Site Start Up Associate
Target RWE
Date: 12 hours ago
City: Mesquite, TX
Salary:
$62,000
-
$92,000
per year
Contract type: Contractor

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 an experienced and detail-oriented Site Start-Up Associate with a strong focus on regulatory, site start up, and document review. 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 individual 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, Contracting & Regulatory Compliance
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
We are seeking an experienced and detail-oriented Site Start-Up Associate with a strong focus on regulatory, site start up, and document review. 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 individual 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, Contracting & Regulatory Compliance
- Lead and coordinate site start-up activities to ensure timely activation, including 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.
- 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.
- 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.
- 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.
- Bachelor's degree and 4 years of clinical research experience including a minimum of two years specific to site start up or an Associate's degree with 6 years of clinical research experience including a minimum of 3 years specific to site start up
- 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.
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
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