Clinical Research Associate (CRA) - US Any Region

Parexel; Denver (CO); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Health Insurance

Vision Insurance

Dental Insurance

Tuition Reimbursement

Paid Time Off

Flexible Spending Account

Health Savings Account

Work-Life Balance

401(k) Plan

Pet Insurance

Job summary

Parexel in Denver, CO is seeking a Clinical Research Associate (CRA) with Oncology, Ophthalmology, Metabolic, Hematology or CAR-T monitoring experience to join our team. You will manage clinical sites from start-up through closeout, serving as the primary contact for site teams and ensuring study quality, patient safety, regulatory compliance, and accurate data.

In this on-site role, you will conduct monitoring visits, build site relationships, support enrollment, and collaborate across

Qualifications

• Bachelor's degree in biological sciences, pharmacy, or health-related discipline
• Onsite monitoring experience in clinical trials
• Knowledge of GCP and regulatory requirements
• Experience with CTMS/EDMS and MS Office (Excel, Word)
• Strong written and verbal communication, organizational skills
• Ability to manage multiple priorities and meet timelines

Responsibilities

• Conduct qualification visits, site initiation visits, monitoring visits, and termination visits at assigned sites
• Manage site quality and delivery from site identification through closeout
• Serve as primary point of contact for assigned sites and resolve site issues
• Build effective relationships with investigators and site staff
• Review trial performance and safeguard participant rights and safety
• Develop patient recruitment strategies with sites to support enrollment timelines
• Ensure compliance with SOPs, protocols, and regulatory requirements
• Evaluate data quality and site accountability of investigational products
• Verify site regulatory documentation and perform site document verification

Skills

Site relationship management

Problem-solving

Communication skills

Independent work

Client-focused

Time management

Education

Bachelor's degree in biological sciences or health-related field

Tools

CTMS

EDMS

Microsoft Office

Job description

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 Clinical Research Associate (CRA) with Oncology, Ophthalmology, Metabolic, Hematology or CAR-T monitoring experience to join our team. As a CRA, you will manage clinical sites from identification through closeout, serving as the primary point of contact for site teams and helping ensure study quality, patient safety, regulatory compliance, and accurate clinical data.

You will conduct onsite monitoring activities, build and maintain productive site relationships, address site issues, and support enrollment and study delivery. Parexel provides world-class technology, training tailored to your experience, opportunities to work across therapeutic areas, and pathways for continued growth within clinical research.

Key Responsibilities

• Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV), and termination visits (TV) at assigned clinical sites, and prepare timely visit and contact reports.

• Manage site quality and delivery from site identification through closeout.

• Serve as the primary point of contact for assigned clinical sites, addressing questions and resolving issues to support successful study execution.

• Oversee study integrity and build effective relationships with investigators and site staff.

• Review trial performance at designated sites and help safeguard the rights, safety, and well-being of study participants in accordance with the protocol.

• Develop patient recruitment strategies with clinical sites to support enrollment timelines.

• Ensure compliance with approved standard operating procedures, study protocols and amendments, Good Clinical Practice, and applicable regulatory requirements.

• Evaluate the quality and integrity of reported data, site performance, and investigational product accountability.

• Monitor the completeness and quality of regulatory documentation and perform site document verification.

Candidate Profile

You'll thrive in this role if you bring:

• Strong site relationship management, problem-solving, and communication skills.

• The ability to work independently with urgency and limited oversight.

• A client-focused, flexible approach to assignments and continuous learning.

• The ability to manage multiple priorities, evaluate changing scenarios, apply study protocols, and meet project timelines.

• An ethical, patient-focused approach and strong attention to quality and detail.

• Comfort collaborating within a matrixed team and communicating clearly with internal and external stakeholders.

Required Qualifications

• At least 18 months of direct onsite monitoring experience as a Clinical Research Associate.

• Oncology, Ophthalmology, Metabolic, Hematology or CAR-T clinical trial monitoring experience required.

• Bachelor's degree or equivalent in biological science, pharmacy, or another health-related discipline.

• Knowledge of Good Clinical Practice, applicable regulatory requirements, and clinical trial processes.

• Experience using a Clinical Trial Management System, an Electronic Document Management System, and Microsoft Office applications, including Excel and Word.

• Strong interpersonal, written, verbal, organizational, and problem‑solving skills.

Benefits and Compensation

• Health, Vision & Dental Insurance

• Tuition Reimbursement

• Vacation/Holiday/Sick Time

• Flexible Spending & Health Savings Accounts

• Work/Life Balance

• 401(k) with Company match

• Pet Insurance

For a complete list of benefits, please visit www.parexel.com/us-benefits .

Some roles may be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.

We offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health 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.

#LI-REMOTE

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.