MSI Pharma are seeking to fill a position for a Top Biotech Organisation based in the USA. The client is looking for Clinical Operations Intern with Data entry experience.

General Duties:

• Support tasks related to clinical trial study start-up, maintenance, and close-out, including but not limited to working with Clinical Operations study support, start start-up, study management, site management, and compliance teams (i.e., TMF QC and reconciliation, CTMS data entry)
• Supports the Clinical Operations team in executing business goals and initiatives (i.e., workflow development, process improvement, inspection readiness)
• Support the development and implementation of tools to improve and streamline processes required by the internalization of studies.
• Support with drafting and distribution of minutes for staff meetings and role-based forums; maintain meeting topic catalogs for Clinical Operations meetings

Responsibilities:

• Build basic knowledge of clinical trial operations under close direction and guidance.
• Participate in various team trainings and meetings (ex. CTA Forum, CST Meeting) to understand clinical trial operations timelines, requirements and lessons learned
• Learn best practices in clinical operations methodologies, systems, and processes.
• Includes eLMS Training, participation in CTA Forum, shadowing CTAs
• Short term or ad hoc support to project teams:
• Draft agenda and minutes, setup and maintain trackers.
• Create and maintain repositories (i.e., SharePoint)
• Maintain meeting topic catalogs and distribute information to teams.
• Collect and collate data to support process improvement efforts.
• Create surveys and questionnaires with MS Forms
• Ad hoc support of Clinical Operations priority initiatives and projects.
• Provide support within Clinical Operations Americas and other GCO projects, as needed.
• Assigning Clinical Trial Numbers - Maintain tracker and monitor central mailbox
• Confidentiality Disclosure Agreements - Maintain repository and monitor central mailbox
• Confidentiality Disclosure Agreements - Archive and support teams with search
• Document archiving (hardcopy and electronic).
• Support with on-site preparation and tracking prior to off-site storage.
• Support Trial Master File review.
• Content and completeness QC using ALCOA-C and study specific eTMF Management Plan
• eTMF close-out activities
• Complete data entry in Clinical Trial Management System.
• Support with ad hoc data entry and maintenance

This position can be remote, but will require travel to sites during audits and special projects