Clinical Trials Associate (FSP)

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Job description

*Job Description*

Assist clinical study teams in the execution of clinical trials. Primary responsibilities may include establishing and maintaining the Trial Master File (electronic [eTMF] or paper TMF) and Clinical Trial Management System (CTMS) in an inspection-ready state, reviewing and tracking essential documents throughout the life of the trial, and assisting with production and distribution of study materials and site communications.
Organizational Relationships:
• Reports to ExecuPharm (EP) Line Manager with day-to-day direction from the Client.
• Liaises with cross functional lines as appropriate.
Primary Duties:
• 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 CTMS 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 (document repositories), EDC (Electronic Data Capture)
• 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 Clinical Research Associates (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
• Works under general supervision in performing regular job duties and receives general instructions on new assignments
• Primarily works and collaborates with Protocol Lead, internal and external study staff, vendor staff, and peers
• Adhere to CFR, GCP/ICH, Clinical Development Operations and project-specific quality documents (e.g., SOPs, work practices, training guides)
• Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training.
• Adheres to EP and Client SOPs and processes.*Qualifications*

BS/BA or equivalent experience preferred
• A minimum of 1-year clinical trial experience, preferably within the pharmaceutical or biotechnology industry
• Basic knowledge and understanding of Essential Documents, CFR and GCP/ICH
• Proficiency with technological systems (Microsoft Office, TMF, CTMS, EDC, ECMS, Zoom)
• Fundamental understanding of filing systems and organizational tools*Why Work at Parexel*

*There are pivotal moments in every career:* Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.