Coordinates the training and compliance processes of clinical research conducted in CRS and throughout NCH. Develops and implements a variety of clinical research topics as well as quality assurance audits to enhance compliance with regulations.
Develops and implements clinical research education training both within the CRS research unit and throughout the NCH campus; including but not limited to Clinical Research Competency Program, Onboarding and Lab IATA (Category B). Works with CRS leadership to establish and maintain a consistent on-boarding/orientation process for all new hires; continuously evaluates the effectiveness of the onboarding program and makes changes as needed to ensure compliance at all stages.
Provides guidance on Federal Regulations, Good Clinical Practices, and IRB policy. Identifies protocol content which conflicts with local or FDA requirements. Coordinates quarterly risk assessment with CRS Leadership to identify additional training and Quality Improvement Program needs within CRS and campus wide; makes recommendations to CRS leadership; implements new programs as approved.
Responsible for the development and implementation of the Quality Improvement Program for CRS which includes the Peer Review Program, Protocol Implementation process, Onboarding, Investigator Initiated Monitoring and maintenance compliance programs. Works closely with Team Leaders and CRS Leadership to ensure that all internal and external compliance procedures are followed. Responsible for maintaining annual QA/QC metrics.
Assists with the development of new metrics as needed. Provides quarterly report, at minimum. Conducts audits, analyzing results and reporting corrective actions needed to CRS Leadership and study staff; collects and organizes materials for audit, including the regulatory binder, subject research record, case report forms, medical records, test article accountability documents, screening and enrollment logs.
Interfaces with auditor, sponsor, government agency, investigator, and study coordinator as necessary to schedule clinical audit date, time, and place, (for internal and external audits). Prepares audit report and maintains the audit trail and archive. Manages the annual review of department Standard Operating Procedures (SOP’s) and makes recommendations for revisions based on updated regulations, process changes, etc.
Creates new SOP’s as needed and responsible for the implementation with all staff. Oversees the training tracker system and compiles list of investigators needing research training to avoid IRB submission delays; maintains CRS training and education binder; monitor for certification and license renewals. Supports educational programs and conferences to assist staff with research certification.
Establishes and maintains a template library of training documents that can be utilized by all CRS teams as well as other NCH departments. Education Requirement: Bachelor's Degree in healthcare or research related field or equivalent education and experience, required.
CCRC, CCRP, or equivalent certification through A ssociation of Clinical Research Professionals or Society of Clinical Research Associates, required.
Working knowledge of federal regulations including U. S. Food and Drug Administration (FDA), National Institute of Health (NIH), Department Health and Human Services (DHHS); International Conference on Harmonization Good Clinical Practices (ICH GCPs), study protocols, and IRB Policy.
Working knowledge of the day to day clinical research study process. Ability to teach according to different learning styles. Ability to deliver crucial feedback in a candid, compassionate manner.
Strong critical thinking and well-developed organizational skills with a demonstrated attention to detail. Strong written and verbal communication and presentation skills. Documented people skills with “hands on” management style.
Self-directed, results driven with the ability to manage workload. Working knowledge of PCs and word processing and data management software.
Five years of clinical research experience, required. Two years training or auditing experience, preferred. Physical
OCCASIONALLY: Color vision, Depth perception, Lifting / Carrying: 0-10 lbs, Peripheral vision, Pushing / Pulling: 0-25 lbs, Seeing – Far/near FREQUENTLY: Bend/twist, Climb stairs/ladder, Cold Temperatures, Reaching above shoulder, Squat/kneel, Standing, Walking CONTINUOUSLY: Audible speech, Computer skills, Decision Making, Flexing/extending of neck, Hand use: grasping, gripping, turning, Hearing acuity, Interpreting Data, Problem solving, Repetitive hand/arm use, Sitting "The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification.
It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M/F/Disability/Vet"