Clinical Project Assistant I
The Clinical Project Assistant I role is an entry level position to the clinical research industry. This role requires organizational skills with a high attention for detail. The ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple projects is necessary. Excellent verbal and written communication skills are essential. This position will support the Clinical Project Assistants II/Senior Clinical Project Assistants, Clinical Project Managers, Clinical Research Associates and other Study Team Members as a supporting role for ongoing clinical studies. The Clinical Project Assistant I position is an integral member of the clinical project team providing support and troubleshooting on various aspects of project.
- Assist with updating and maintaining study relevant documents such as trackers, meeting minutes and study data to monitor project status.
- Support clinical sites for designated project communications, correspondence and associated documentation
- Assist Project Managers, CRAs and Sponsors with development, preparation, handling and distribution of Study Supplies (i.e. relevant study binders and packets) and manage distribution status per study.
- Assist with setting up study files and maintain records in the Clinical Trial Management Systems (TMF, SharePoint, etc.)
- Support study team with vendor correspondence and supplies management
- Assist Study Team with distributing, requesting, collecting, and reviewing site regulatory documents for the applicable phase of the clinical study (Study Start Up, Enrollment, Follow-Up, Maintenance, etc.)
- Provide updates to study team as necessary on all aspects of the study (including but not limited to collection of regulatory documents, institutional review board (IRB)/ ethics committee (EC) submissions, follow up visit reminders, study close outs, etc.)
- Coordinate study materials and assist with creating study specific templates and trackers
- Assist with preparation of investigator grant payment requests and corresponding cover letters for distribution, along with maintaining grant database and resolving payment inquiries from sites
- Aid study team on ensuring sites' compliance to study protocol, timelines and regulatory guidelines
- Support CPA II and Sr. CPA personnel with creating and completing informed consent form (ICF) checklists for applicable sites and studies as needed
- Assist with maintaining and tracking all study personnel’s up-to-date training status and information
- Assist with collection and review of safety source documents provided by sites
- Support sites & study team with study related documents/imaging uploads
- Other project support duties as assigned
- A minimum of an associate degree from a two-year college is required. A bachelor’s degree from a four-year college/university in Business Administration, Life Sciences or another related field is desired.
- One year of clinical research industry experience preferred but not required
- Proficient in Microsoft Office/Windows. Specifically: MS Word, MS Excel, MS PowerPoint and MS Outlook
- Excellent written and verbal communication skills with ability to work in a global environment
- Exemplary time management and organizational skills with high attention to detail and level of accuracy
- Ability to handle multiple responsibilities and work well under pressure
- Multilingual skills are a plus (especially in Spanish, German, Japanese, Italian or Chinese)