Senior Clinical Research Program Coordinator

Nationwide Children's HospitalColumbus, OH
Onsite

About The Position

This role oversees administrative operations for multi-center clinical trials, projects, and portfolios within the Clinical Research Office (CRO). The coordinator is responsible for achieving program goals through excellent interpersonal communication during multi-center study start-ups, consortium development, and department or center portfolio development. Key functions include coordinating and managing clinical research studies, ensuring compliance with protocols and regulations, developing and maintaining study budgets, and tracking expenses. The position also involves overseeing the IRB process, ensuring sites submit complete, accurate, and timely IRB submissions, and maintaining associated regulatory documents. Responsibilities extend to recruiting and screening potential study participants, obtaining informed consent, and collecting, analyzing, and maintaining accurate study data and records. The coordinator identifies areas of risk, implements new or revised processes, collaborates on new process creation, and improves efficiencies for overall program success. Collaboration and communication with study sponsors, investigators, and staff are essential, as is assisting with orientation and training and implementing training materials. The role also requires preparing and submitting study progress reports to regulatory agencies and study sponsors. A valid Ohio driver’s license, proof of auto insurance, and passing a motor vehicle background inspection, insurance eligibility, driving qualifications, and training set forth by Nationwide Children’s Hospital are required.

Requirements

  • Valid Ohio driver’s license and proof of auto insurance is required by hospital policy.
  • Must pass a motor vehicle background inspection, insurance eligibility, driving qualifications and training set forth by Nationwide Children’s Hospital and must maintain qualification of insurance guidelines.
  • Associate degree, required.
  • CCRC or CCRP certification within 12 months of hire and maintained throughout employment, required.
  • Demonstrated leadership skills.
  • Strong organizational skills.
  • Exceptional interpersonal, written, and verbal communication.
  • Ability to filter information, discern importance and initiate plan for project completion.
  • Self-directed, results driven with the ability to manage workload.
  • Ability to work independently and as part of a team.
  • Working knowledge of data management software.
  • Three years’ experience in clinical research or healthcare related field, required.

Nice To Haves

  • Bachelor’s Degree, preferred.

Responsibilities

  • Coordinates and manages clinical research studies and ensures compliance with protocols and regulations.
  • Develops and maintains study budgets and tracks expenses.
  • Oversees IRB process, ensures sites are submitting complete, accurate and timely IRB submissions, and maintains associated regulatory documents.
  • Recruits and screens potential study participants and obtains informed consent.
  • Collects, analyzes, and maintains accurate study data and records.
  • Identifies areas of risk and implements new or revised processes, collaborates to create new processes, and improves efficiencies to ensure overall program success.
  • Collaborates and communicates with study sponsors, investigators, and staff.
  • Assists with orientation and training and implements training materials.
  • Prepares and submits study progress reports to regulatory agencies and study sponsors.
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