CRA - Site Management, Start-Up & Regulatory Compliance

Summary

We are seeking a detail-oriented Clinical Research Associate (CRA) with a strong focus on site start-up, regulatory compliance, and site management. This role will provide essential document guidance to clinical sites and program team members in accordance with ICH/Good Clinical Practice (GCP) Guidelines, the Code of Federal Regulations, and company SOPs. The CRA will play a pivotal role in ensuring efficient site activation, resolving IRB-related challenges, and supporting clinical program teams throughout the study lifecycle.

What You'll Do

Key Responsibilities:

1. Site Start-Up, Management & Regulatory Compliance

• Lead and coordinate site start-up activities to ensure timely activation, including site feasibility, regulatory submissions, and contract execution.
• Manage essential document completion and provide regulatory guidance to clinical sites and program team members during start-up, maintenance, and close-out phases.
• Develop and negotiate Informed Consent Forms (ICFs) with clinical sites to ensure compliance with regulatory requirements and site-specific considerations.
• Oversee site qualification, initiation, and routine monitoring visits to assess compliance and study progress.
• Compile and distribute Site Regulatory Binders, ensuring completeness, accuracy, and timely delivery.
• Set up and maintain the Trial Master File (TMF), ensuring document review for accuracy, completeness, and audit readiness.
• Collaborate with the Health System Relationship Leader to strengthen site relationships, expedite start-up timelines, and resolve regulatory or operational challenges.

2. Regulatory & IRB Management

• Conduct Investigator Site File (ISF) reviews and technical quality control activities to ensure all essential regulatory documents remain audit- and FDA inspection-ready throughout the study.
• Manage study-level Central IRB submissions, ensuring timely and compliant electronic uploads or email submissions.
• Address and resolve IRB-related challenges, including site-specific regulatory hurdles that may impact study timelines.
• Periodically update ClinicalTrials.gov to maintain compliance with regulatory reporting requirements.

3. Operational Support & Documentation

• Audit and maintain clinical tracking systems to ensure accurate site and study documentation throughout the study lifecycle.
• Identify and troubleshoot site start-up delays, regulatory document discrepancies, and operational inefficiencies to facilitate smooth study execution.
• Actively participate in cross-functional team discussions and decision-making to enhance site management and regulatory processes.
• Ensure regulatory compliance by proactively identifying and mitigating potential risks related to site activation and document management.

Qualifications

• Education & Experience:
  • Bachelor's degree and 2+ years of relevant experience in regulatory, clinical research, or site management within a CRO, pharmaceutical, or biotech company.
  • An equivalent combination of education and experience may be considered.

• Additional Qualifications:
  • Strong knowledge of site start-up processes, including regulatory submissions, IRB approvals, essential document collection, and site activation workflows.
  • Proficiency in Microsoft Office applications and clinical trial management systems.
  • General knowledge of FDA/EMEA regulations, ICH/GCP Guidelines, and regulatory requirements for site activation.
  • Excellent written and verbal communication skills to liaise effectively with internal teams and external stakeholders.
  • Strong attention to detail and organizational skills to manage multiple priorities in a fast-paced, multi-study environment.
  • Ability to identify, analyze, and resolve site start-up and IRB-related challenges proactively.
  • Strong relationship-building skills to foster positive interactions with clinical sites, sponsors, and regulatory bodies, ensuring smooth study execution.

Total Rewards

The salary estimated for this position is $62,000-92,000 per year. Compensation will vary depending on job-related knowledge, skills and experience. Actual compensation will be confirmed in writing at the time of offer.

Why Target RWE

• Fast-moving, high-growth, biotechnology company
• The opportunity to impact healthcare and improve peoples' quality of life
• Work remote / from home culture that is flexible and no-nonsense
• Smart and easy-going colleagues
• 401(K) with a company match

Hybrid role: 1 day per week in office located in Raleigh/Durham, NC or Dallas, TX