Regulatory Coordinator

Neuro Behavioral Research, Inc

North Canton, OHFull-time

22–27 an hour

Behavioral Health Market Context

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Benefits

Pay: $22.00 - $27.00 per hourExpected hours: 40 per week401(k)401(k) matchingDental insuranceHealth insuranceLife insurancePaid time offVision insurance

Job Description

Position Overview:

We are located in Northeast Ohio and we are seeking a detail-oriented and proactive Regulatory Coordinator to join our dynamic team at Neuro-Behavioral Clinical Research. The ideal candidate will be responsible for ensuring the regulatory compliance and conducting feasibility assessments for clinical research studies.

Key Responsibilities:
• Manage and maintain regulatory documentation for clinical trials, ensuring compliance with all local, state, and federal regulations.
• Coordinate and facilitate regulatory submissions to institutional review boards (IRBs) and regulatory authorities (e.g., FDA, EMA).
• Prepare, submit, and track ethics committee and IRB submissions and approvals.
• Work closely with clinical research teams to ensure proper feasibility assessments are conducted prior to trial initiation.
• Evaluate potential clinical sites and assess their suitability for conducting trials based on factors such as patient population, resources, and site experience.
• Coordinate with sponsors and CROs to ensure all regulatory and feasibility requirements are met.
• Ensure timely completion of all regulatory and feasibility documentation, including study protocols, informed consent forms, and site contracts.
• Ensure compliance with Good Clinical Practice (GCP), ICH, and other relevant regulations.

Qualifications:
• Bachelor’s degree in Life Sciences, Nursing, or a related field (preferred).
• Previous experience in regulatory affairs or clinical research (1-3 years is preferred).
• Strong knowledge of FDA, GCP, ICH, and other applicable regulatory requirements.
• Familiarity with clinical trial design and feasibility analysis.
• Excellent organizational, communication, and interpersonal skills.
• Ability to manage multiple tasks and prioritize effectively.
• Strong attention to detail and ability to work independently and in a team setting.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and other related software.

Job Type: Full-time

Pay: $22.00 - $27.00 per hour

Expected hours: 40 per week

Benefits:
• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Ability to Commute:
• North Canton, OH 44720 (Required)

Ability to Relocate:
• North Canton, OH 44720: Relocate before starting work (Required)

Work Location: In person

Qualifications

  • Strong knowledge of FDA, GCP, ICH, and other applicable regulatory requirements
  • Familiarity with clinical trial design and feasibility analysis
  • Excellent organizational, communication, and interpersonal skills
  • Ability to manage multiple tasks and prioritize effectively
  • Strong attention to detail and ability to work independently and in a team setting
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and other related software
  • North Canton, OH 44720 (Required)
  • North Canton, OH 44720: Relocate before starting work (Required)

Responsibilities

  • The ideal candidate will be responsible for ensuring the regulatory compliance and conducting feasibility assessments for clinical research studies
  • Manage and maintain regulatory documentation for clinical trials, ensuring compliance with all local, state, and federal regulations
  • Coordinate and facilitate regulatory submissions to institutional review boards (IRBs) and regulatory authorities (e.g., FDA, EMA)
  • Prepare, submit, and track ethics committee and IRB submissions and approvals
  • Work closely with clinical research teams to ensure proper feasibility assessments are conducted prior to trial initiation
  • Evaluate potential clinical sites and assess their suitability for conducting trials based on factors such as patient population, resources, and site experience
  • Coordinate with sponsors and CROs to ensure all regulatory and feasibility requirements are met
  • Ensure timely completion of all regulatory and feasibility documentation, including study protocols, informed consent forms, and site contracts
  • Ensure compliance with Good Clinical Practice (GCP), ICH, and other relevant regulations


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