Clinical Research Data Coordinator II- Winship Cancer Institute at Emory University

Brookhaven, Georgia, United States -

Full Time

Start Date

Immediate

Expiry Date

29 Apr, 26

Salary

0.0

Posted On

29 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Data Management, Database Design, Protocol Analysis, Data Entry, Serious Adverse Event Reporting, Medical Record Review, Clinical Trial Monitoring, Quality Control Audits, Regulatory Compliance, Data Acquisition, Source Document Creation, Case Report Forms Completion, Data Tracking, Training, HIPAA Compliance, Interventional Therapeutic Trials

Industry

Higher Education

Description

Discover Your Career at Emory University Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community. Description The Data Coordinator II, supports the research program within the Clinical Trials Office (CTO) of Winship Cancer Institute (WCI) at Emory University. Responsible for facilitating initial visit with study subject. Designs, builds, and maintains the functional operations of the database, ensuring accuracy and appropriate usage by all internal customers. Increases the functionality of the database to meet the needs of internal customers and members of the department. Manages complex projects related to data acquisition and tracking that are not related to a database. Analyzes subject data in relation to study protocol for entrance into study. 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. KEY 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. Also 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. Reports and addresses findings as appropriate. 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 WinshipÂ¿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. MINIMUM QUALIFICATIONS: 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. PREFERRED QUALIFICATIONS: Certification/license: ACRP/SoCRA (or equivalent) certification preferred within three (3) years of hire. Additional Details 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). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Telephone: 404-727-9867 (V) | 404-712-2049 (TDD). Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation, please contact the Department of Accessibility Services at accessibility@emory.edu or call 404-727-9877 (Voice) | 404-712-2049 (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination.

Responsibilities

The Data Coordinator II supports the research program by facilitating initial study subject visits, designing and maintaining functional databases for accuracy, and managing complex data acquisition projects. Key duties include serving as the primary Data Coordinator for complex interventional therapeutic clinical trials and independently managing all aspects of clinical data management.