Regulatory Specialist

ObjectiveGI, Inc.; United States; Remote; USD 75,000 - 110,000; Full time

Benefits offered by this job

Competitive pay

401(k) with company match

Career path

Disability insurance

Health Savings Account

Health, dental & vision insurance

Generous PTO

Adoption support

Paid holidays

Voluntary benefits

Job summary

ObjectiveHealth seeks a Regulatory Specialist to coordinate and manage regulatory research activities across sites in the United States. You will prepare, review, file, and track study-specific regulatory documents, delegate authority forms, and training logs to ensure GCP compliance and timely milestones.

Collaborating with clinical study teams and leadership, you will ensure IRB submissions, informed consent review, and audits align with FDA/ICH guidance while maintaining up-to-date regulatory

Qualifications

• Bachelor’s degree in life sciences, healthcare, or related field preferred.
• 2+ years of experience in clinical research regulatory affairs or similar role.
• Strong understanding of GCP, ICH, FDA, and IRB processes.

Responsibilities

• Maintain regulatory start-up and ongoing documentation throughout clinical trials.
• Ensure compliance with IRB-approved protocols, sponsor requirements, SOPs, HIPAA, GCPs, and laws.
• Create, review, file, and submit regulatory and training documents with completeness and accuracy.
• Track physician credentials, training logs, and delegation of authority forms.
• Coordinate signatures and missing documentation to ensure timely completion.
• Collaborate with internal teams and sponsors to facilitate communication and issue resolution.
• Prepare IRB submissions (initial protocols, amendments, safety updates).
• Review and edit Informed Consent Forms for regulatory and protocol compliance.
• Participate in study start-up, monitoring visits, audits, and regulatory inspections.
• Maintain up-to-date knowledge of clinical research regulations, GCP, FDA/ICH guidance.
• Provide regulatory training to site staff as needed

Skills

Regulatory documentation

Attention to detail

Organizational skills

Communication skills

Education

Bachelor’s degree in life sciences or related field

Job description

The Regulatory Specialist is responsible for coordinating and participating in all regulatory research activities for all sites across ObjectiveHealth. This will include preparing, reviewing, managing and tracking study-specific regulatory documents and training documentation. This role will also require the maintenance of delegation of authority and training logs, as well as CVs, licenses, training certificates, etc., for key personnel. This individual works closely with the clinical study teams and Research Center leadership to ensure GCP compliance while meeting strict deadlines. A successful candidate is a team player, has prior experience in regulatory management, and is a detail-oriented self-starter.

Who We Are

ObjectiveHealth is a clinical research company that uses proprietary technology to:

• Increase patient access to research trials within our communities,
• Provide physicians with enhanced care options for current patients, and
• Deliver superior clinical research enrollment metrics to Pharma sponsors

All with the goal of Improving Patient Outcomes at the Point of Care. We want you to join us in doing just that.

Key Responsibilities

• Maintain regulatory start-up and ongoing documentation throughout clinical trials.
• Ensure compliance with all IRB-approved protocols, sponsor requirements, company SOPs, HIPAA regulations, GCPs, and applicable state and federal laws.
• Create, review, file, and submit regulatory and training documents, ensuring completeness and accuracy.
• Track and maintain physician credentials, training logs, and delegation of authority forms.
• Follow up on pending signatures and missing documentation to ensure timely completion.
• Collaborate with internal teams, research staff, investigators, and external sponsors to facilitate effective communication and issue resolution.
• Prepare IRB submissions (initial protocols, amendments, safety updates, etc.).
• Review and edit Informed Consent Forms for regulatory and protocol compliance.
• Participate in study start-up, monitoring visits, internal/external audits, and regulatory inspections.
• Maintain up-to-date knowledge of clinical research regulations, GCP, and FDA/ICH guidance.
• Provide regulatory training to site staff as needed

Qualifications

• Bachelor’s degree in life sciences, healthcare, or related field (preferred).
• 2+ years of experience in clinical research regulatory affairs or a similar role.
• Strong understanding of GCP, ICH guidelines, FDA regulations, and IRB processes.
• Excellent organizational, communication, and documentation skills.
• Ability to manage multiple priorities and deadlines with strong attention to detail.

What We Offer

• Competitive compensation
• 401(k) with Company match
• a clear career pathway for advancement within the Company
• Short- and Long-Term Disability
• Health Savings and Flexible Spending Accounts
• Health, Dental and Vision insurance Plans
• Generous PTO
• Adoption Assistance
• Paid Holidays
• a wide selection of other voluntary benefits

Requirements

This job requires legal authorization to work in the US. We are not currently accepting work visas. ObjectiveHealth is an EEO Employer and an E-Verify participant.