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Clinical Research Associate II - Oncology (US)
Worldwide · Durham, North Carolina
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Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us! Make an Impact as a Clinical Research Associate II at Worldwide As a Clinical Research Associate II, you’ll play a critical role in ensuring clinical studies are conducted to the highest standards of quality, compliance, and patient safety. Your work will directly support the successful delivery of clinical research by partnering with investigative sites and study teams throughout the study lifecycle. In this role, you’ll take ownership of site qualification, initiation, monitoring, management, and close-out activities while helping ensure accurate, timely, and reliable study data. You’ll serve as a trusted resource for site personnel, providing guidance, training, and support to promote protocol adherence and regulatory compliance. Working across multiple stakeholders, you’ll contribute to the success of clinical trials by driving data quality, supporting safety reporting, and maintaining strong site relationships that help advance important research programs. Where You'll Work This is a home-based Clinical Research Associate role supporting sites across the United States. Candidates must reside within the territory to effectively support site visits and study activities. You will collaborate with sites, sponsors, and global study teams while traveling to investigative sites approximately [X-X] days per month. To best support our sites, we're seeking candidates who are based in the United States. Travel will primarily be regional, with occasional travel to support sites in other locations as needed. What You'll Do
- Conduct site qualification, initiation, monitoring, and close-out visits in accordance with study protocols, GCP requirements, and applicable regulations.
- Evaluate site feasibility and readiness to support successful study execution.
- Review and maintain essential regulatory, ethics, and study documentation to ensure compliance and inspection readiness.
- Train and support site personnel on protocol requirements, study procedures, and data quality expectations.
- Verify source documentation and review study data to ensure accuracy, completeness, and protection of patient safety.
- Partner with sites to resolve data queries, maintain investigator files, and support timely study deliverables.
- Monitor investigational product accountability, including receipt, storage, return, or destruction activities.
- Prepare detailed visit reports and provide updates for inclusion in the Trial Master File.
- Collaborate with study teams and contribute expertise to protocol, CRF, and monitoring plan development when requested. What You'll Bring
- Medical Doctor (MD) degree or Pharmacy degree (MSPH, PharmD, PhD, or equivalent) with at least one year of experience as a Clinical Research Associate I; OR a four-year degree in medical, biological, physical, health, pharmacy, or related science with at least two years of clinical research experience; OR a two-year college curriculum/equivalent training (nursing or life science preferred) with two years of experience as a Clinical Research Associate I.
- Strong understanding of clinical research principles, study conduct, and monitoring practices.
- Thorough knowledge of FDA and/or EU regulations, ICH Guidelines, GCP, and applicable local regulatory requirements.
- Experience working with multiple therapeutic areas and applying protocol requirements in a clinical research environment.
- Proficiency with Microsoft Office, IxRS platforms, and electronic data capture (EDC) systems.
- Excellent communication, interpersonal, planning, organization, and problem-solving skills.
- Willingness and ability to travel, with a valid passport and driver's license.
- Proficiency in English and fluency in the local language(s) required within assigned countries of responsibility. 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 - $79,500.00 - $158,500.00 The 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. We love knowing that someone is going to have a better life because of the work we do. To view our other roles, check out our careers page at Discover a world of difference at Worldwide ! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn .