Clinical Trial Assistant Cover Letter

I submit this application to express my sincere interest in the clinical trial assistant position.

In my previous role, I was responsible for subject matter expertise to teams to develop global strategies for the disclosure of clinical documents in accordance with applicable regulatory requirements.

My experience is an excellent fit for the list of requirements in this job:

• Experience/ proven track record in in-house support
• Good standard of computer literacy with MS Office, Outlook, Word & Excel
• Knowledge of industry standards and best practices in clinical data management, ISO 14155 and ICH GCP
• Proficiency both in local language and English
• Advanced knowledge and experience with a variety of Office applications that support the Administrative function
• Expert knowledge of MS Office software, SharePoint experience desirable
• Excellent interpersonal and communication skills, uses tact and diplomacy sensitivity for handling confidential information
• Excellent organizational skills, initiative, multi-tasking abilities and attention to detail

I submit this application to express my sincere interest in the clinical trial assistant position.

In my previous role, I was responsible for required data from studies and sites to comply with regulatory and government requirements (Sunshine Act, FWA, Human Subject Protection training, Clinical Insurance).

My experience is an excellent fit for the list of requirements in this job:

• Proficient computer skills across Microsoft Office Suite (including MS Word, Excel, PowerPoint and SharePoint)
• Moves actions forward without the need for continual supervision
• Knowledge of medical and pharmaceutical industry terminology
• Previous experience in a corporate environment would be beneficial
• Able to work well in a team but also independently
• Good working knowledge of Microsoft Office tools, CARS will be beneficial
• Ideally previous experience with site contracts
• Ideally previous experience with payments

Please consider me for the clinical trial assistant opportunity. I am including my resume that lists my qualifications and experience.

In my previous role, I was responsible for clinical Quality Assurance (CQA) oversight to ensure that global clinical studies conducted by Alcon are in compliance with applicable regulations, guidelines and quality standards established by the relevant regulatory agencies and Novartis.

Please consider my experience and qualifications for this position:

• Demonstrates and promotes teamwork
• Comfortable with making decisions up to their level of authority
• Ensure robust and complete clinical plans are developed
• Manage Contract Research Organization oversight, including staff
• Develop Clinical Evaluation Report (CER) per needs
• Self-motivated individual who is able to manage multiple tasks and priorities in an efficient manner
• Demonstrated track record of Compliance to regulations governing human clinical research
• Comfortable working closely with a team taking ownership/initiative where needed, and taking/delegating task appropriately

I would like to submit my application for the clinical trial assistant opening. Please accept this letter and the attached resume.

Previously, I was responsible for expert consultation during the planning through operations phases, regarding coding regulatory requirements and clinical policy guidelines.

Please consider my qualifications and experience:

• Tenacity and perseverance to ensure high level customer service
• Teamwork is a mandatory requirement as it involves building and maintaining internal/external networking and cross-functional collaboration
• High sense of urgency and commitment to excellence in the successful achievement of objectives and program execution
• Experience with EDC, IXRS and CTMS systems
• Working knowledge of FDA regulations and ICH/GCP guidelines
• Experience with review of essential documents and TMF management
• Computer proficiency and experience using a variety of software packages (e.g., Microsoft Word, Excel, Power Point, Project)
• Experience with clinical trials and the pharmaceutical industry preferred

I am excited to be applying for the position of clinical trial assistant. Please accept this letter and the attached resume as my interest in this position.

In the previous role, I was responsible for training in patient advocacy and clinical research engagement for team members (as applicable).

My experience is an excellent fit for the list of requirements in this job:

• Proven CTA experience in Czech Republic
• Experience with financial tasks such as contract and handling payments very beneficial
• Experience with eTMF very beneficial
• Knowledge of ICH/GCP including relevant Guidance documents from (FDA, ICH, and EMEA )
• Effectively manages time to meet task/project deliverables and deadlines in a manner that minimizes rework
• Takes appropriate care to ensure quality of data and work outputs
• Knowledge of MS Word and Excel and MS Office Suite in general
• Significant experience with Clinical Trial document management