Clinical Research Coordinator II - School of Medicine, Department of Gynecology and Obstetrics

Emory•Atlanta, GA

13d

About The Position

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. This Clinical Research Coordinator II position is essential for the successful execution of two federally funded research studies — The HEALthy Brain and Child Development Study (HBCD) and Delineating the Role of ALDH2 in Endometriosis. The coordinator will provide critical support in participant recruitment, biospecimen collection, data management, and regulatory compliance across both studies. 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.

Requirements

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.

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.
For the HBCD Study: Screen and recruit eligible pregnant participants from Emory clinical sites.
Coordinate data and biospecimen collection (maternal blood, cord blood, umbilical cord, placenta) at delivery.
Maintain strong working relationships with providers, hospital staff, and Labor and Delivery units at Emory University Hospital Midtown, Emory John’s Creek Hospital, and Emory Decatur Hospital, as well as develop partnerships with non-Emory delivery hospitals.
Monitor admissions to identify delivery of study participants, communicate with L&D staff, and ensure timely transport, processing, packing, and shipment of biospecimens.
Attend study meetings, provide updates to the principal investigator (PI), and maintain consistent communication with participants to ensure study milestones are met.
For the ALDH2 and Endometriosis Study: Coordinate participant enrollment and consent for women (AFAB) undergoing clinically indicated laparoscopic surgery.
Collaborate with surgical and clinical teams at Emory and the Nezhat Medical Center to facilitate intraoperative biospecimen collection, including peritoneal fluid and endometrial tissue (eutopic and ectopic).
Manage the collection, labeling, processing, and documentation of biospecimens for ALDH2 activity, gene/protein expression, and 4-HNE analysis.
Oversee administration and tracking of validated pain assessment surveys (Numerical Rating Scale).
Ensure compliance with study protocols, data integrity, and secure sample handling and transfer to analytical sites.