Clinical Research Data Coord.

Spartanburg Regional Healthcare System•Spartanburg, SC

3d•Onsite

About The Position

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.

Requirements

Bachelor's degree and one year of clinical experience
Associate degree with minimum of three years clinical experience
Current certification in clinical research (SOCRA-CCRP, ACRP-CCRC or ACRP-CP) with five years clinical experience
Must be self-starter/motivated
Must be detail-oriented
Willing to learn and train on required clinical research database and clinical trial management system
Must be able to read, write, and speak English fluently

Nice To Haves

Bachelor or Masters in a Heath Related field
Knowledge of clinical data and Good Clinical Practices
Knowledge of medical terminology
One (1) year oncology experience
Clinical research experience
Phlebotomy experience
Certification in research (CCRC, CCRP)
Must have own transportation to other hospitals and doctors' offices
Must be flexible in responsibilities and work schedule
Must be meticulous with detail
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

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