Kelly Science and Clinical has been at the forefront of matching top-tier talent with groundbreaking career opportunities. With decades of experience and thousands of satisfied partners, Kelly is known for facilitating successful employment relationships that benefit both employees and employers. Their current role for an Associate Essential Document Specialist is an exciting chance for professionals eager to make their mark in the clinical research field.
Responsibilities in the Job
As an Associate Essential Document Specialist, you will play a vital role in supporting the management of essential clinical trial documentation. Your main duties will include:
- Assisting Essential Document Specialists and Leads in maintaining accurate and up-to-date clinical trial records.
- Developing and optimizing strategies, tools, and procedures to streamline documentation processes.
- Ensuring that essential documents are processed in a timely manner while adhering to regulatory standards.
- Overseeing the integrity and readiness of essential clinical trial documents.
- Generating and maintaining Trial Master File (TMF) Plans.
- Assisting with the archival process and reviewing TMF content.
- Liaising with clinical teams and external partners to ensure seamless communication and document management.
- Providing detailed reports on the status of the TMF and supporting audit and inspection readiness.
Qualifications
To excel as an Associate Essential Document Specialist, candidates must meet the following criteria:
- Educational Background: A minimum of a high school diploma is required. However, a Bachelor’s degree in a relevant field is preferred.
- Experience: At least 1 year of experience in clinical research or a related role is essential.
- Regulatory Knowledge: General knowledge of ICH-GCP guidelines and relevant regulations is expected.
- Understanding of Clinical Processes: Familiarity with clinical development and trial management systems is crucial for effective document handling.
Skills
The ideal candidate for this position should possess a blend of technical and interpersonal skills, including:
- Attention to Detail: Precision in maintaining documentation integrity.
- Time Management: Ability to manage multiple tasks and meet varying deadlines.
- Technical Proficiency: Skills in Adobe Acrobat and the Microsoft Office Suite (Word, Excel, Outlook).
- Knowledge of eTMF: Familiarity with electronic Trial Master Files is an advantage.
- Communication Skills: Strong written and verbal communication for effective collaboration with internal and external teams.
