Regulatory Research Coordinator Lead - RI Gene Ther

Summary

Oversees the orientation, day to day supervision and continuing professional development of team members through ongoing guidance and support in all aspects of conducting clinical research projects.

Ensures all clinical research trials are managed uneventfully, safely, and as effectively as possible, and that all elements of a clinical research trial meet all protocol obligations while following applicable regulations; Code of Federal Regulations Good Clinical Practices (GCP) and International Conference on Harmonization GCP guidelines; state regulations and departmental/institutional standard operating procedures.

Essential Functions

• Provides guidance/support to members of staff in coordinating all of the elements of research studies to ensure that they progress effectively and efficiently to meet the enrollment for the target number of patients and that data quality is maintained.
• Oversees quality control/quality assurance measures within their team and their own work; ensuring proper study start-up, study enrollment, study documentation, and study protocol adherence (as require.

Provides guidance/oversight to team members in all aspects of clinical study coordination as well as patient safety; troubleshoots clinical study issues including those issues that have operational, compliance and/or regulatory impact. Manages a study portfolio, (if applicable.

Performs research activities as outlined in the protocol; conducts subject data collection and performs study protocol procedures according to recognized skill level and certifications; collaborates, coordinates, and schedules subject study visits with other hospital services and the PI/sub-I; alerts the investigator when the subject's safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination.

• Provides support for regulatory/IRB issues for their team after a study has been initiated by the study sponsor, if applicable.
• Ensures data quality by closely monitoring/coaching their team during all phases of research implementation and conduct.
• Onboards and trains new hires and assists with performance management.
• Education Requirement: Bachelor's degree required, would consider work experience in lieu of degree.

Licensure Requirement: Valid Ohio driver's license and proof of auto insurance as required by hospital policy and position-specific requirements. Must pass motor vehicle background inspection, insurance eligibility, driving qualifications, and training set forth by Nationwide Children's Hospital and maintain qualification of insurance guidelines.

• Certifications: Certified as a clinical research professional required, (SOCRA or ACRP), or eligible within six months of hire.
• Skills: In depth knowledge of FDA and IRB regulations required.
• Demonstrated leadership abilities.
• Advanced understanding of medical terminology required.
• Excellent verbal and written communication skills.
• Demonstrated analytical skills with accuracy and attention to detail.

• Organizes, analyzes and prioritizes workflow.
• Demonstrated computer and software application skills, (Microsoft Office Suite).
• Experience: 2 years of experience in managing clinical research projects, required.
• Highly experienced and knowledgeable in coordinating research activities and responsibilities.
• Physical

Requirements

Occasionally

Cold Temperatures, Driving motor vehicles (work required) *additional testing may be required, Fume /Gases /Vapors, Loud Noises, Reaching above shoulder, Squat/kneel FREQUENTLY: Bend/twist, Biohazard waste, Blood and/or Bodily Fluids, Chemicals/Medications, Communicable Diseases and/or Pathogens, Lifting / Carrying: 0-10 lbs, Lifting / Carrying: 11-20 lbs, Lifting / Carrying: 21-40 lbs, Machinery, Patient Equipment, Pushing / Pulling: 0-25 lbs, Pushing / Pulling: 26-40 lbs, Pushing / Pulling: 41-60 lbs, Pushing / Pulling: 61-100 lbs, Sitting, Standing, Walking CONTINUOUSLY: Audible speech, Computer skills, Decision Making, Depth perception, Flexing/extending of neck, Hand use: grasping, gripping, turning, Hearing acuity, Interpreting Data, Peripheral vision, Problem solving, Repetitive hand/arm use, Seeing - Far/near "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"