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Clinical Operations Intern I

Company: ACS Solutions
Location: Sacramento
Posted on: June 25, 2022

Job Description:

Clinical Operations Intern ICity: EmeryvilleState: CAHours per Week: 40.00Job Category: Clinical Operations**Can be remote, but must be available to report to one of main hubs in the event of audit/special projects** (San Mateo, Emeryville, Cambridge, Ridgefield)Duties:General Description: 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 Essential Functions of the job: 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 maintenanceSkills: Computer Skills: Proficient in MS Office and Zoom Other Qualifications: Interest in learning new skills and a positive attitude. Ability to work in a dynamic and fast-paced environment where priorities may shift and change often. Team-oriented with strong organizational, communication, and problem-solving skills. Demonstrated ability to relate well with and work within diverse teams. Ability to learn and work with different system applications (Veeva, CTMS, SharePoint).Education: Education Required: Bachelor's degree in a scientific or healthcare discipline and at least 6 months of relevant Clinical Operations experience preferred.

Keywords: ACS Solutions, Sacramento , Clinical Operations Intern I, Other , Sacramento, California

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