Senior Clinical Research Associate I/II - Sponsor Dedicated - Oncology Experience Needed

Remote Worker LTD.; United States; Remote; USD 90,000 - 130,000; Full time

Benefits offered by this job

Car or Car Allowance

Medical & Dental Insurance

Life Assurance

Pension

Critical Illness Insurance & Health6

Job summary

Parexel is seeking Senior CRA I/II to join our remote FSP team, supporting oncology studies with sponsor partnerships, ensuring data integrity and regulatory compliance.

You will monitor sites across the trial lifecycle, drive enrollment, and collaborate with cross functional teams; both virtual and onsite monitoring.

The role offers exposure to high visibility oncology programs and opportunities to influence study delivery while traveling up to 75% and working remotely.

Qualifications

• Bachelor's degree or RN required.
• Minimum of 5 years oncology clinical research experience.
• Experience as a clinical monitor both virtual and onsite.
• Strong knowledge of ICH GCP guidelines and trial regulations.
• Experience with CTMS and clinical trial systems.
• Excellent communication, organizational, and problem solving skills.
• Ability to travel up to 75%.
• Fluency in English.

Responsibilities

• Lead monitoring activities for assigned oncology sites per plan and regulations.
• Support site initiation and activation activities, including documentation and training.
• Drive site recruitment and enrollment by maintaining site communications.
• Ensure protocol and regulatory compliance across study conduct and closeout.
• Conduct onsite and remote visits, DS/SDV to ensure data quality.
• Identify and help resolve protocol deviations and data queries.
• Maintain site regulatory docs, files, and training records.
• Liaise with site personnel and study teams to support study objectives.

Skills

Clinical monitoring

Oncology clinical research

Site management

CTMS proficiency

English proficiency

Study management

Communication skills

Education

Bachelor's degree

Registered Nurse qualification

Tools

CTMS

EDC

eSource systems

Job description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

About Parexel

Parexel is a leading global clinical development partner delivering insights driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart.

About the Role

We are seeking a number of Senior Clinical Research Associate I’s & II’s (Senior CRA I & II) to join our Functional Service Provider (FSP) team in a remote capacity. In this role, you will partner with a dedicated sponsor to support the successful delivery of oncology clinical trials, ensuring data integrity, patient safety, regulatory compliance, and operational excellence across assigned investigative sites.

As a study level clinical monitoring professional, you will manage assigned protocols and investigative sites throughout the clinical trial lifecycle, from site activation through study closeout. Working collaboratively with site personnel, study teams, and cross functional stakeholders, you will help drive enrollment goals, support protocol compliance, oversee data quality, and contribute to the efficient execution of studies that have the potential to improve patient outcomes.

This position offers the opportunity to work on complex oncology studies in a high visibility environment while developing strong site partnerships and influencing study delivery through both virtual and onsite monitoring activities. You will be part of a team committed to advancing clinical research excellence and accelerating the development of innovative therapies for patients worldwide.

Key Responsibilities

• Lead monitoring activities for assigned oncology clinical trial sites in accordance with the Clinical Monitoring Plan and applicable regulatory requirements.
• Support site initiation and activation activities, including training, collection of essential documentation, system access readiness, and preparation for first subject first visit.
• Drive site recruitment and enrollment support activities by maintaining regular communication with investigator sites and addressing recruitment challenges.
• Ensure compliance with protocol requirements, ICH GCP guidelines, local regulations, and sponsor processes throughout study conduct and closeout.
• Conduct onsite and remote monitoring visits, source document review, and source data verification to ensure clinical data accuracy, completeness, and quality.
• Identify, communicate, and help resolve protocol deviations, data queries, safety related concerns, and site performance issues, escalating significant risks when appropriate.
• Review investigational product accountability, storage, security, reconciliation, and dispensing activities in accordance with study requirements.
• Maintain site regulatory documentation and ensure site files, study records, delegation logs, and training documentation remain complete and current.
• Serve as the primary liaison for site personnel, supporting study related questions and facilitating communication with study teams and stakeholders.
• Support audit readiness activities, contribute to risk mitigation efforts, and help ensure achievement of study milestones, data review deliverables, and database lock timelines.
• Support decentralized trial capabilities and study technologies at the site level while promoting monitoring best practices and operational efficiencies.
• Build and maintain strong investigator relationships throughout the study lifecycle and perform closeout visits as assigned.

Candidate Profile

You’ll thrive in this role if you bring:

• Strong clinical monitoring, site management, and relationship building capabilities.
• Experience working within clinical research and regulated healthcare environments.
• The ability to collaborate effectively with investigator sites, sponsors, and cross functional study teams.
• A patient focused mindset with exceptional attention to detail and commitment to quality.
• Confidence working with clinical trial technologies, tracking systems, CTMS platforms, and study management processes.
• Strong written, verbal, presentation, and interpersonal communication skills.
• Adaptability, problem solving ability, and a proactive approach to delivering study objectives in a changing environment.

Required Qualifications

• Bachelor's degree, Registered Nurse qualification, or an equivalent combination of education, training, and experience.
• Minimum of 5 years of oncology clinical research experience, including experience as a clinical monitor with demonstrated virtual and onsite monitoring experience.
• Demonstrated experience managing oncology clinical trial protocols.
• Strong knowledge of ICH GCP guidelines, clinical trial regulations, and clinical research processes.
• Experience using CTMS and other clinical trial systems and technologies.
• Excellent communication, organizational, and problem solving skills.
• Ability to travel up to 75% as required.
• Working proficiency in English.

Preferred Qualifications

• Additional education or professional training in a life sciences, nursing, or related discipline.
• Extensive experience across oncology clinical development programs.
• Familiarity with site technologies and platforms such as EDC, electronic investigator systems, and decentralized clinical trial solutions.
• Proficiency in the local language.

Benefits and Compensation

• Car or Car Allowance
• Medical & Dental Insurance
• Life Assurance
• Pension
• Critical Illness Insurance & Health Screenings

We offer a comprehensive benefits package to eligible employees, which includes, life assurance, medical and dental insurance, and additional benefit offerings in accordance with the terms of our applicable plans.

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.