At Parexel FSP, you will be joining a team with a wide variety of experiences and knowledge. We’re looking for people like you to take the initiative to do things better and smarter people who want to grow personally and professionally. We recognize and uphold the importance of all people, the way we do things, our quest for innovation, and most importantly, our patients.
We are looking for a Clinical Study Team Assistant (Project Specialist) 100% home based in Poland, Serbia or Romania.
Your tasks will be
• Provide Client Trial Master File (TMF) support and maintenance – file & ensure documents are in the TMF
o Input into the set- up of TMF document list and maintains relevant clinical trial documents according to International Conference on Harmonization-Good Clinical Practices (ICH-GCP) and Standard Operation Procedures (SOPs), including archiving and electronic filing of documents (TMF)
o Accountable for analyzing, interpreting and evaluating clinical trial documentation to determine appropriateness for inclusion into the TMF
o Evaluate TMF compliance and raise findings to Study Manager (SM)
▪ Files and tracks documents for the study in collaboration with the document owner
▪ Collaborates with the TMF Study Owner for issues or problems to be addressed and to create and manage placeholders
▪ Ensures resolution of Quality Control (QC) findings (as delegated) to support final archive of the clinical study documents
• Maintain, verify, process, and makes updates to Client systems (including Registry), spreadsheets/documents as needed
• For Early Development and some small/single country studies may be required to:
o Coordinate Clinical Study Agreement approvals to ensure timely site initiation
o Responsible for coordinating the clinical trial application to ethics committee and regulatory authority
o Responsible for coordinating responses to ethics committees
o Responsible for coordination of lab kits, equipment and specimens
• Responsible for preparation of site supportive material (e.g. Site binders, Site Master File (SMF))
• Maintain and ensure the availability of inventory for all non-drug supplies, if required
• Ensure organization and maintenance of shared spaces (SharePoint, eRooms, etc.) for the study team
o Set up of study in shared space and set up folders as needed
o File documents to shared space as requested
o Review shared space to ensure others are updating tracking and files as requested by the team
• Support meeting planning and organization (including Investigator Meetings) to ensure regulatory requirements are met and planned within budget
Organize meeting rooms, teleconference information and equipment, meals, site access for external colleagues, etc.
o Distribute meeting appointments and agendas
o Track attendance and/or planned attendance
o Prepare agendas and minutes as delegated
• Act as central point of contact for team as needed
o Distribute study communications as requested (minutes, notifications, etc.)
o Participate in study meetings as requested and prepare minutes and actions upon request
o Set up meetings and WebEx’s as requested
▪ Meetings with internal Client team members
▪ Meetings with CRO and/or vendors
• Confirm information for ENGAGE system is appropriately entered
o Used for engagements related to clinical development such as Data Monitoring Committees (DMCs), Steering Committees, studies under a Clinical Trial Budget (CTB), clinical consultants, publications, etc.
• Works with clinicians and statisticians to maintain Data Monitoring Committee (DMC) checklists, Statistical Analysis Plans (SAPs), Blind Data Review (BDR) decision logs
o Ensures contracts are in place and compliant with Sunshine and Foreign Corrupt Policy Act (FCPA) rules
• Maintain Clinical Pharmacology documents and bioanalytical documents for clinical drug and biomarker assays
• Generate Purchase Orders
• Maintain the registry and/or Clinical Trial Management system(s), as delegated
• Independently manage conflicting priorities to ensure excellent support to multiple project teams; this requires negotiating with customers and/or other team members; provides direction to other service groups
• Identify and implement process improvements (e.g. lessons learned, effectiveness through efficiency, Quality Services & Oversight site and systems audits) for inspection readiness, TMF compliance, Investigator Meeting organization
General
• Complete training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, system, and process related training
• Adhere to EP and Client SOPs and processes
From you we expect:
• Bachelor’s Degree (B.S. or B.A.) in either a Scientific or Business-related field preferred or equivalent relevant experience
• Minimum 2 - 3 years experience in clinical administration in pharmaceutical or clinical research environment
• Solid experience in TMF
• Experience in WORD, EXCEL, PowerPoint, other software and system.
• Fundamental understanding of filing systems and organizational tools
• Proficiency in written and spoken English
• Able to independently prioritize multiple key activities, collaborate effectively with various levels of seniority on the study team and across the organization and efficiently ensure completion of tasks per timelines to required quality standards
• Able to work independently and proactively to anticipate team needs related to clinical trial services.
• Demonstrated effectiveness working with multiple functions in a professional manner
• Effective verbal and written communication skills relating to colleagues and associates both inside and outside the organization
• Evidence of strong attention to detail and interpersonal skills
• Understanding of Food and Drug Administration (FDA), ICH and GCP as well as clinical trials
Join a global community where you can transform your career into a life-changing achievement.
Apply directly or contact us via email at marta.kuniewicz@parexel.com
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