Job Description

We are seeking a detail-oriented and analytical Clinical Research Analyst to support clinical studies and trials through data analysis, documentation, and reporting. The ideal candidate will be responsible for collecting, organizing, and interpreting clinical data to support research objectives and regulatory compliance.

Key Responsibilities:

• Collect, clean, and analyze clinical trial data from various sources

• Ensure accuracy and integrity of data entered into clinical databases

• Assist in designing study protocols, case report forms (CRFs), and data collection tools

• Prepare statistical summaries, charts, and reports for internal teams and regulatory submissions

• Collaborate with clinical research coordinators, investigators, and regulatory teams

• Monitor ongoing studies to ensure protocol compliance and data quality

• Support the development of research publications, abstracts, and presentations

• Conduct literature reviews and stay updated on clinical and scientific advancements

• Maintain documentation in accordance with Good Clinical Practice (GCP) and ICH guidelines

• Assist in audit preparation and regulatory inspections as needed

Required Qualifications:

• Bachelors degree in Life Sciences, Public Health, Biostatistics, or a related field

• 2+ years of experience in clinical research, clinical data analysis, or related role

• Familiarity with GCP, ICH guidelines, and clinical trial processes

• Proficiency in Microsoft Excel and statistical software (e.g., SAS, SPSS, R)

• Strong analytical, problem-solving, and organizational skills

• Excellent written and verbal communication skills

• High attention to detail and ability to work independently or in a team

Preferred Qualifications:

• Masters degree in Clinical Research, Biostatistics, or Epidemiology

• Experience with EDC systems (e.g., Medidata, REDCap, Oracle Clinical)

• Certification in clinical research (e.g., CCRP, ACRP)

• Knowledge of regulatory requirements (FDA, EMA, etc.)

Job Tags

Similar Jobs