Clinical Trial Assistant (AdvancedGroup_409809) Collegeville, Pennsylvania

Job Number: 409809

Clinical Trial Assistant

Position Purpose: 
Provide an overview of the responsibilities of the position by providing a summary of the most
important aspects and duties of the position.
Support the planning and conduct of clinical studies as a member of the study team. Responsible for study
documentation and filing, organizational and logistical support, as well as cost tracking for assigned projects.

Reporting Relationships: 
List other positions in the company that are reporting into this position or that this
position reports into.
Global Clinical Operations Lead, Associate Director
Roles that report to this position
No direct reports

Main Responsibilities and Accountabilities: 
List the roles and responsibilities of the position (please limit the
number of responsibilities to the primary ten.)
1 Trial Master File maintenance and filing of relevant documents according to ICH-GCP and SOPs (as
required), respective archiving and electronic filing of documents.
2 Assistance with the preparation/collection of all study documents (e.g. protocol, CRF, forms, manuals,
etc.) and presentation materials.
3 Support with study start up activities (e.g. review of study specific documents provided by CRO,
participation in User Acceptance Testing, etc.).
4 Support with tracking timelines/deliverables.
5 Track various program-related activities/documents such as project team calendars, monitoring
frequency, IMPACT reports and others. Periodically distribute tracking documents to predetermined
contacts.
6 Assist with cost tracking of all expenses, invoices, support budget and forecast planning.
7 Support with the organization of internal and external meetings and attendance as required; prepare
minutes as required
8 Assist Study Team by acting as a back up for receiving and triaging calls from investigator sites, CPLs,
Medical Monitor, third party vendors and any other appropriate members of project team.
9 Provide logistical support for the shipping of study specific documents/material.
10 Assist with regulatory submission preparations.
11 Assist Study team members with any additional administrative or project related tasks, as requested.
 
Knowledge of ICH- GCP and SOPs in Clinical R&D
2-5 years experience in related area
Competencies
Excellent planning, coordination, and time management skills to meet deadlines
Demonstrated attention to detail
Strong written and oral communication skills and a high level of interpersonal and
organizational skills
Proficient language skills (English fluent in writing and speaking) as well as computer
skills (e.g. Microsoft Word, Excel, and PowerPoint)

 

Interested candidates please send resume in Word format to ksantilli@advancedclinical.com Please reference job code 409809 when responding to this ad.