Exciting opportunity with an innovative biopharmaceutical company dedicated to advancing therapies in the field of genetic disorders. Their mission is to deliver transformative treatments that make a meaningful impact on patients' lives. They are committed to fostering a collaborative and dynamic work environment that values creativity, integrity, and continuous improvement.

Position Overview: Seeking a highly experienced and motivated Senior In-house Clinical Research Associate (CRA) to join their team. In this role, you will be responsible for overseeing and managing clinical trials, ensuring compliance with regulatory requirements, and contributing to the development of life-changing therapies. You will work closely with cross-functional teams to ensure the successful execution of clinical studies.

Key Responsibilities:

• Oversee the conduct of clinical trials from initiation to close-out.
• Ensure compliance with ICH-GCP guidelines, regulatory requirements, and company SOPs.
• Monitor trial progress, including site performance and data quality.
• Conduct site management activities such as site selection, initiation, monitoring, and close-out visits.
• Collaborate with investigators, study coordinators, and other stakeholders to ensure smooth study operations.
• Review and manage study documentation, including informed consent forms, case report forms, and regulatory submissions.
• Provide training and support to study sites and internal team members.
• Participate in the development and review of study protocols, reports, and other study-related documents.
• Assist in the preparation for and conduct of regulatory inspections and audits.
• Stay current with industry trends and advancements in clinical research.

Qualifications:

• Bachelor’s degree in life sciences, nursing, or a related field; advanced degree preferred.
• Minimum of 5 years of experience as a CRA, with at least 2 years in a senior or lead role.
• Strong knowledge of ICH-GCP guidelines and regulatory requirements.
• Proven track record of successfully managing and monitoring clinical trials.
• Excellent communication, organizational, and problem-solving skills.
• Ability to work independently and as part of a team.
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Willingness to travel as needed.