Note: The job is a remote job and is open to candidates in USA. Prevail InfoWorks is a leader in technology-enabled clinical trial services and e-clinical software products for life sciences companies. The Clinical Project Coordinator I supports multiple clinical trials by assisting Project Managers with administrative tasks, site and vendor issues, trial start-up, documentation, submissions, coordination, and project lifecycle activities.
Responsibilities
- Maintain list of study and site contacts as required. Keep contact info up to date
- Manage system access with assigned Project Manager
- Assist with trial start up activities as required
- Help with study plans/documents
- Coordinate functional areas
- Liaison with vendors for study deliverables
- Assist in development, finalization, and approval of trial specific documents
- Assist in completion of trial level templates
- Attend meetings, take minutes, track attendance, provide metrics as requires, update and maintain action items
- Assist with HA/EC submission activities, prepare submission documents as needed/requested
- Assist Safety group with site contact info as needed/verify their recipients list SUA/SUSARs, file any SUA reports
- Assist in distributing missing data reporting, assist in close out activities
- Other responsibilities assigned by Associate Director of Clinical Operations
Skills
- Minimum of a bachelor's degree with a major in science, nursing, or other health related field is required
- Ability to multi-task
- Flexible with change and agile when necessary
- Demonstrated proficiency with all Microsoft Office Tools
- Excellent interpersonal and teamwork skills are imperative
- Must have strong customer service orientation and be a proactive and effective communicator
- Knowledge of basic computer programs such as Word, Excel, Power Point, MS Project, and Visio
- Minimum of (1) one year progressive clinical project experience is desired
- Experience serving as assistant study coordinator, CRA, or clinical trial assistant desired
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