Project Management Assistant

Parexel International Corporation

Baltimore, Maryland

Project Management

-Coordinate with Project Manager or Clinical Lead to complete IRB/EC

submissions and maintain IRB correspondence according to IRB guidelines and


-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).

• Support communications among 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


• 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.

• Schedule teleconferences and meetings as requested.

• Order meals, taxi, etc. and prepare for internal and external visitors as needed.

• Monitor the front desk during am hours and as required for client visits/visitors.

• Copy assigned PM on all correspondence for a project.

• Maintain, track and archive documents within PM department and as required for the


• Support and coordinate contract review/signature process with the PAREXEL

contract team.

• Support other members of Project Management group as needed.

• Foster team environment by assisting other team members with questions and

sharing tools/ideas.

• Request clarification as needed on assigned tasks and provide frequent updates and


Any other duties as assigned.QualificationsSkills:

• 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:

• 1-2 years in a similar administrative position or work experience in other clinical research roles preferred


• 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.

2020-06-20 01:01:18

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