Global Clinical Trial Operations Intern

Job Description

Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration. The role will collaborate at local level closely with CRA and CTC.

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 Investigator trial file binder

• Meeting Planning:

  • Organize meetings (create & track study memos/letters/protocols)

  • Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

• Support Local initiatives:

  • Create posters and videos

  • Improvement in local process using technologies such as automation, coding, AI

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

• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.

• Assist site visits as appropriate including but not limited to validation visits, initiation visits, monitoring visits, close-out 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.

• Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.

• Fluent in Local Languages and English (verbal and written) and 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 & country clinical research law & 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 skill and independent professional judgment.

• Good IT skills such as automation, video editing, coding, AI.

• Effective time management, organizational and interpersonal skills, conflict management

• Able to work with other experienced research professions 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 Line Manager.

• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.

• Demonstrates commitment to Customer focus.

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