Senior Regulatory Specialist, Clinical Trials

allied executive solutions; New Jersey; Hybrid; USD 70,000 - 110,000; Full time

Job summary

Allied Executive Solutions is seeking a Regulatory Specialist to manage regulatory documentation and ensure compliance for clinical research studies. You will support start-up activities, IRB submissions, document control, and audit readiness in a hybrid work setting.

The role requires knowledge of human subjects protections, strong organizational skills, and experience in regulatory affairs or healthcare administration. Collaboration with sponsors, investigators, and monitors is key.

Qualifications

• Bachelor’s degree in health sciences or related field.
• Experience in clinical research or regulatory affairs.
• Knowledge of human subjects protections and IRB processes.
• Strong organizational and document management skills.
• Attention to detail and ability to meet deadlines.
• Strong written and verbal communication.
• Proficiency with Microsoft Office, Adobe, shared drives, electronic regulatory systems.

Responsibilities

• Regulatory study start-up: review protocols, consent forms, and sponsor materials.
• Prepare and coordinate regulatory documents for study activation.
• Maintain regulatory binders and essential documents.
• Ensure approvals before study activities begin.
• IRB submissions and maintenance: prepare, submit, and track IRB applications and amendments.
• Maintain current IRB approvals and consent documents.
• Track submission deadlines and renewals.
• Communicate with IRBs, investigators, sponsors, and staff.

Skills

Regulatory affairs

IRB coordination

Documentation

GxP knowledge

Microsoft Office

Education

Bachelor’s degree in health sciences

Clinical research experience

Tools

Electronic regulatory systems

IRB systems

Adobe Acrobat

Job description

Allied Executive Solutions is seeking a Regulatory Specialist to manage regulatory documentation and ensure compliance for clinical research studies. You will support start-up activities, IRB submissions, document control, and audit readiness in a hybrid work setting.

The role requires knowledge of human subjects protections, strong organizational skills, and experience in regulatory affairs or healthcare administration. Collaboration with sponsors, investigators, and monitors is key.