New · posted Nov 1
Parexel · Pharmaceuticals
Clinical Research Associate II
- Remote, US
- Remote
- Full-time
- Associate & Specialist
The role
The Clinical Research Associate II will act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
Team Development and Support
- Contributes to CRA team knowledge by acting as process Subject Matter Expert, buddy/mentor and sharing best practices as appropriate/required
- Supports and/or leads audits/inspection activities as needed
- Performs co-monitoring visits where appropriate
Compliance with Parexel Standards
- Complies with required training curriculum
- Completes timesheets accurately as required
- Submits expense reports as required
- Updates CV as required
- Maintains a working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements
What you need
Education
- Bachelor’s degree with a strong emphasis in science and /or biology
- Fluent in local languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively
- Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
- Hands on knowledge of Good Documentation Practices
- Proven skills in Site Management including management of site performance and patient recruitment
- Demonstrated high level of monitoring skill with independent professional judgement
- Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices
- Ability to understand and analyze data/metrics and act appropriately
- Capable of managing complex issues, working solution-oriented manner
- Performs root cause analysis and implements preventative and corrective action
- Effective time management, organizational and interpersonal skills, conflict management, problem solving skills
- Able to work highly independently across multiple protocols, sites, and therapy areas
- High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
- Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
- Demonstrates commitment to Customer focus
- Works with high quality and compliance mindset
- Positive mindset, growth mindset, capable of working independently and being self-driven
- Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices
- Ability to travel domestically and internationally approximately 65%-75% of working time
- Expected travelling ~2-3 days/week
- Current driver’s license required
Knowledge and Experience
- Minimum 2 years of direct site monitoring experience in biotech/pharma/CRO
- Note: Specific monitoring and therapeutic area experience requirements may vary depending on the Country or study needs.
What you'll do
Site Management Responsibilities
- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial
- Performs clinical study site management/monitoring activities in compliance with International Conference on Harmonization / Good Clinical Practices, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated Documents
- Gains an in-depth understanding of the study protocol and related procedures
- Coordinates and manages various tasks in collaboration with other sponsor roles to achieve Site Ready
- Participates and provides inputs on site selection and validation activities
- Performs remote and on-site monitoring & oversight activities using various tools to ensure:
- Data generated at site are complete, accurate and unbiased
- Subjects’ right, safety and well-being are protected
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, closeout visits and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance
- Identifies, assesses, and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with Clinical Research Manager and Partner Line Manager
- Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelines
From the posting
About Parexel
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.
Parexel is seeking CRA IIs in the West or Pacific Northwest US!
Equal opportunity, accessibility and legal noticesParexel's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in the US56 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $80,000 | $110,000 | $127,875 |
Comparisons: the base pay employers published on open Clinical Research roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Research
The general path across 193 open Clinical Research roles on Regulatory Jobs, with the titles they carry most. Not Parexel's own promotion track.
Career resources on Clinical Research
Skills DNA
What this role leans on
How many of the posting's 46 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct13
- Documentation and SOPs8
- Collaboration and leadership8
- GMP and compliance6
- Investigations and CAPA2
- Validation and qualification2
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Parexel on Regulatory Jobs
- 47
- Open roles
- 46
- Distinct roles
- 6
- Locations
By discipline
- Clinical28 60%
- Regulatory18 38%
- Quality1 2%
By level
- Senior & Principal31 66%
- Manager10 21%
- Associate & Specialist5 11%
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Clinical Research Associate II at Parexel
Open until filled.