Regulatory Specialist: Clinical Research Compliance

allied executive solutions; New Jersey; Hybrid; USD 95,000 - 125,000; Full time

Job summary

Allied Executive Solutions is seeking a Regulatory Specialist to manage regulatory documentation and ensure compliance for clinical research studies, trials, and human subjects research. This role supports study start-up, IRB submissions, and audit readiness, coordinating with sponsors, IRBs, and study teams to maintain inspection-ready files.

The ideal candidate will have a bachelor’s degree in a health-related field, strong organizational skills, and experience in regulatory documentation,

Qualifications

• Bachelor’s degree or related field preferred and relevant regulatory experience.
• Knowledge of human subjects protections, IRB processes, informed consent, and regulatory documentation.
• Strong organizational and document management skills.
• High attention to detail and ability to manage multiple deadlines.
• Strong written and verbal communication skills.

Responsibilities

• Prepare regulatory documents required for study activation and maintenance.
• Maintain complete, inspection-ready regulatory files for assigned studies.
• Prepare, submit, and track IRB applications, amendments, continuing reviews, and study closures.
• Communicate with IRBs, investigators, sponsors, and internal staff on status and changes.
• Track deadlines and ensure timely continuing reviews and renewals.
• Support training documentation and delegation of authority logs.
• Assist in responding to monitor findings and regulatory inspections.

Skills

Regulatory affairs

IRB coordination

Clinical research

Documentation management

Communication skills

Attention to detail

Deadline management

Audit readiness

Compliance orientation

Education

Bachelor’s degree in health sciences, public health, healthcare administration, regulatory affairs, life sciences, or related field

Tools

Microsoft Office

Adobe

electronic regulatory systems

document tracking tools

Job description

Allied Executive Solutions is seeking a Regulatory Specialist to manage regulatory documentation and ensure compliance for clinical research studies, trials, and human subjects research. This role supports study start-up, IRB submissions, and audit readiness, coordinating with sponsors, IRBs, and study teams to maintain inspection-ready files.

The ideal candidate will have a bachelor’s degree in a health-related field, strong organizational skills, and experience in regulatory documentation,