Regulatory Jobs
Hero Gradient Background
A Parexel colleague smiling as she works at her laptop in a bright office
Parexel logo

New · posted Nov 4

Parexel · Pharmaceuticals

Clinical Research Associate II (US West) - FSP

  • Remote, US
  • Remote
  • Full-time
  • Associate & Specialist
Save
EmploymentFull-time
LocationRemote, US
DeadlineOpen until filled

The role

The Clinical Research Associate acts as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility for the 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 preferred 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

Knowledge and Experience

  • Minimum 2 years of direct site monitoring experience in bio/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
Two Parexel colleagues talking and smiling as they walk past the colorful With Heart wall in the office

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 company page · 49 open roles
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 4, 2026

Salary intelligence

How the pay compares

Associate & Specialist roles in the US66 roles publishing pay

Middle half $92,750 to $125,000, median $102,500
Annual base pay
Annual base payLowMedianHigh
All US$92,750$102,500$125,000

Comparisons: the base pay employers published on open Clinical Research roles at the same level on Regulatory Jobs, November 4, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Clinical Research

The general path across 218 open Clinical Research roles on Regulatory Jobs, with the titles they carry most. Not Parexel's own promotion track.

  1. This role

    Associate & Specialist

    Often: Clinical Research Associate · Clinical Research Coordinator

    $103K median118 open
  2. Next step

    Senior & Principal

    Often: Senior Clinical Research Associate · Sr. CRA

    $125K median96 open
  3. Later

    Manager

    Often: Associate Clinical Research Manager · Senior Clinical Research Manager

  4. Later

    Director

    Often: Associate Director, Site Monitoring · US Director of Clinical Site Monitoring and Oversight

Skills DNA

What this role leans on

How many of the posting's 43 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 6 linesDocumentation and SOPs: 8 linesInvestigations and CAPA: 2 linesValidation and qualification: 2 linesData and digital systems: 1 lineClinical trial conduct: 13 linesCollaboration and leadership: 8 linesGMPDocumentationInvestigationsValidationData systemsClinical trialsTeamwork
  • 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, regulations and standards behind this role

The regulations, guidance and standards that govern Clinical Research work in pharmaceuticals, led by the one this posting names, each linked to the agency or standards body that publishes it.

Company hiring pulse

Parexel on Regulatory Jobs

49
Open roles
48
Distinct roles
6
Locations

By discipline

  • Clinical30 61%
  • Regulatory18 37%
  • Quality1 2%

By level

  • Senior & Principal31 63%
  • Manager11 22%
  • Associate & Specialist6 12%
See all 49 Parexel roles

More roles at Parexel

All 49 Parexel roles

Similar Clinical Research roles elsewhere

Clinical Research Associate II (US West) - FSP at Parexel

Open until filled.

Job alerts