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Parexel

End-to-end clinical trials and regulatory consulting

Clinical Research Associate

Clinical Research OperationsUpdated on Nov 11
Full-timeRemote in USANo salary listed

About the Job

Requirements

  • At least 12 months of direct onsite monitoring experience as a Clinical Research Associate.
  • A 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.
  • Ability to work independently with urgency and limited oversight.
  • Ability to manage multiple priorities, evaluate changing scenarios, apply study protocols, and meet project timelines.
  • 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.

Responsibilities

  • Conduct qualification visits, site initiation visits, monitoring visits, and termination visits 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.

Desired Qualifications

  • Oncology, Ophthalmology, CAR-T, and/or MASH clinical trial monitoring experience.

About the Company

Parexel

End-to-end clinical trials and regulatory consulting

Parexel provides end-to-end clinical development services for pharmaceutical, biotechnology, and medical device clients from Phase I to Phase IV. Its offerings include clinical trial management, regulatory consulting, and biostatistical analysis to support the design, execution, and analysis of clinical studies. The company operates as a CRO, partnering with sponsors to manage trials, ensure regulatory compliance, and generate robust data for drug development. What sets Parexel apart is its breadth of services across the trial lifecycle, emphasis on quality and reliability, and industry recognition, along with a focus on patient-centric approaches and leadership in gender partnership. The company’s goal is to help clients bring new therapies to market efficiently and safely by delivering high-quality, compliant trial outcomes and data that support regulatory submissions.

Company size
10,001+
Company stage
Acquired
Total funding
$8.5B
Headquarters
Durham, NC
Founded
1982

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