Regulatory & Start Up Specialist, Cfsp

3+ years

Not Disclosed

Mexico

11 Nov. 23, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Regulatory & Start-Up Specialist

Location

Home-Based (Argentina & México)

Role Overview

Join our cFSP team as a Regulatory & Start-Up Specialist to perform country-level site activation (SA) tasks in compliance with local and international regulations, SOPs, project requirements, and contractual/budgetary guidelines.

Key Responsibilities

Site Activation Tasks
- Serve as the Single Point of Contact (SPOC) for assigned studies, liaising with investigative sites, Site Activation Managers (SAMs), Project Management teams, and other departments.
- Conduct start-up and site activation activities as per applicable regulations, SOPs, and work instructions.
- Prepare and review site regulatory documents for completeness and accuracy.
- Oversee document distribution to sites and internal project teams.
Regulatory Compliance and Tracking
- Ensure adherence to SOPs, Work Instructions (WIs), and quality standards for deliverables and project timelines.
- Maintain and update internal systems, databases, and tracking tools with project-specific details.
- Review, track, and manage the progress, approval, and execution of key documents, including regulatory approvals, ethics submissions, Informed Consent Forms (ICFs), and Investigator Pack (IP) releases.
Local Expertise
- Provide local regulatory expertise to SAMs and project teams during both initial and ongoing project timeline planning.
- Support submissions to regulatory authorities (e.g., COFEPRIS, ANMAT) and ethics committees.
Quality Assurance
- Conduct quality control reviews of documents provided by sites.
- Ensure alignment with GCP/ICH guidelines and applicable regulatory standards.
Stakeholder Interaction
- Act as a liaison for sponsors on specific project initiatives, ensuring seamless communication and deliverables.

Qualifications & Skills

Education:
Health Sciences degree or related field.
Experience:
- Minimum of 3 years of clinical research experience in the regulatory domain.
- Proven expertise in local regulatory submissions, ethics committee presentations, and familiarity with COFEPRIS/ANMAT requirements.
Technical Knowledge:
- Comprehensive knowledge of GCP/ICH and applicable regulatory guidelines.
- Proficiency in handling Informed Consent Forms (ICFs) and regulatory document submissions.
Language:
- Advanced proficiency in English.
Skills:
- Strong organizational and time management abilities.
- Effective communication and interpersonal skills.

Why Join Us?

Be a part of a dynamic and collaborative environment, contributing to impactful clinical research projects that comply with global standards. Apply your expertise in regulatory processes while working with a global team to advance healthcare innovation.

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Regulatory & Start Up Specialist, Cfsp

Job Description

Job Description: Regulatory & Start-Up Specialist

Location

Role Overview

Key Responsibilities

Qualifications & Skills

Why Join Us?

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