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Northeast Georgia Health System is rooted in a foundation of improving the health of our communities.

About the Role:

Job Summary

Under the direction of the research manager, the research data coordinator is responsible for completing clinical research forms and responding to sponsor queries according to departmental and sponsor guidelines for timely and accurate submission. Responsible for maintaining data and documentation in the research patient's medical record. Responsible for all aspects of data entry and management, including integrity of the data. Works in compliance with regulatory requirements, and the standards and system policies and procedures of the department and institution. Will communicate data and system related information to the research staff and sponsors. Will work closely with study monitors to ensure compliance with study requirements. Be be an active participant during sponsor audits.

Minimum Job Qualifications

• Licensure or other certifications:

• Educational Requirements: High School Diploma or GED.

• Minimum Experience: Two (2) years related experience.

• Other:

Preferred Job Qualifications

• Preferred Licensure or other certifications:

• Preferred Educational Requirements: Associates Degree and experience with data entry and computers.

• Preferred Experience:

• Other:

Job Specific and Unique Knowledge, Skills and Abilities

• Knowledge of medical terminology and study protocols

• Excellent communication, writing and interpersonal skills; ability to work effectively in a team

• Competency with Windows, CTMS, and EMR/EHR environment / data applications & data entry

• Displays strong problem solving and organizational skills

• Willingness to participate in formal and non-formal educational opportunities to remain current and expand knowledge base. Complete professional training programs such as GCP, CTEP, and NIH training as required.
  

Essential Tasks and Responsibilities

• Maintains management of data throughout a clinical trial. Enters study participant information (data) into all required software applications (i.e. EMR, Clinical Trials Management System, sponsor specific database, etc.) Documents and files data according to ALCOA-C principles and reports source verified data. Identifies basic medical terms associated with clinical studies. Contributes to process improvements by assisting with development of tools to capture data in compliance with ALCOA-C. Reviews and resolves queries within 3-5 days of notification, reports as ongoing metric, and maintain notes and data management log.

• Utilizes best practices and resources to standardize data collection, management, and submission. Collects source documents and uses study-specific tools and provided checklists and enters data within 3-5 days upon receipt provided by CRC or obtained directly. Communicates with sponsor by phone and/or email to address any protocol issues related to quality management of data entry (i.e. adverse events, SAEs). Communicates with research coordinators to ensure that patient charts as well as adverse event logs and adverse event documents are organized and accurate.

• Supports data quality assurance. Performs internal chart audits supporting monitor visits and scheduled external audits. Maintains passwords for all required systems (internal and external) and retains records in safe and secure environment. Escalates non-compliant data collection and/or submission during weekly metric reporting. Participates in departmental required meetings and trainings such as sponsor site visits, protocol updates, Research Committee meetings, etc.
  

Physical Demands

• Weight Lifted: Up to 20 lbs, Occasionally 0-30% of time

• Weight Carried: Up to 20 lbs, Occasionally 0-30% of time

• Vision: Heavy, Constantly 66-100% of time

• Kneeling/Stooping/Bending: Occasionally 0-30%

• Standing/Walking: Occasionally 0-30%

• Pushing/Pulling: Occasionally 0-30%

• Intensity of Work: Occasionally 0-30%

• Job Requires: Reading, Writing, Reasoning, Talking, Keyboarding, Driving

Working at NGHS means being part of something special: a team invested in you as a person, an employee, and in helping you reach your goals.

NGHS: Opportunities start here.

Northeast Georgia Health System is an Equal Opportunity Employer and will not tolerate discrimination in employment on the basis of race, color, age, sex, sexual orientation, gender identity or expression, religion, disability, ethnicity, national origin, marital status, protected veteran status, genetic information, or any other legally protected classification or status.