Sr. Project Management Assistant
Parexel International Corporation
~~Job Purpose: The Sr. Project Assistant will provide project support to the Project Management department, inclusive of direct sponsor support, TMF setup and personnel training. The ability to maintain confidentiality and to work independently with minimal supervision in a fast-paced environment is required.
•Coordinate with Project Manager or Clinical Lead to complete IRB/EC submissions and maintain IRB correspondence according to IRB guidelines and regulations.
•Serve as primary contact and liaison for IRB/EC; inform team members of any new information or modifications which may affect specific responsibilities of team members; report to line managers any anticipated needs or performance issues.
•Support Project Manager in organizing and follow-up of meetings (i.e. technical meetings, internal meetings, sponsor meetings).
•Support communications among sponsor and internal team members with timely and accurate distribution of materials and by maintaining Project Management files and meeting minutes of key meetings as required.
•Assist in preparation and QC of documents as requested by PM.
•Prepare project timelines and team contact lists as requested.
•Manage and coordinate client survey process.
•Manage and coordinate clinical trial insurance process.
•Manage and coordinate archival process.
Serve as backup point of contact for PM or Clinical Lead communications
•Prepares and maintains regulatory documents including but not limited to the FDA Form 1572, financial disclosures and protocol review forms for all protocols,
•Creation and QC of IRB/EC submission forms including but not limited to preparation of continuing reviews and IRB closeout report.
•Request documents from the IRB as required.
•Ownership of the internal and external regulatory files/Investigator Site Files, including creation, maintenance, and QC processes.
•Maintaining up to date laboratory documents such as CAP, CLIA, and lab director CVs and request updated certificates as required (including filing the updated reports in the Regulatory files).
•Support PM team in the creation, maintenance, and finalization of project documents according to Parexel SOPs and departmental policies
•Compose professional business correspondence for the PM team, clients and outside vendors (including but not limited to check requests, reports, memos, meeting minutes, and letters).
•Prompt preparation and filing of invoices.
•Ordering through ARIBA including ordering and maintaining office supplies as necessary.
•Coordinate ordering/shipping/ receiving of special equipment and supplies as necessary for projects.
•Request Help Desk tickets as requested by the PM.
•Coordinate all incoming and outgoing communications (including daily checks of the fax machine and FedEx/UPS boxes) for the project and develop appropriate systems (i.e. follow-up systems, tracking).
•Schedule and prepare for monitoring and sponsor visits in advance (including QC of Regulatory binder prior to each monitoring visit and assisting monitor during the monitoring visit).
•Maintain monitoring rooms including daily checks at the end of the day to ensure all binders and documents are returned to the PM or coordinators.
•Reserve monitoring rooms and conference rooms as requested by the PM; maintain monitoring room and conference room calendar.
•Creation, maintenance, and submission of study meal requests.
•Book travel and prepare expense reports as needed.
•Comprehensive knowledge of relevant software: Microsoft Windows Operating System and the MS Office Suite including Word, Excel, Outlook, and PowerPoint.
•Excellent oral and written communication skills.
•Highly organized with the ability to manage multiple conflicting deadlines and competing priorities.
•Ability to work in a fast paced environment with minimal supervision.
•Experience in dealing with confidential materials.
•Ability to liaise with senior management within Parexel
Knowledge and Experience:
•At least 2-3 years in a similar administrative position or work experience in clinical research role such as a study technician or entry level coordinator
•High school diploma or equivalent.
•College degree preferredEEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.