Clinical Project Assistant II
The Clinical Project Assistant II 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 individuals is necessary. Excellent verbal and written communication skills are essential. This position will support the Clinical Project Managers, Clinical Research Associates and Study Team for the management of ongoing clinical studies. The Clinical Project Assistant II position is an integral member of the clinical project team providing support and troubleshooting on various aspects of project.
- Provide clinical project management support for Project Managers, CRAs, and Sponsors to ensure site compliance and study team performance within project timelines.
- Accurately update and maintain study relevant documents such as trackers, meeting minutes and study data to monitor project status.
- Act as a central contact for the clinical sites for designated project communications, correspondence and associated documentation
- Apply knowledge of company policies and regulatory standard practices to resolve problems
- Support 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.
- Set Up study files and maintain records in the Trial Management Systems (TMF, SharePoint, etc.)
- Act as a liaison with partners and vendors with supplies management.
- Support sponsors and Project Manager 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.), including a precise quality check (QC) when documents are received.
- Communicate and 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 assemble, review, and maintain study specific templates and trackers.
- Maintains clinical grant tracking database for each study, generates periodic reports on status of grant payments and resolves payment inquiries from investigator sites.
- Support sites to ensure compliance to study protocol, timelines and regulatory guidelines
- Responsible for creating and completing informed consent form (ICF) checklists for applicable sites and studies as needed
- Responsible for maintaining and tracking all study personnel’s up-to-date training status and information
- Collect and review safety source documents provided by sites.
- Support sites & study team with study related documents/imaging uploads
- Other project support duties as assigned
Multilingual (Language) skills are a plus (especially in Spanish, German, Japanese, Italian or Chinese)
- 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 other related field is expected.
- A minimum of one year experience in the clinical research industry
- 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
- Self-starter, committed to finishing projects completely while meeting project deadlines
- Ability to handle multiple responsibilities and work well under pressure
- High attention to detail and level of accuracy
- High degree of tact, judgment and discretion
- Must be prepared to travel at times (domestic and internationally) as needed.