Clinical Research Analyst

Job Description

The Clinical Research Analyst plays a crucial role in supporting the planning, execution, and analysis of clinical research studies. They are responsible for collecting, organizing, and interpreting data related to clinical trials and research projects. The ideal candidate possesses strong analytical skills, a solid understanding of clinical research methodologies, and exceptional attention to detail. The Clinical Research Analyst collaborates closely with cross-functional teams, including researchers, physicians, statisticians, and regulatory affairs personnel, to ensure the successful completion of clinical studies and the generation of high-quality data.Responsibilities:1. Support the design and development of clinical research studies, including protocol development, study documentation, and data collection tools.2. Assist in the preparation and submission of study protocols, informed consent forms, and other required documentation to regulatory authorities and ethics committees.3. Coordinate and monitor the implementation of clinical research studies, ensuring adherence to protocols, regulations, and good clinical practices (GCP).4. Collect and compile data from various sources, including electronic health records, case report forms, laboratory results, and patient interviews, ensuring accuracy, completeness, and timeliness.5. Perform data cleaning, coding, and quality control checks to ensure data integrity and accuracy.6. Conduct statistical analysis using appropriate software and techniques, interpret and summarize findings, and generate reports, graphs, and charts.7. Collaborate with biostatisticians and data managers to develop statistical analysis plans and ensure appropriate data management practices.8. Maintain study databases, ensuring data confidentiality, security, and compliance with relevant regulations.9. Assist in the preparation and review of study reports, manuscripts, and presentations for conferences and scientific publications.10. Stay up to date with industry standards, regulatory guidelines, and emerging trends in clinical research methodologies.11. Contribute to process improvement initiatives, develop standard operating procedures (SOPs), and implement best practices for efficient and compliant clinical research operations.12. Participate in cross-functional team meetings, providing input and insights on study progress, data analysis, and interpretation.13. Collaborate with investigators and study coordinators to resolve queries and address data-related issues.14. Support the training and mentorship of junior staff members, as applicable.Qualifications and Skills:1. Bachelors degree in life sciences, health sciences, biostatistics, or a related field. Advanced degree (e.g., Masters, Ph.D.) is preferred, B Pharma2. Proven experience (X years) working in a clinical research role, preferably as a clinical research analyst or in a similar capacity.3. Solid understanding of clinical research methodologies, study design, and regulatory requirements (e.g., GCP, ICH guidelines).4. Proficiency in statistical analysis software (e.g.,, R, SPSS) and data management tools.5. Strong analytical skills, with the ability to analyze complex data sets, identify trends, and draw meaningful conclusions.6. Excellent attention to detail and ability to handle and organize large volumes of data accurately.7. Knowledge of database management systems and experience with electronic data capture (EDC) systems.8. Familiarity with data visualization tools (e.g., Tableau, Excel) to present and communicate findings effectively.9. Excellent written and verbal communication skills, with the ability to convey complex concepts clearly and concisely.10. Proficient in using Microsoft Office suite (Word, Excel, PowerPoint).11. Strong organizational and time management skills, with the ability to prioritize tasks and meet deadlines.12. Ability to work independently and collaboratively in a team environment, fostering effective relationships with colleagues and stakeholders.13. Knowledge of clinical trial regulations and experience with regulatory submissions is a plus.14. Certification in clinical research (e.g., ACRP, SoCRA)

Keyskills :
research analysisclinicalresearch