Clinical Operations Intern I
Company: ACS Solutions
Location: Sacramento
Posted on: June 25, 2022
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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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