Clincademy

Regulatory Compliance: Understanding of UK regulatory requirements governing clinical trials, including ICH-GCP guidelines, MHRA regulations, and EU directives.

Documentation Management: Proficiency in maintaining and organizing trial documentation, including study protocols, informed consent forms, regulatory submissions, and investigator site files.

Ethics and Governance: Knowledge of ethical considerations in clinical research and experience in obtaining ethics committee approvals and managing trial governance processes.

Clinical Trial Operations: Familiarity with the operational aspects of clinical trials, including site selection, study start-up activities, monitoring visits, and close-out procedures.

Data Management: Basic understanding of clinical data management principles and experience in data entry, query resolution, and maintaining data integrity.

Communication Skills: Effective verbal and written communication skills to liaise with internal teams, investigators, study sites, and regulatory authorities.

Organizational Skills: Strong organizational skills to manage multiple tasks simultaneously, prioritize workload effectively, and meet deadlines in a fast-paced environment.

Attention to Detail: Keen attention to detail to ensure accuracy and completeness in all trial-related documentation and data entry activities.

Problem-Solving Abilities: Ability to identify issues or discrepancies and implement appropriate solutions or escalation procedures in a timely manner.

Teamwork and Collaboration: Ability to work collaboratively as part of a multidisciplinary team, supporting colleagues and contributing to the overall success of clinical trial projects.

Adaptability: Flexibility to adapt to changing priorities, procedures, and regulations in the clinical trial environment.

Computer Literacy: Proficiency in using computer software and electronic systems commonly used in clinical research, such as EDC systems, CTMS, and document management platforms.

Quality and Compliance: Commitment to maintaining high standards of quality and compliance throughout all aspects of clinical trial conduct.

Continuous Learning: Willingness to stay informed about developments in the field of clinical research and participate in relevant training and professional development activities.

Patient-Centric Approach: Understanding the importance of patient safety and well-being in clinical trials and demonstrating a patient-centric approach in all activities.