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.
- 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
- 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