Site Activation Specialist - US

Worldwide

Durham (NC)

Remote

USD 60,000 - 119,000

Full time

4 days ago
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Benefits offered by this job

Remote work opportunity

Job summary

Worldwide Clinical Trials is seeking a Site Activation Specialist for a remote US-based role, with Durham, NC as a reference location. You will coordinate site regulatory activities, support activation milestones, and partner with cross-functional teams to ensure timely study start-up and regulatory readiness.

Ideal candidates hold a bachelor’s degree in a related scientific field and have 1+ year of clinical research experience, with strong knowledge of ICH GCP and regulatory requirements.

Qualifications

  • 1+ year of clinical research experience, preferably in site activation or regulatory roles.
  • Knowledge of ICH GCP and regulatory guidance.
  • Strong organizational and communication skills.

Responsibilities

  • Coordinate collection and maintenance of site regulatory documents for activation.
  • Ensure timely completion of start-up activities and activation milestones.
  • Review regulatory documentation to identify gaps and drive corrective actions.
  • Support informed consent development and site-specific documentation.
  • Coordinate site feasibility, confidentiality agreements, and site qualification.
  • Monitor submission activities and communicate status to teams.
  • Contribute to country/site intelligence for study planning and activation.
  • Maintain SOPs, ICH GCP compliance, and study processes.

Skills

Clinical research
Site activation
Regulatory documentation
Communication
Organization

Education

Bachelor's degree

Tools

Microsoft Word
Excel
PowerPoint

Job description

Site Activation Specialist - USWe use cookies to improve your browsing experience and help us improve our websites. We have carefully selected third parties that use cookies to achieve purposes illustrated in the cookie policy. For more information. Read more about online privacy statement. By closing this banner or continuing to browse our website, you agree to our use of such cookies.https://www.worldwide.com/privacy-statement-terms-of-use/online-privacy-statement/# Discover a world of difference at Worldwide.## Site Activation Specialist - USApply: Remote: Durham, North Carolina: Full time: Posted Yesterday: JR103315Join a global Contract Resource Organization (CRO) where innovation meets purpose. At **Worldwide Clinical Trials**, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world. With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research. ## Make an Impact as a Site Activation Specialist at Worldwide Play a key role in bringing clinical research studies to life by supporting site activation and maintenance activities that help ensure studies start on time and remain compliant throughout delivery. In this role, you'll partner closely with Site Activation Managers, regulatory teams, study sites, and cross-functional stakeholders to keep critical start-up activities moving forward efficiently and accurately. Your work will directly contribute to the quality and completeness of essential regulatory documentation, site readiness, and study activation milestones. From supporting site feasibility and qualification activities to coordinating essential document collection and review, you'll help create a strong foundation for successful clinical trial execution. Working within a collaborative global environment, you'll build relationships with investigators, site personnel, and internal teams while helping deliver high-quality outcomes that support clinical research and patient-focused innovation. ## Where You'll WorkThis is a REMOTE role open to candidates based in Remote. You will collaborate with global teams across multiple time zones. ## What You'll Do* Coordinate the collection, tracking, review, and maintenance of site regulatory and essential documents to support site activation and ongoing study requirements.* Partner with study teams, sites, and functional stakeholders to ensure timely completion of start-up activities and activation milestones.* Review study-specific regulatory documentation, identify gaps or quality issues, and drive corrective actions prior to final approval.* Support the development, adaptation, and review of country- and site-specific informed consent documentation.* Facilitate site identification and feasibility activities, including confidentiality agreements, feasibility questionnaires, and site qualification efforts.* Monitor site and country-level submission activities and communicate status updates to internal teams and project stakeholders.* Contribute to country and site intelligence gathering to support study planning, site selection, and activation strategies.* Maintain compliance with applicable SOPs, ICH GCP guidelines, regulatory requirements, and study-specific processes while supporting continuous quality delivery. ## What You'll Bring* Bachelor's degree in medical, biological, physical, health, pharmacy, or another related scientific discipline, with at least one year of clinical research experience, preferably in site activation or a regulatory-focused role.* Previous experience within the pharmaceutical, biotechnology, or CRO industry.* Working knowledge of ICH GCP, EU Clinical Trials Directive, and other relevant clinical research regulations and guidance.* Strong understanding of clinical research processes, site activation activities, and regulatory documentation requirements.* Excellent organizational, prioritization, and time management skills with the ability to manage multiple activities in a fast-paced environment.* Strong written and verbal communication skills and the ability to collaborate effectively with cross-functional teams and study sites.* Proficiency with Microsoft Word, Excel, PowerPoint, and other contemporary digital systems.* Proficiency in English required; multilingual language capabilities and fluency in the local language preferred. **Discover the Difference** We love knowing that someone is going to have a better life because of the work we do. Discover the Difference at Worldwide Clinical Trials. Explore additional opportunities on our careers page, visit **http://www.worldwide.com/careers**, or connect with us on **LinkedIn**. At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation. The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates): United States of America - $60,000.00 - $119,000.00The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage. Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law**.**
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