Global Clinical Trial Operations Intern

Job Summary

Under the oversight of the line manager, this role is responsible for comprehensive trial and site administration. The role collaborates locally with the CRA and CTC.

Responsibilities

Responsibilities include, but are not limited to:

• Trial and site administration:
  • Track (e.g., essential documents) and report (e.g., Safety Reports).
  • Ensure collation and distribution of study tools and documents.
  • Update clinical trial databases (CTMS) and trackers.
• Document management:
  • Prepare documents and correspondence.
  • Collate, distribute/ship, and archive clinical documents (e.g., eTMF).
  • Assist with eTMF reconciliation.
  • Prepare the Investigator trial file binder.
• Meeting planning:
  • Organize meetings (create and track study memos/letters/protocols).
  • Support local investigator meetings, including invitations, preparation of materials, venue selection, and support for vendors where applicable.
• Support local initiatives:
  • Create posters and videos.
  • Improve local processes using technologies such as automation, coding, and AI.

Site Management Support (as appropriate)

With oversight of Sr. CRA/CRA and/or CRA Manager, support site management as appropriate, including but not limited to:

• Coordinates and manages various tasks in collaboration with other sponsor roles to achieve “Site Ready.”
• Assists with site visits as appropriate, including but not limited to:
  • Validation visits
  • Initiation visits
  • Monitoring visits
  • Close-out visits
  Ensures visit and non-visit contact reports are clear, comprehensive, accurate, and submitted in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance, and study close-out.
• Manages and maintains information and documentation in CTMS, eTMF, and other systems as appropriate and per timelines.

Competency Expectations

• Fluent in local languages and English (verbal and written) with excellent communication skills, including the ability to understand technical information; developing ability to present technical information with support.
• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH, and country clinical research laws and guidelines.
• Good understanding of global, country/regional clinical research guidelines and ability to work within these guidelines.
• Knowledge of Good Documentation Practices.
• Understanding and developing skills in Site Management, including management of site performance and patient recruitment.
• Developing level of monitoring skills and independent professional judgment.
• Good IT skills, such as automation, video editing, coding, and AI.

Behavioral Expectations

• Effective time management, organizational and interpersonal skills, and conflict management.
• Able to work with other experienced research professionals to develop skills 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, with support from the line manager.
• Works effectively in a matrix multicultural environment; ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to customer focus.

Required Skills

• Competency management
• Conflict management
• Cultural awareness
• Customer centricity / customer-focused mindset
• Database management
• Data documentation
• Data entry
• Decision making
• Document management
• Email management
• Event planning
• File management
• Inventory management
• Line management
• Matrix management
• Meeting facilitation
• Meeting management and organization
• Minute taking
• Multitasking
• Office management
• On-site management
• Payment handling

Additional Information

• Employee Status: Intern/Co-op (Fixed Term)
• Work Arrangement: Hybrid
• Job Posting End Date: 12/30/2026
• Relocation: Not specified
• VISA Sponsorship: Not specified
• Travel Requirements: Not specified
• Shift: Not specified
• Valid Driving License: Not specified
• Hazardous Material(s): Not specified