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The Clinical Research Associate II will independently manage and monitor Phase I oncology clinical trial sites from startup through closeout. They are responsible for ensuring protocol compliance, data integrity, and patient safety while maintaining effective relationships with site personnel.
Position
Clinical
Research
Associate
II,
Oncology
Location:
Remote (East
Coast
USA
Preferred)
Salary: $90,000 to $100,000 D.O.E Unfortunately, we cannot support work visa permit applications for this role About Pharmaron Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services. We're proud of the impact we make and just last year, we supported over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,000 global customers. To learn more, visit www.pharmaron.com.
Job
Overview: Pharmaron is seeking an experienced Clinical Research Associate II to support innovative Phase I oncology clinical trials across multiple U.S. sites. In this role, you will lead site monitoring activities from study startup through closeout, ensuring protocol compliance, patient safety, data integrity, and adherence to ICH-GCP and regulatory standards. This is an exciting opportunity to contribute to cutting-edge therapies while partnering closely with investigators, sponsors, and cross-functional clinical teams.
Key
Responsibilities: Independently manage and monitor assigned Phase I oncology clinical trial sites from study startup through closeout. Conduct all required site visits, including Pre-Study Visits (PSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV). Ensure studies are conducted in accordance with approved protocols, ICH-GCP guidelines, sponsor requirements, and applicable regulatory standards. Perform source data verification (SDV), review eCRFs/CRFs, and ensure accuracy, completeness, and timeliness of clinical trial data. Build and maintain effective working relationships with investigators, coordinators, and site personnel. Monitor patient safety processes, including timely review and escalation of adverse event and serious adverse event reporting. Identify site risks, protocol deviations, and operational issues, and drive timely resolution and corrective actions. Maintain inspection readiness through oversight of essential documents, regulatory files, and site compliance activities. Ensure investigational product accountability and proper handling procedures, when applicable. Prepare monitoring reports, follow-up letters, and visit documentation within required timelines. Maintain accurate and current updates in CTMS, eTMF, and other clinical systems. Collaborate cross-functionally with Project Managers, Clinical Trial Managers, and sponsors to communicate site progress and study milestones.
What
We are
Looking for: Bachelor's degree, RN, or equivalent combination of education and relevant experience; life sciences background preferred 3+ years of clinical monitoring experience within sponsor, CRO, or investigative site environments Hands-on oncology monitoring experience required, including Phase I studies Strong knowledge of ICH-GCP guidelines and applicable regulatory requirements Ability and willingness to travel up to 30% based on study needs Excellent organizational skills with strong attention to detail Strong communication skills and ability to manage site relationships effectively Experience using CTMS, EDC, eTMF, and other clinical trial systems Experience in early-phase startup environments Ability to independently prioritize workload across multiple sites and studies Why Pharmaron? Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.
Collaborative
Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.
Benefits
As part of our commitment to your well-being, we offer a comprehensive benefits package: Insurance including Medical, Dental & Vision with significant employer contributions Employer-funded Health Reimbursement Account Healthcare & Dependent Care Flexible Spending Accounts 100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance 401k plan with generous employer match Access to an Employee Assistance Program
How To Apply
Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today! As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences. #LI-MC1
Requirements
Candidates must have a bachelor's degree or equivalent and at least 3 years of clinical monitoring experience. Hands-on experience in oncology and Phase I studies is required, along with strong knowledge of ICH-GCP guidelines.
