Clinical Study Team Assistant I - FSP

Parexel is looking for multiple Clinical Study Team Assistant I in Mexico!

The Clinical Study Team Assistant I (CSTA I) is an essential part of the study team and is responsible for supporting key clinical trial tasks for assigned studies to ensure compliance with timelines, Good Clinical Practice (GCP), and client Standard Operating Procedures (SOPs). The role collaborates with global study team members and is responsible for multiple tasks that span from study start up to study close out which enables the efficient execution of clinical trials to high quality standards.

Key Accountabilities:

• Responsible for providing study level operational support to the study team from study start up to close out and submission

• Maintains and oversees of study team shared spaces

• Trial Master File (TMF) maintenance, compliance, and oversight

o Analyze, interpret, and follow up on metrics

• Maintains and oversees Study Team on Demand (STOD)

o Analyzes, interprets, and follows up on metrics

• Maintains client registries and systems as required to ensure compliance

• Tracks and oversees study information; follows up with functional lines as needed

• Liaises with cross functional study team members:

o Initiates and coordinates the completion of study level forms and data entry into various clinical operations applications and systems

o Provides study level reporting to support management of clinical trial data, clinical trial budget and timelines

• Quality control of essential clinical trial documentation including components of the Clinical Study Report (CSR) and regulatory submission

• Supports engagement of Independent Oversight Committees

• Provides support with audit and inspection readiness activities

• Assists with oversight and tracking of clinical trial budget spend

• Provides logistical and operational support for Investigator Meetings

• Coordinates the translation of documents as required

• Provides status updates on key tasks and contributes to study team meetings

• Provides support to study teams with system setup and maintenance

• May provide support for global study team communications to sites

• Works proactively with minimal oversight to coordinate and prioritize multiple key study tasks in support of clinical trial systems and processes

• Uses established procedures and methodologies to ensure the completion of assigned tasks according to timelines and to required quality standards

Collaboration

• Partners with the Clinical Study Team Lead (CSTL) in providing study level operational leadership and support to clinical study teams.

• Partners with the Global Study Manager and the Study Manager in providing site management, monitoring and vendor operational oversight and support

• Collaborates with global cross functional study team members of varying levels of seniority

Compliance with Parexel standards

• Complies with required training curriculum

• Completes timesheets accurately as required

• Submits expense reports as required

• Updates CV as required

• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Skills:

• Proficient in Microsoft office applications (Outlook, Word, PowerPoint, Excel, TEAMS)

• Effective verbal and written communication skills

• Fluency in written and spoken English required

Knowledge and Experience (preferred):

• Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research

Education:

• Bachelor’s of Art or Bachelor’s of Science with 1-3 years experience

• Master’s of Art, Master’s of Business Administration or Master’s of Science with 0-1 years experience