Study Start Up Support Associate - Now Hiring

Description:

The Actalent Services Study Start Up Clinical Support Associate (SSU CSA) assists in the coordination and administration of site start up for assigned studies. SSU CSA ensures quality and consistency of site activation deliverables to time, cost and quality objectives.

SSU CSA is responsible for ensuring vendor spreadsheets are completed correctly and processed (submitted to vendor or global team) according to study team guidelines. SSU CSA is responsible for reviewing and processing all sub Investigator documents. SSU CSA will attend weekly Study Team meetings to report on vendor spreadsheets, sub I document progression, etc. All responsibilities are performed according to Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations.

A SSU CSA with longer tenure and experience may take on additional responsibilities from the SSU Manager.

• Assist SSU Manager with obtaining and maintaining essential documents in compliance with ICH-GCP, Procedural Documents.

• Review and process start up documents, including Sub Investigator’s documents in compliance with ICH-GCP, Procedural Documents

• Coordinates with SSU Manager for delivery of regulatory documents at the sites. Proactively identify delays in start-up activities and the risks to the activation plan.

• Attend weekly study team meetings and be prepared to provide a report on vendor spreadsheet status and sub I document status.

• Update Veeva Clinical Vault and other systems with data from centres as required per SSU process.

• Set-up, populate and accurately maintain information in tracking and communication tools (e.g. Veeva, Box, etc.) and support others in the usage of these systems

• SSU CSA is responsible for ensuring vendor spreadsheets are completed correctly and processed (submitted to vendor or global team) according to study team guidelines.

Skills:

GCP, Veeva, Regulatory Documents, Start-up, Activation, Regulatory Binders, TMF, Sharepoint, Site Activation, Site Initiation, QC Documents, ICF, Client support, Microsoft office

Top Skills Details:

GCP, Veeva, Regulatory Documents, Start-up, Activation, Regulatory Binders, TMF, Sharepoint, Site Activation, Site Initiation, QC Documents

Additional Skills & Qualifications:

Must Haves:

• Level of education that supports Skills and Capabilities of the position and ensures successful conduct of accountabilities/responsibilities and appropriate interactions with internal/external customers, completed high school and further studies in administration.

• Previous administrative experience

• Proven organizational and administrative skills

• Computer proficiency

• Very good knowledge of spoken and written English

• Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities

• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities

• Reg. documents review experience

• Veeva ( eTMF required; CTMS preferred)

• Vendors management- Familiarity with working with central vendors to set up EDC (RAVE), Lab supplies (Covance), IVRS (Parexel, Signet Health), ePRO devices (ERT), central Imaging, etc.

• Strong verbal & written communication skills

• Organized

Intermediate Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.