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Worldwide Clinical Trials

Contract research organization delivering clinical trials

Senior Clinical Research Associate - Onco/Cns

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeNo salary listed

About the Job

Requirements

  • An MD or Pharmacy qualification (MSPH, PharmD, PhD, equivalent Pharmacy degree, or similar) with at least 3 years of CRA experience; or a minimum four-year college curriculum in medical, biological, physical, health, pharmacy, or another related science with at least 5 years of CRA experience; or a two-year college curriculum or equivalent education/training, preferably a nursing or equivalent life science degree, with at least 7 years of CRA experience.
  • Extensive knowledge of clinical research principles and processes, including FDA and/or EU regulations and directives, ICH Guidelines, local regulatory requirements, and SOPs.
  • Strong therapeutic-area expertise, with a thorough understanding of two to three therapeutic areas sufficient to operate as a Lead CRA where appropriate.
  • Strong communication, interpersonal, planning, organizational, time-management, initiative, and problem-solving skills, and the ability to lead and motivate an assigned team when applicable.
  • Technical proficiency with Microsoft Office, IxRS, and electronic data capture systems.
  • A valid current passport and driving licence, and willingness to travel as required.
  • Proficiency in spoken and written English and fluency in the local languages of countries under responsibility.

Responsibilities

  • Lead site qualification, initiation, interim monitoring, management, and close-out activities, ensuring compliance with protocols, Good Clinical Practice, applicable regulations, and SOPs.
  • Protect patient safety and data integrity by reviewing informed consent and safety information, conducting source document verification, reviewing case report forms, and supporting timely query resolution.
  • Guide sites in protocol adherence, Investigator Site File maintenance, regulatory and ethics documentation, investigational product accountability, and ongoing study requirements.
  • Coordinate CRAs as a Lead CRA on global studies and provide mentoring, training, accompanied visits, and practical guidance to less experienced colleagues and site staff.
  • Partner with Project Management and study teams to evaluate deliverables, study milestones, site performance, and monitoring activities.
  • Develop monitoring plans, study-specific tools, templates, and training materials as requested to support consistent study delivery.
  • Review site visit reports and provide clear feedback and edits while ensuring relevant site documentation is maintained for filing in the Trial Master File.
  • Contribute clinical monitoring expertise to study team and investigator meetings, bid defenses, and the design of protocols and case report forms.

Desired Qualifications

  • Experience in full-service monitoring.

About the Company

Worldwide Clinical Trials

Contract research organization delivering clinical trials

Worldwide Clinical Trials is a contract research organization that provides drug development services for pharmaceutical and biotech companies, focusing on running clinical trials to bring new medicines to market. Its core work centers on the science and logistics of clinical trials—designing studies, coordinating sites and investigators, and managing data and regulatory processes to advance drug candidates through development. The company differentiates itself through its specialized, science-driven approach and global expansion achieved via strategic acquisitions, building a larger network and broader capabilities to support complex trial programs. After a history of ownership changes, including a re-launch in 2007 and a majority stake sale in 2023, the firm aims to grow further under new ownership while continuing to offer focused clinical trial services that support medical advancement.

Company size
1,001-5,000
Company stage
Acquired
Total funding
Not listed
Headquarters
Morrisville, NC
Founded
1986

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