Clinical Research Manager
60K–80K a year
Behavioral Health Market Context
Apply Nowvia Learn4Good
Job Description
coordinators and nurses, to ensure high-quality study execution.
• Oversee all phases of clinical studies, from initiation and enrollment to close-out, across several protocols.
• Act as the main operational contact for external partners and regulatory monitors during audits and site visits.
• Maintain strict adherence to regulatory guidelines, including FDA, ICH/GCP, and internal procedures.
• Review and approve essential study documentation, regulatory submissions, and protocol deviations.
• Monitor enrollment progress, identify challenges, and implement solutions to achieve study milestones.
• Coordinate with investigators, IRB, and administrative teams to keep studies on schedule and within budget.
• Lead recruitment, onboarding, and training of new research staff, and support the development of SOPs and training programs.
Qualifications
• Minimum 5 years of clinical research experience, including at least 1–2 years in a supervisory or lead role.
• Comprehensive knowledge of FDA regulations, ICH/GCP guidelines, and research compliance standards.
• Demonstrated ability to manage multiple studies across various therapeutic areas simultaneously.
• Proficiency with clinical trial management systems, electronic data capture platforms, and regulatory documentation.
• Certification such as CCRP, CCRC, or ACRP-CP preferred.
• Bachelor’s degree required; preferred fields include life sciences, nursing, or healthcare.
#J-18808-Ljbffr
• Oversee all phases of clinical studies, from initiation and enrollment to close-out, across several protocols.
• Act as the main operational contact for external partners and regulatory monitors during audits and site visits.
• Maintain strict adherence to regulatory guidelines, including FDA, ICH/GCP, and internal procedures.
• Review and approve essential study documentation, regulatory submissions, and protocol deviations.
• Monitor enrollment progress, identify challenges, and implement solutions to achieve study milestones.
• Coordinate with investigators, IRB, and administrative teams to keep studies on schedule and within budget.
• Lead recruitment, onboarding, and training of new research staff, and support the development of SOPs and training programs.
Qualifications
• Minimum 5 years of clinical research experience, including at least 1–2 years in a supervisory or lead role.
• Comprehensive knowledge of FDA regulations, ICH/GCP guidelines, and research compliance standards.
• Demonstrated ability to manage multiple studies across various therapeutic areas simultaneously.
• Proficiency with clinical trial management systems, electronic data capture platforms, and regulatory documentation.
• Certification such as CCRP, CCRC, or ACRP-CP preferred.
• Bachelor’s degree required; preferred fields include life sciences, nursing, or healthcare.
#J-18808-Ljbffr
Qualifications
- •Minimum 5 years of clinical research experience, including at least 1–2 years in a supervisory or lead role
- •Comprehensive knowledge of FDA regulations, ICH/GCP guidelines, and research compliance standards
- •Demonstrated ability to manage multiple studies across various therapeutic areas simultaneously
- •Proficiency with clinical trial management systems, electronic data capture platforms, and regulatory documentation
Benefits
Responsibilities
- •Relocation Support Provided
- •Seeking an experienced professional to lead and manage clinical research operations, ensuring compliance, efficiency, and effective team leadership across multiple studies
- •Supervise and mentor research staff, including coordinators and nurses, to ensure high-quality study execution
- •Oversee all phases of clinical studies, from initiation and enrollment to close-out, across several protocols
- •Act as the main operational contact for external partners and regulatory monitors during audits and site visits
- •Maintain strict adherence to regulatory guidelines, including FDA, ICH/GCP, and internal procedures
- •Review and approve essential study documentation, regulatory submissions, and protocol deviations
- •Monitor enrollment progress, identify challenges, and implement solutions to achieve study milestones
- •Coordinate with investigators, IRB, and administrative teams to keep studies on schedule and within budget
- •Lead recruitment, onboarding, and training of new research staff, and support the development of SOPs and training programs
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