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
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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