Job Description

Job Responsibilities:

1. Major Duties of CTA:

• Support the tasks below for assigned project throughout the study:
• Requests payments in ACM/Ariba for study related cost
• Updates the trial and site information as necessary in Corporate Clinical Trial Registry (CCTR) in a timely manner
• Attends appropriate training programs and project teleconferences as applicable.
• Maintains the study status tracking and provides analysis report to Study Manager.
• Assists Study Manager on study budget control by timely tracking and reporting of actual cost and forecast drafting.
• Coordinates Clinical Study Agreement approval to ensure site initiation on time.
• 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.

2. 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 Client 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 client’s global value system across all interactions.

Qualification:

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

2. Organizational skills o Work independently and also as a team member. Receives instruction primarily on unusual situations. o Ability to organize tasks, time and priorities, ability to multi-task

3. Scientific/technical/administrative excellence o Understand basic medical terminology, GCP requirements and proficient in computer operations.

4. SOP Compliance o Maintain knowledge and expertise on all relevant SOPs.

5. Communication and presentation skills o Ability to communicate effectively and appropriately with internal and external stakeholders.

6. Operational skills o Expertise in the current role and ability to handle more challenging tasks / role in a clinical trial.

7. Administrative excellence o 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 with colleagues 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 geographic boundaries

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.