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New · posted Nov 1

Parexel · Pharmaceuticals

Sr. Clinical Research Associate - FSP

  • Remote, US
  • Remote
  • Full-time
  • Senior & Principal
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PayNot published
EmploymentFull-time
LocationRemote, US
LevelSenior & Principal
FunctionClinical Research
DeadlineOpen until filled

The role

Clinical/Scientific and Site Monitoring Risk

  • Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team
  • Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goals
  • Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
  • Drive Quality Event (QE) remediation, when applicable
  • Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable

The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company’s image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial.

What you need

Education

  • Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
  • Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
  • Monitoring Experience: Minimum 2 years relevant experience in clinical research site monitoring
  • Must be fluent in English and in the native language(s) of the country they will work in
  • Ability to travel 60-80%
  • Valid driver’s license and passport required

Skills named in this posting

What you'll do

Monitoring Responsibilities and Study Conduct

  • Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality
  • Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
  • During study conduct, serve as the primary point of contact for assigned investigator sites.  Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
  • Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
  • Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
  • Attend investigator meeting when required (virtual or F2F).  Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators.  Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level
  • Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
  • Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
  • Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
  • Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
  • Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines
  • Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities
  • Support database release as needed
  • May undertake the responsibilities of an unblinded monitor where appropriate
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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 · 47 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 1, 2026

Salary intelligence

How the pay compares

Senior & Principal roles in the US50 roles publishing pay

Middle half $123,750 to $130,500, median $124,500
Annual base pay
Annual base payLowMedianHigh
All US$123,750$124,500$130,500

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.

  1. One step back

    Associate & Specialist

    Often: Clinical Research Associate · Clinical Research Coordinator

    $110K median102 open

  2. This role

    Senior & Principal

    Often: Senior Clinical Research Associate · Sr. CRA

    $125K median87 open

  3. Next step

    Manager

    Often: Associate Clinical Research Manager · Senior Clinical Research Manager

    2 open

  4. Later

    Director

    Often: Associate Director, Site Monitoring · Director, Clinical Trial Liaison

    2 open

Career resources on Clinical Research

Skills DNA

What this role leans on

How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 5 linesLab testing and methods: 1 lineDocumentation and SOPs: 3 linesInvestigations and CAPA: 15 linesClinical trial conduct: 18 linesCollaboration and leadership: 7 linesGMPLab testingDocumentationInvestigationsClinical trialsTeamwork
  • Clinical trial conduct18
  • Investigations and CAPA15
  • Collaboration and leadership7
  • GMP and compliance5
  • Documentation and SOPs3
  • Lab testing and methods1

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.

From Regulatory News

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%
See all 47 Parexel roles

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Sr. Clinical Research Associate - FSP at Parexel

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