidance on all aspects of research regulatory affairs including those relating to the International Conference on Harmonization (ICH) guidelines for Good Clinical Practice (GCP), Food and Drug Administration (FDA), National Institutes of Health (NIH), Association for the Accreditation of Human Research Protection Programs (AAHRPP), research sponsors, and MCHS institutional guidelines. Provides assistance to MCHS investigators (physicians, nurses, residents & fellows) as they navigate the regulatory environment. Collaborates with the Clinical Trials Operations team, Research Billing and Contracts team, Research Analytics and Data team, the Sponsored Programs team, and other clinical research professionals to ensure clinical research and related activities are performed in accordance with all applicable federal regulations and MCHS and sponsor policies and procedures.Knowledge/Skills/Abilities:Masters, Doctorate, or other degree preferred.Healthcare or research compliance certification preferred.Knowledge of International Conference on Harmonization (ICH) guidelines for Good Clinical Practice (GCP) required.Knowledge of MCHS institutional guidelines for research.Familiar with clinical research practices and procedures.Strong organizational, planning, and follow-up skills.Ability to hold others accountable.Ability to transfer technical knowledge to others using a variety of tools and techniques.Ability to relate cooperatively and constructively with coworkers, potential/actual investigators, and research staff.Ability to communicate effectively both verbally and in writing.Ability to maintain confidentiality of sensitive information.Ability to set and effectively communicate priorities in a changing environment.Ability to respond calmly under stressful conditions.Ability to use logical and scientific thinking to interpret technical data and solve a broad range of problems.ESSENTIAL JOB DUTIES:Manages and sets priorities for the conduct of Regulatory Affairs staff activities.Manages and actively participates in the day-to-day Regulatory Affairs activities including communications with the IRB, investigators, Sponsors, and internal partners.Provides technical guidance and training to Regulatory Affairs staff during submission preparation and development of informed consent/assent documentation. Provides training on departmental policies and procedures, new FDA guidance documents, FDA warning letters, and regulatory compliance updates.Responsible for reviewing protocols and reports generated by Regulatory Staff to support regulatory compliance and submissions.Builds partnerships and mutual respect with regulatory authorities (e.g., FDA, DEA, and NIH), Sponsors, and CROs.Ensures Regulatory Staff meet quality goals including correctness, accuracy, timeliness of documentation completion, and/or submission are achieved.Manages and ensures MCHS and MCRI policies and SOPs are harmonized with relevant rules, regulations, quality standards, and good clinical practices.Monitors the external research environment and coordinates the translation of new legislation and regulatory requirements into practice at MCHS.Serves as a resource and as a technical expert for the development and delivery of research-related training for MCHS staff.Responsible for staff related activities including hiring/termination, coaching, orienting, training, and payroll processing. Monitors staff attendance, productivity, and performance markers. Provides counseling to staff, on-going training for new/existing staff on various department tasks, procedures, and systems.Identifies training requirements and establishes research training and education curricula to meet regulatory requirements for investigators, research staff, and trainees.Serves on the Research Leadership team and Education Steering Committee. Participates on teams, committees, and special projects both internal and external to the organization to improve the Research and Hospital operations and processes in order to meet MCHS goals.Manages the regulatory staff in collection, maintenance, and reporting regulatory and training matters as required. Assist the Director in the development and evaluation of Research goals/objectives and that they align with the MCHS strategic initiatives. Manages the activities to support the implementation of objectives.
Bachelor degree in Nursing, Sciences, or other relevant field.Clinical research certification (e.g., CCRC, CCRP, and/or CCRA) required. Five years of experience in clinical research.Extensive experience with clinical trials involving drug and medical device regulations and submissions.Prior work experience with of rules and regulations governing research including the International Conference on Harmonization (ICH) guidelines for Good Clinical Practice (GCP), Food and Drug Administration (FDA), National Institutes of Health (NIH), Association for the Accreditation of Human Research Protection Programs (AAHRPP), and industry sponsors.