Single Sponsor Senior CRA II - Oncology (UK based) Must have UK on-site and risk based monitori[...]

Must have UK on-site and risk based monitoring experience.

Job Responsibilities

• Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including verifying the accuracy and completeness of data collected and ensuring adherence to study protocols.
• Develop and implement tools, procedures, and processes to ensure quality monitoring, including creating standardized templates for monitoring reports and checklists for site visits.
• Contribute to the design, implementation, and delivery of processes, programs, and policies, including participating in the development of clinical trial protocols and providing input on study design and methodology.
• Manage and direct the work of lower-level professionals or manage processes and programs, including providing guidance and support to junior staff members and overseeing the day-to-day activities of clinical trial sites.
• Ensure accurate and timely documentation and reporting of clinical trial data, including maintaining detailed records of site visits and monitoring activities and preparing comprehensive reports for regulatory submissions.
• Collaborate with cross-functional teams to support clinical trial activities, including working closely with data management, biostatistics, and regulatory affairs teams to ensure the successful execution of clinical trials.
• Identify and resolve issues related to clinical trial conduct and data integrity, including troubleshooting problems with data collection and addressing discrepancies in study records.
• Provide training and mentorship to junior staff members, including conducting training sessions on monitoring techniques and best practices and offering ongoing support and guidance to help them develop their skills and expertise.

Qualifications

• Bachelor's degree in a related field.
• Minimum of 3-5 years of experience in clinical research or a related field.
• In-depth knowledge of clinical trial processes and regulations.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.

Certifications

• Certified Clinical Research Professional (CCRP) or equivalent certification preferred.

Necessary Skills

• Proficiency in clinical trial management systems and software.
• Strong organizational and time management skills.
• Attention to detail and accuracy.
• Ability to manage multiple projects and priorities simultaneously.
• Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements.

These tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.