Clinical Research Regulatory Specialist

Jobgether; United States; Remote; USD 55,000 - 75,000; Full time

Benefits offered by this job

Remote work

Professional development

Impactful work

Collaborative culture

Career growth

Purpose-driven culture

Job summary

Jobgether is seeking an Regulatory Affairs/Clinical Research Support specialist to coordinate IRB submissions, regulatory documentation, and site credential management. The role involves managing electronic regulatory systems, preparing essential regulatory documents, and ensuring compliance across study startup and maintenance.

Ideal candidates have 1–2 years in clinical research with regulatory focus, a GCP certificate, and strong attention to detail.

Qualifications

• 1–2 years of clinical research experience, preferably with regulatory affairs, regulatory documentation, or quality assurance.
• Current Good Clinical Practice (GCP) certification.
• Strong understanding of ICH/GCP guidelines and HIPAA policies.
• Familiarity with clinical research regulatory documentation, IRB submissions, investigator site files, and startup/maintenance procedures.
• Excellent written and verbal communication skills in English.

Responsibilities

• Coordinate study startup activities including IRB submissions, regulatory documentation, vendor access, and staff training access.
• Support electronic regulatory document management by creating electronic study binders and filing startup/maintenance documents, performing quality checks.

Skills

Regulatory documentation

GCP knowledge

Communication

Attention to detail

Independent work

Education

Bachelor's degree preferred

Tools

Microsoft Excel

Adobe Acrobat

Job description

Accountabilities:

- Clinical Study Startup: Coordinate study startup activities, including Institutional Review Board (IRB) submissions, regulatory documentation, vendor access, staff training access, and other essential preparation requirements.

- Electronic Regulatory Document Management: Support the administration of the Florence eRegulatory platform by creating electronic study binders, filing startup and maintenance documents, conducting quality checks, and monitoring investigator and site credentials.

- Regulatory Documentation: Prepare, review, and maintain essential regulatory documents, including Financial Disclosure Forms (FDFs), Protocol Signature Pages (PSPs), FDA Form 1572s, and Investigator Brochure Signature Pages.

- Document Coordination & Follow-Up: Distribute regulatory documents to investigators and research staff for review and signatures, monitor outstanding requirements, and coordinate follow-ups to ensure timely completion.

- Sponsor & CRO Communication: Submit completed regulatory documentation and investigator credentials to sponsors and Contract Research Organizations (CROs) within established deadlines.

- Study Personnel Documentation: Create and maintain delegation of authority logs and training logs, ensuring they remain accurate and up to date throughout each study.

- Regulatory Quality Assurance: Review Investigator Site Files (ISFs) to verify document completeness, accuracy, consistency, and compliance with applicable regulatory requirements.

- Site Selection Visit Preparation: Gather and organize documentation requested during Site Selection Visits (SSVs), including investigator and research staff CVs, medical licenses, Good Clinical Practice (GCP) training certificates, internal SOPs, and equipment calibration records.

- Investigator Credential Management: Prepare investigator CVs, coordinate biannual updates or revisions as requested, and obtain and maintain valid medical licenses for all investigators.

- IRB Submissions & Study Maintenance: Prepare and submit continuing reviews, protocol deviations, and other ongoing IRB documentation to support study compliance throughout the research lifecycle.

- Standard Operating Procedures: Contribute to the development and improvement of company Standard Operating Procedures (SOPs) and Guidance Documents (GDs) as needed.

- Additional Responsibilities: Perform other regulatory, administrative, and research-related duties as assigned to support clinical study operations and departmental objectives.

Requirements:

- High school diploma or equivalent required; a bachelor's degree is preferred.

- 1–2 years of clinical research experience, preferably with a focus on regulatory affairs, regulatory documentation, or quality assurance.

- Current Good Clinical Practice (GCP) certification.

- Relevant professional licenses or certifications, including continuing education units (CEUs), where applicable.

- Sound understanding of medical terminology and clinical research processes.

- Working knowledge of ICH/GCP guidelines, applicable regulatory requirements, FDA regulations, and HIPAA policies and practices.

- Familiarity with clinical research regulatory documentation, IRB submissions, investigator site files, and study startup and maintenance procedures.

- Strong proficiency in Microsoft Office, particularly Microsoft Excel, as well as Adobe Acrobat and related document management tools.

- Excellent written and verbal communication skills, with fluency in spoken and written English.

- Strong interpersonal skills and the ability to collaborate effectively with clinicians, patients, administrators, research personnel, regulatory authorities, monitors, and sponsors.

- Exceptional attention to detail and a commitment to maintaining accurate, complete, and compliant regulatory records.

- Strong organizational and time management abilities, with the capacity to manage multiple priorities and changing deadlines.

- Ability to consult multiple information sources, gather relevant documentation, and prepare accurate regulatory materials.

- High level of professionalism, discretion, and commitment to maintaining confidential information.

- Ability to work independently while contributing effectively to a collaborative, multidisciplinary research team.

Benefits:

- Remote Work: Opportunity to work remotely from within the United States.

- Professional Development: Opportunities to expand clinical research regulatory knowledge and develop expertise in regulatory compliance and quality assurance.

- Meaningful Impact: Contribute to clinical research initiatives focused on bringing innovative treatments to patients and improving community health.

- Collaborative Work Environment: Join a supportive, team-oriented workplace that values communication, integrity, humility, and shared accountability.

- Career Growth: Opportunities to strengthen your professional skills and pursue long-term development within the clinical research field.

- Purpose-Driven Culture: Work in an environment that prioritizes people, patient communities, teamwork, and high-quality research outcomes.