Remote Clinical Research Protocol Writer Jobs in Georgia

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.

The Clinical Research Data Coordinator I supports the research program within the Clinical Trials Office (CTO) of Winship Cancer Institute (WCI) at Emory University. The Data Coordinator I, primarily serves in a supportive role coordinating and maintaining data activities related to clinical trials. This role collaborates with the clinical, informatics, quality monitors, and/or regulatory teams to document and report study patient enrollment, treatment, and follow-up information into databases as specified by research protocols.

KEY RESPONSIBILITIES:

• Supports and assists in all aspects of clinical data management, protocol data management, including creation and collection of source documents, completion of case report forms, and tracking and reporting of serious adverse events.
• Primary Data Coordinator (DC) for therapeutic and non-therapeutic clinical trials across all disease teams, including complex areas such as hematologic cancers, Bone Marrow Transplant (BMT), Phase I trials, etc. More experienced Data Coordinators will be assigned to multi-center trials and Winship-held Investigator-Initiated Trials (IITs).
• Reviews 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.
• 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 data query management.
• Attends protocol related training meetings and completes all required study training.
• Prepares for and assists with internal quality control audits to verify the accuracy, completeness, and confidentiality of research data. Reports and addresses findings as appropriate.
• Provides support during internal and external monitoring and auditing (e.g., sponsor, regulatory agencies) preparation, including supporting data deficiency corrections and development of corrective action plans post audit.
• Assists in the establishment and maintenance of procedures and systems (i.e., computerized database) for research coordination and data management.
• Assures ongoing compliance with all departmental, institutional, and federal requirements and regulations. Maintains controls to assure accuracy, completeness, and confidentiality of research data.
• Maintains confidentiality standards for all potential and enrolled study participants; complies with federal Health Insurance Portability and Accountability Act (HIPAA) regulations.
• Performs other duties as requested.

MINIMUM QUALIFICATIONS:

• High School Diploma or GED and three years of administrative support experience
• Or two years of college in a scientific, health related, or business administration program and one year of admin support or customer service experience
• Or licensed as a practical nurse (LPN) and one year admin support or one year of licensed practical nursing experience
• Or bachelor's degree, Master's degree, MD or PhD in a scientific, health related or business administration program.

This position is intended to support clinical research and all clinical training requirements must be tracked and monitored through Emory Healthcare under the credentialing category of Clinical Researcher.

NOTE: This role will be granted the opportunity to work from home regularly but must be able to commute to Emory University on a flexible weekly schedule based upon business needs.  Schedule is based on agreed upon guidelines of department. This role requires residency in the state of GA. Emory reserves the right to change remote work status with notice to employee.

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.