Clinical Study Team Assistant I (CSTA I)

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Our client is a leading research-based biopharmaceutical company. They apply science and their global resources to deliver innovative therapies that extend and significantly improve lives. Every day, colleagues work across developed and emerging markets to advance wellness, prevention,  treatments and cures that challenge the most feared diseases of our time.

ROLE SUMMARY

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 Pfizer 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.

The CSTA I:

• 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.
• Works proactively with minimal oversight to coordinate and prioritize multiple key study tasks in support of clinical trial systems and processes.
• Collaborates with global cross functional study team members of varying levels of seniority.
• Uses established procedures and methodologies to ensure the completion of assigned tasks according to timelines and to required quality standards.
• Requires fundament​​al knowledge of the principles of the role and applies these skills to achieve assigned tasks

ROLE RESPONSIBILITIES

The CSTA I is responsible for providing study level operational support to the Study Team from study start up to close out and submission including:

• Management and oversight of Study Team shared spaces
• Trial Master File (TMF) maintenance, compliance, and oversight (analyze, interpret, and follow up on metrics)
• Management and oversight of Study Team on Demand (analyze, interpret, and follow up on metrics)
• Maintain Pfizer registries and systems as required to ensure compliance
• Tracking and oversight of study information; follow up with functional lines as needed
• Liaising with cross functional study team members:

• Initiate and coordinate the completion of study level forms and data entry into various clinical operations applications and systems
• Provide 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
• Support engagement of Independent Oversight Committees
• Provide support with audit and inspection readiness activities
• Assist with oversight and tracking of Clinical Trial Budget spend
• Provide logistical and operational support for Investigator Meetings
• Coordinate the translation of documents as required
• Provide status updates on key tasks and contribute to the Study Team Meetings as an active Study Team member
• Provide support to study teams with system setup and maintenance
• May provide support for global study team communications to sites

BASIC QUALIFICATIONS

• 0-3 years exp with BA/BS or 0-1 years exp with MA/MBA/MS
• Proficient in Microsoft office applications (Outlook, Word, PowerPoint, Excel, TEAMS)
• Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research