Clinical Research Coordinator II- School of Medicine, OBGYN

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 Clinical Research Coordinator II handles administrative activities generally associated with the conduct of clinical trials. This position requires flexibility to accommodate the unique demands of research involving pregnant participants and delivery-based biospecimen collection. Because deliveries can occur at any time, the coordinator may be required to work during evenings, weekends, or overnight hours to ensure timely collection and processing of samples within strict protocol timelines. A shifted schedule and participation in an on-call rotation may be implemented as needed to maintain continuous study coverage. Coordinators are expected to demonstrate initiative and accountability for study-related responsibilities, maintain a high level of productivity and attention to detail, and communicate proactively with study leadership regarding project progress and scheduling needs.

KEY RESPONSIBILITIES:

Manages research project databases, develops flow sheets and other study related documents, and completes source documents/case report forms. Provides guidance to less experienced staff. Interfaces with research participants, determines eligibility and consents study participants according to protocol. Approves orders for supplies and equipment maintenance. Assists in developing recruitment strategies and conducting screenings for study participants including interviews and questionnaires. Supervises collection of study specimens and processing. Establishes case packages for study procedures, monitors scheduling of procedures and charges, coordinates other services as needed. Ensures compliance with research protocols, reviews case report forms and audits for accuracy with source documents, attends monitoring meetings with sponsors. Prepares regulatory submissions. With appropriate credentialing and training may perform phlebotomy or diagnostics. Performs related approved responsibilities as required. Assists in the coordination and implementation of clinical research studies, including participant recruitment, enrollment, and follow-up in accordance with study protocols and regulatory requirements. Reviews medical records and conducts participant screenings to assess eligibility; obtains informed consent and administers study questionnaires or quality-of-life assessments asrequired. Collects, processes, and prepares biospecimens for shipment in compliance with study and institutional standards; may perform phlebotomy and related specimen handling procedures. Maintains accurate and complete study documentation, including source documents, case report forms, and data entry into approved databases. Coordinates study-related activities such as scheduling study visits, preparing case packages, ordering supplies, and maintaining study equipment. Participates in study meetings and contributes to ongoing communication with the principal investigator and study team to ensure timelines and objectives are met. Assists with quality assurance procedures and supports the preparation and tracking of regulatory submissions. Assists with screening participants, coordinating data and specimen collection at participating Emory hospitals, and supporting collaboration for timely biospecimen processing. Performs other related duties as assigned to support the success of the research program.

MINIMUM QUALIFICATIONS:

High School Diploma or GED and five years of clinical research experience. Or two years of college in a scientific, health related, or business administration program and three years clinical research experience. Or a licensed as a practical nurse (LPN) and two years clinical research experience. Or a Bachelor's degree in a scientific, health related, or business administration related program and one year of clinical research experience. Or a 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: Position tasks are generally required to be performed in-person at an Emory University location. Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee. 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: View phone number on click.appcast.io (V) | View phone number on click.appcast.io (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 View email address on click.appcast.io or call View phone number on click.appcast.io (Voice) | View phone number on click.appcast.io (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination. #J-18808-Ljbffr Emory University