Key Responsibilities
Clinical Protocol Review
- Assist in the review and understanding of clinical study protocols, informed consent forms, and related study documents.
- Support identification of protocol deviations, inconsistencies, and missing information.
- Coordinate with senior team members for protocol clarifications and updates.
- Maintain accurate documentation as per SOPs and regulatory guidelines.
Literature Search & Medical Writing Support
- Conduct systematic literature searches using scientific databases (PubMed, Google Scholar, etc.).
- Summarize published clinical data, safety information, and therapeutic background.
- Assist in preparing literature review reports, study summaries, and reference documents.
- Ensure proper citation and version control of documents.
Clinical Study Monitoring Support
- Support clinical trial monitoring activities under guidance, including site documentation review.
- Assist in verification of study data, case report forms (CRFs), and essential trial documents.
- Help track study progress, timelines, and compliance with GCP and regulatory requirements.
- Coordinate with clinical sites, investigators, and internal stakeholders for study-related activities.
Required Skills & Competencies
- Basic understanding of clinical research and clinical trial processes.
- Knowledge of GCP, ICH guidelines, and regulatory concepts (basic level).
- Strong attention to detail and documentation skills.
- Good written and verbal communication skills.
- Ability to perform literature searches and summarize scientific information.
- Proficiency in MS Word, Excel, and PowerPoint.
- Willingness to learn and work in a regulated environment.
