The Senior Clinical Research Training and Compliance Coordinator plays an integral role in the training and compliance processes of clinical research conducted in GTO and throughout NCH. This process includes development and implementation of a variety of clinical research topics as well as quality assurance audits to enhance compliance with regulations.
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.
Essential Functions:
- Develops and implements clinical research education training both within the assigned research unit and throughout the NCH campus.
- Works with research leadership to establish and maintain a consistent on-boarding/orientation process for all new hires. 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.
- Develops and implements risk assessment with research leadership to identify additional training and Quality Improvement Program needs within the research unit. Makes recommendations to research leadership and implements new programs as approved.
- Collaborates with team leaders and research leadership to ensure that all internal and external compliance procedures are followed. Maintains annual QA/QC metrics and assists with the development of new metrics as needed. Provides quarterly report, at minimum.
- Conducts audits, analyzing results and reporting corrective actions needed to research 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 to ensure training is occuring in a timely manner.
- 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 research unit teams as well as other NCH departments.
Education Requirement:
Bachelor's Degree in healthcare or research related field, or equivalent education and experience, required.
Certifications:
Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP), required.
Skills:
- 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.
Experience:
- Three years of clinical research experience, required.
- Two years training or auditing experience, preferred.
Physical Requirements:
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"
