Postúlate en Kit Empleo: kitempleo.com.co/empleo/1aqp10

Job Description:

We are seeking a highly skilled and experienced Regulatory Specialist in Clinical Research to join our growing team. The idóneo candidate will have extensive experience in regulatory coordination, essential document management, IRB submissions, and ensuring compliance with clinical research regulations and sponsor requirements. Candidates must possess strong organizational skills, exceptional attention to detail, and a solid understanding of clinical research regulatory processes.

Key Responsibilities:

Regulatory Submissions: Prepare, submit, and maintain regulatory documents and submissions to Institutional Review Boards (IRBs), sponsors, and regulatory authorities.

Essential Document Management: Maintain and organize regulatory binders, essential documents, study files, and site documentation to ensure audit readiness at all times.

Compliance Oversight: Ensure clinical studies are conducted in compliance with GCP guidelines, FDA regulations, sponsor protocols, and site SOPs.

Study Start-Up Support: Assist with study start-up activities including collection of investigator documents, site credentials, training documentation, and regulatory approvals.

Continuing Reviews & Amendments: Prepare and submit continuing reviews, protocol amendments, deviations, safety reports, and study closures in a timely manner.

Documentation Tracking: Track regulatory deadlines, document expirations, training records, licenses, and IRB approvals to ensure ongoing compliance.

Audit Preparation: Support sponsor audits, monitoring visits, and regulatory inspections by ensuring complete and accurate documentation.

Collaboration: Work closely with Clinical Research Coordinators (CRCs),



investigators, sponsors, CROs, and study teams to support regulatory compliance throughout the study lifecycle.

Qualifications:

Experience: Minimum of 5 years of experience in clinical research regulatory coordination or regulatory specialist roles.

Clinical Research Knowledge: Strong understanding of FDA regulations, ICH-GCP guidelines, IRB processes, informed consent requirements, and clinical research compliance standards.

Documentation Skills: Experience handling regulatory binders, essential documents, and study start-up documentation.

Attention to Detail: Exceptional organizational and documentation skills with strong attention to detail and accuracy.

Communication Skills: Strong English verbal and written communication skills.

Tech-Savvy: Proficient in CTMS platforms, Microsoft Office, electronic regulatory systems, and document management systems.

Preferred Qualifications:

Experience working in a Clinical Research Organization (CRO), research site, or with study sponsors.

Experience supporting multi-site studies and sponsor audits is a plus.

CRC, CCRP, or ACRP certification is an advantage.

Job Type:
Full-time

Benefits:

Work from home

Schedule:

8-hour shift

Texas, USA business hours (8 AM to 5 PM CST)

Supplemental Pay:

Discretionary bonus

Experience:

Clinical Research Regulatory: 5 years (Required)

Experience with IRB submissions and regulatory documentation: 3 years (Required)

Experience with using CRIO as CTMS (Required)

Language:

English (Required)

Job Type: Full-time

Experience:

- Clinical Research: 5 years (Required)
- using CRIO as CTMS: 1 year (Required)

Language:

- English (Required)

Work Location: Remote

Postúlate en Kit Empleo: kitempleo.com.co/empleo/1aqp10

📌 [Remote] Clinical Research Regulatory Specialist (Texas, USA business hours) (Colombia)
🏢 GoAdvisors
📍 Colombia