Clinical Research Data Coord.

Job Requirements

Position Summary

Clinical Research Data Coordinator assumes responsibility for the overall data coordination of oncology research trials. This position will be responsible for obtaining research data and entering data in the Electronic Data Capture (EDC) for complex interventional therapeutic and supportive care trials including but not limited to industry and cooperative group studies. Ensures data from source is entered in EDC per Sponsor contract expectations if not sooner. Facilitates study monitoring visits and prompt resolution of all study related queries.

Responsible for coordinating with patients, participating physicians, clinical research coordinators, quality, regulatory and study sponsor to ensure data integrity. Support processing and shipping of biospecimens. Must be self-starter/motivated, detail-oriented, willing to develop the clinical research service line within the oncology program. Willing to learn and train on required clinical research database and clinical trial management system.

Minimum Requirements

Education

• Bachelor's degree and one year of clinical experience
• Associate degree with minimum of three years clinical experience

OR

• Current certification in clinical research (SOCRA-CCRP, ACRP-CCRC or ACRP-CP) with five years clinical experience

Experience

• See above

License/Registration/Certifications

• N/A

Preferred Requirements

Preferred Education

• Bachelor or Masters in a Heath Related field

Preferred Experience

• Knowledge of clinical data and Good Clinical Practices; knowledge of medical terminology
• One (1) year oncology experience
• Clinical research experience
• Phlebotomy experience

Preferred License/Registration/Certifications

• Certification in research (CCRC, CCRP)

Core Job Responsibilities

• Reviewing medical records: Reviews and analyzes information from medical records (clinic notes, pathology reports, radiology reports, patient questionnaires, etc.) to extract data for all assigned research protocols
• Entering Data: Entering data into data bases and forms, ensuring data is entered into the database in a timely and accurate manner
• Contacting sources: Contacting physicians, patients, and other sources to obtain follow-up information on missing data
• Maintaining logs: Maintaining screening and enrollment logs and tracking patient progress
• Record Maintenance: Collects and maintains complete records and metrics on each research study participant
• Monitoring Compliance: Monitoring protocol compliance and reporting instances of noncompliance
• Biospecimens: Processing, shipping, and tracking of biospecimens for research
• Attends study team meetings and provides updates to study team members regarding protocol data management activities, including data entry timelines, database locks, unique study requirements, and query management
• Attends protocol related training meetings and completes all required study training
• Supports efforts in preparing for and participating in quality control audits to verify the accuracy, completeness, and confidentiality of research data
• Supports preparation for internal and external audits (e.g., sponsor, regulatory agencies), addressing identified data deficiencies, and developing corrective action plans post audit
• Must be able to work as a team member with other Research staff, doctors, departments, community, and other components
• Assures ongoing compliance with all departmental, institutional, and federal requirements and regulations and department policies
• Maintains controls to assure accuracy, completeness, and confidentiality of research data
• Must have own transportation to other hospitals and doctors' offices
• Must be flexible in responsibilities and work schedule
• Must be meticulous with detail
• Must be able to read, write, and speak English fluently
• Must have good communication skills
• Must be able to respond calmly and efficiently in high stress situations
• Must be able to sit for long periods of time, filling out paperwork
• Must be self-directed and able to work without supervisor
• Performs other duties as assigned