Clinical Study Team Assistant Job at Parexel

Clinical Study Team Assistant

Parexel

Location:

Category:
Research and Development

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

As a part of the global Project Leadership group at Parexel, you are responsible for leading cross-functional teams to deliver high-quality and patient-focused clinical trials and help bring life-changing treatments to market faster. You collaborate with clients and internal stakeholders to identify project requirements, develop project plans, and manage project timelines and budgets. The role requires strong leadership and communication skills, the ability to work under pressure, and a passion for improving patients' lives.

Job Responsibility:

Provide Client Trial Master File (TMF) support and maintenance – file & ensure documents are in the TMF
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)
Accountable for analyzing, interpreting and evaluating clinical trial documentation to determine appropriateness for inclusion into the TMF
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: Coordinate Clinical Study Agreement approvals to ensure timely site initiation
Responsible for coordinating the clinical trial application to ethics committee and regulatory authority
Responsible for coordinating responses to ethics committees
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
Set up of study in shared space and set up folders as needed
File documents to shared space as requested
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.
Distribute meeting appointments and agendas
Track attendance and/or planned attendance
Prepare agendas and minutes as delegated
Act as central point of contact for team as needed
Distribute study communications as requested (minutes, notifications, etc.)
Participate in study meetings as requested and prepare minutes and actions upon request
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
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
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
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

Requirements:

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

What we offer:

Supportive work environment
High degree of empowerment and accountability
Work with a diverse set of clients and therapeutic areas
Encouraged to take on new challenges and pursue your interests
Supportive and inclusive environment
Flexible work arrangements
Remote, in-office and hybrid roles
Varied project experience
Career progression

Additional Information:

Job Posted:
February 04, 2026

Employment Type:

Fulltime

Work Type:

Remote work

Parexel - All Job Offers

Job Link Share:

Clinical Study Team Assistant

Parexel

Location:

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 04, 2026

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Job Description:

Job Responsibility:

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Additional Information:

Job Posted:February 04, 2026

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