Clinical Trial Associate FSP Clinical

• Establish and maintain the Trial Master File (system or file room) in inspection-ready state

o Communicate directly with sites to drive collection of essential documents from start-up through study closure

o Ensure accurate and timely review and filing of clinical trial related materials

o Perform and support QC reviews of study, country and site files, including issue resolution

o Produce reports and status metrics as requested

• Establish and maintain the Clinical Trial Management System in inspection-ready state

o Maintain accurate and up-to-date site, vendor and internal study team contact information

o Track study progress and produce reports and status metrics as requested

o Assist with Investigational Product reconciliation

• Assist study team by performing administrative tasks as needed

o Schedule and run meetings, both in-house and remote by means of virtual conferencing system

o Prepare meeting agendas, minutes, and track action items

o Operate and navigate within clinical trial systems including but not limited to TMF, CTMS, ECMS, EDC

• May assist with the creation and maintenance of documents and plans for assigned clinical studies including but not limited to training materials, study binders, plans, presentations, and reports

o Ensure timely distribution of clinical trial related materials to sites, study team, field CRAs and vendors

• Under supervision of the Protocol Lead, may assist with the following:

o Perform limited data cleaning activities

o Review Informed Consent documents

o Perform Site/Site Management Organization Regulatory Monitoring

• Assist in preparation and follow-up of company-sponsored site quality audits as well as regulatory authority inspections

Qualifications1+ year of industry experience.

Strong TMF experience.

Oncology experience preferred.

BA/BS preferred.EEO 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.