Clinical Research Data Coord.

About the Role

A Clinical Research Data Coordinator is responsible for the overall data coordination of oncology research trials. This includes managing data for complex interventional therapeutic and supportive care trials, such as industry and cooperative group studies. The role involves ensuring data integrity, facilitating study monitoring visits, and resolving study-related queries promptly.

Responsibilities

• Review and analyze medical records (clinic notes, pathology reports, radiology reports, patient questionnaires, etc.) to extract data for assigned research protocols.
• Enter data into databases and forms accurately and in a timely manner.
• Contact physicians, patients, and other sources to obtain follow-up information on missing data.
• Maintain screening and enrollment logs and track patient progress.
• Collect and maintain complete records and metrics on each research study participant.
• Monitor protocol compliance and report instances of noncompliance.
• Process, ship, and track biospecimens for research.
• Attend study team meetings and provide updates on protocol data management activities, including data entry timelines, database locks, query management, and unique study requirements.
• Attend protocol-related training meetings and complete all required study training.
• Support efforts in preparing for and participating in quality control audits to verify data accuracy, completeness, and confidentiality.
• Support preparation for internal and external audits (e.g., sponsor, regulatory agencies), address identified data deficiencies, and develop corrective action plans post-audit.
• Work collaboratively with research staff, doctors, departments, and other stakeholders.
• Ensure ongoing compliance with all departmental, institutional, and federal requirements and regulations, as well as department policies.
• Maintain controls to assure accuracy, completeness, and confidentiality of research data.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree and one year of clinical experience, or
• Associate degree with a minimum of three years of clinical experience, or
• Current certification in clinical research (SOCRA-CCRP, ACRP-CCRC, or ACRP-CP) with five years of clinical experience.

Preferred Qualifications

• Bachelor’s or Master’s degree in a health-related field.
• Knowledge of clinical data and Good Clinical Practices (GCP).
• Knowledge of medical terminology.
• One year of oncology experience.
• Clinical research experience.
• Phlebotomy experience.
• Certification in research (CCRC, CCRP).

Skills

• Self-starter and highly motivated.
• Detail-oriented with a willingness to develop the clinical research service line within the oncology program.
• Ability to learn and train on clinical research databases and clinical trial management systems.
• Must have own transportation to travel to other hospitals and doctors' offices.
• Flexible in responsibilities and work schedule.
• Meticulous with detail.
• Fluent in reading, writing, and speaking English.
• Strong communication skills.
• Ability to respond calmly and efficiently in high-stress situations.
• Ability to sit for long periods while completing paperwork.
• Self-directed and able to work without constant supervision.