Clinical Research Data Coordinator II- Winship Cancer Institute

Emory • Atlanta, GA

11d • Onsite

About The Position

The Data Coordinator II supports the research program within the Clinical Trials Office (CTO) of Winship Cancer Institute (WCI) at Emory University. This role is responsible for facilitating initial visits with study subjects, designing, building, and maintaining the functional operations of the database to ensure accuracy and appropriate usage. The position also involves increasing database functionality to meet customer needs, managing complex data acquisition and tracking projects, analyzing subject data for study entrance, ensuring data is entered into EDC per sponsor expectations, and facilitating study monitoring visits and query resolution.

Requirements

• Bachelor Degree and at least two (2) years of clinical research data management experience OR High School Diploma or GED and at least six (6) years of clinical research data management experience OR an equivalent combination of education and experience.

Nice To Haves

• Certification/license: ACRP/SoCRA (or equivalent) certification preferred within three (3) years of hire.

Responsibilities

• Primary Data Coordinator (DC) for complex interventional therapeutic clinical trials, including multi-center trials and WCI held Investigator Initiated Trials (IITs) in complex areas such as hematologic cancers, Bone Marrow Transplant (BMT), Phase I trials, etc.
• Independently responsible for all aspects of clinical data management including creation and collection of source documents, completion of case report forms, and tracking and reporting of serious adverse events.
• Reviews and analyzes information from medical records (clinic notes, pathology reports, radiology reports, patient questionnaires, etc.) to extract data for all assigned research protocols including but not limited to industry, cooperative group, and investigator-initiated studies.
• Accurately captures and enters data into clinical trial databases as necessary, and within timelines set by study sponsors or CTO.
• Collects and maintains complete records and metrics on each research study participant.
• Consolidates clinical data and reports for investigators as needed.
• Assists in the review and evaluation of potential research studies and communicates effectively with CTO management and leadership regarding feasibility of proposed projects.
• 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.
• Provides support, ongoing education and updates to study team members, physicians, nurses, and other healthcare professionals regarding data-related protocol activities.
• Supports Data Team Supervisor in onboarding, training, and quality assurance of DC I position, as directed by DT Supervisor or Clinical Research Operations Manager (CROM).
• Serves as a resource to provide support and guidance to less experienced DCs and other study team members.
• Attends protocol related training meetings and completes all required study training.
• Liaises with sponsors and the in-house monitoring team, schedules monitoring visits, and addresses monitoring report findings.
• Leads the DC effort in preparing for and participating in quality control audits to verify the accuracy, completeness, and confidentiality of research data.
• Serves as the lead DC in preparing for internal and external audits (e.g., sponsor, regulatory agencies), addressing identified data deficiencies, and developing corrective action plans post audit.
• Establishes and maintains procedures and systems (i.e., computerized database) for research coordination and data management.
• Provides support to Winship's Informatics team as they develop and improve research information systems.
• 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.
• Maintains confidentiality standards for all potential and enrolled patients; complies with federal Health Insurance Portability and Accountability Act (HIPAA) regulations.
• Performs other duties as assigned.

Benefits

• Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law.
• Emory University does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.
• Students, faculty, and staff are assured of participation in university programs and in the use of facilities without such discrimination.
• Emory University complies with Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity, and affirmative action (for protected veterans and individuals with disabilities).
• Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level