Clinical Trial Assistant (FSP)

Major Duties of CTA:

Support the tasks below for assigned project throughout the study:

• Study Start-Up

o Supports and coordinates the clinical trial application to ethics committee and regulatory authority, if applicable, to obtain approval within required timeline.

o Coordinates and applies for export/import license of, lab kits, equipments, and specimen, if applicable.

o Supports for preparation of site initiation packages (e.g. SMF)

o Organizes investigator meeting

• Study Conduct

o Supports and coordinates the clinical trial application for amendment and progress report to ethics committee and regulatory authority, if applicable, and obtain approval within required timeline.

o Maintains / develops local tracking spreadsheets for study-related documents, data, tasks and activities, as applicable.

o Assists CRA for the responsibility of tracking, distribution and filing of clinical trial documents/information (e.g. SUSAR, paper CRFs, DCFs ) with quality review for accuracy and completeness.

• Study Close-Out

o Ensures along with the CRA the reconciliation of Trial Master File and the Site Master File

o Supports SM and CRA for final archive of study-related documents

o Ensures study payment completion.

Other responsibilities of the CTA:

• Supports SMs/CTA lead for quality improve related initiatives

• Assists in preparation of newsletters and other study-related documents.

• Complies with Pfizer Policies, SOPs & IGs and local regulations during various projects related transactions

• Takes SME role and provides training to CRA/SM regularly.

• Ensures P2L and QCB Metrics Compliance pertaining to CTA role.

• Provides back-up coverage for other CTAs as necessary.

• Mentors new CTA when applicable (apply for B4 level)

• Supports CTA Lead for production and tracking of trial metrics measurements.

• Supports SM for coordinating with sites for finalizing budget worksheets and contractual agreements (e.g. FCPA clauses).

• Maintains and ensures the availability of inventory for all non drug supplies.

• Provides logistic and administrative support to project teams.

• Assists on SUSAR package preparation for Ethics Committee and regulatory authority, if applicable.

• Demonstrates and promotes Pfizer global value system across all interactions.

Qualifications:

• College degree or above, University Graduate preferred

• Science Background preferred

• Good English skills in writing and reading

• Proficiency in basic computer literacy (e.g. Microsoft word, Excel and PowerPoint)

• Knowledge of ICH GCP and local regulations preferred

• Experience in clinical trial administration preferred

• Experience in management of clinical trial and/or regulatory documents preferred

• Knowledge of application used in the clinical trials preferred

Technical Competencies:

1. Concern for Quality and Compliance

• Understand the quality expectations and emphasis on right first time. Demonstrate 100% compliance with allapplicable company, regulatory and country requirements.

2. Organizational skills

• Work independently and also as a team member. Receives instruction primarily on unusual situation. Ability to organize tasks, time and priorities, ability to multi-task

3. Scientific/technical/administrative excellence

• Understand basic medical terminology, GCP requirements and proficient in computer operations.

4. SOP Compliance

• Maintain knowledge and expertise on all relevant SOPs.

5. Communication and presentation skills

• Ability to communicate effectively and appropriately with internal and external stakeholders.

6. Operational skills

• Expertise in the current role and ability to handle more challenging tasks / role in a clinical trial.

7. Administrative excellence

• Attention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc.

Behavioral Competencies:

1. Interpersonal communications

• Displays sensitivity to manage relationships and ability to build collaborative working relationships withcolleagues and associates both within and external to the organization

2. Influencing

• Demonstrated ability to introduce new ideas and drive the implementation.

• Effectively overcoming barriers encountered during the implementation of new processes and systems

3. Teamwork

• Is visible and well recognized across the Area for promoting collaboration across functional and geographicboundaries

4. Learning organization

• Seeks to clarify feedback non defensively to understand required improvement.

5. Customer Focus

• Identifies and builds effective relationships with customers and other stakeholders.

6. Cultural awareness and sensitivity

• Work well across country and area boundaries, respecting communication and cultural differences in interpersonal relationships.