CRA - Site Management, Start-Up & Regulatory Compliance

At Target RWE, our mission is driven by a deep commitment to people-whether it's the patients we serve, the partners we collaborate with, or the dedicated team members who power our work. As a purpose-driven organization, we leverage real-world data to advance clinical research and inform better healthcare decisions. We foster a collaborative environment where every voice is heard, every idea has impact, and every contribution helps improve lives. If you're seeking a place where your work truly matters, join us to advance science.

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

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.

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.

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.

What You'll Bring

• Bachelor's degree and 2+ years of relevant experience in regulatory, clinical research, or site management within a CRO, pharmaceutical, or biotech company.
• 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.

If you are ready to be part of a team where your work truly matters - where your expertise is valued, your growth is supported, and your contributions help shape the future of healthcare, Target RWE is the place for you. We're building something meaningful together, and we'd love for you to be a part of it.

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.

What we offer you

• Hybrid + remote work environment

• Comprehensive health, dental, and vision for you and your family

• 401(k) with company match

• Generous PTO and company holidays

• Paid parental leave

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