FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
About the role
Key responsibilities & impact- Serve as a floating resource to perform a variety of activities supporting the execution and management of projects and programs
- Provide assistance across Research Operations, Endpoint and Specialty Services, Site Operations, Data Management, Quality Control, and Trial Master File functions based on business needs
- Work with team members to ensure timely completion of deliverables and resolution of issues
- Perform administrative tasks including filing, copying, and preparing shipments for assigned projects
- Upload essential documents into the eTMF system
- Perform quality control reviews of project documentation and support Trial Master File submissions
- Perform ALCOA+ checks of documents uploaded into the eTMF system
- Participate in project, program, functional area, and general CPC meetings as required
- Assist with preparation of Master Plans, Resource Materials, Source Documentation, Meeting Minutes, and Trial Master File submissions
- Coordinate and track receipt of project supplies to study sites
- Track receipt, entry, upload, review, and feedback to investigational sites of endpoint testing
- Assist with development, administration, and tracking of project-specific training
- Manage email reconciliation and export at study close-out
- Collect and review investigational site documentation and process it as directed
- Correspond with investigational sites, CPC staff, and sponsors to resolve data queries and collect outstanding documentation
- Serve as a primary point of contact for investigational sites
- Perform query management, report generation, and data reconciliation tasks
- Assist with User Acceptance Testing (UAT)
- Manage user access requests, including user reconciliation
- Perform general data review of study data in EDCs
Requirements
What you’ll need- GED or HS Diploma required
- Nursing or bachelor’s degree preferred
- Minimum of 1 years of experience working in a clinical research (or similar) setting
- Higher degree may be considered in lieu of experience
- Demonstrated ability to complete core tasks with minimal direction, while reliably escalating for guidance on less routine assignments
- Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials
- Good understanding of the drug development process
- Proficiency in MS Office, particularly spreadsheet databases and word-processing
- Excellent communication and organizational skills
- Great attention to detail
- Ability to work with others in a manner that promotes group effort and achievement
- Ability to shift priorities quickly while ensuring accuracy and timely completion of tasks
- Ability to manage conflicts and resolve problems effectively
- Ability to discern priorities and obtain direction to accomplish day-to-day tasks
Benefits
Comp & perks- Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
- Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)
- 11 paid holidays
- 15 - 25 vacation days based on years of service
- Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)
- Flexible and remote work schedules