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Description
The Clinical Research Coordinator II handles administrative activities generally associated with the conduct of clinical trials.
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.
ADDITIONAL JOB DETAILS:
The clinical coordinator will work in the Sleep Epidemiology Research Group in the Department of Epidemiology at the Rollins School of Public Health led by Dr. Dayna Johnson. The clinical coordinator will work under minimum supervision and manage several studies - a clinical trial in the hospital and an observational epidemiological study in the community. Our projects are aimed at sleep measurement and understanding determinants and health (cardiovascular, covid, cancer) consequences of sleep problems.
Working some evenings and weekends (3-4 hours twice a month) are a requirement for this position. The job responsibilities include operating as the project manager for several projects, submitting IRB documents, maintaining regulatory documents for clinical trials, coordinating the management of research equipment in the office, ensuring the research protocol is followed by all staff, and data are being logged appropriately in RedCap, coordinating meetings, processing and scoring sleep data from wearables using software on a provided computer, providing data summaries (in partnership with the study analyst), communicating with external teams, and representing the team at virtual meetings with internal and external researchers.
The candidate will also be responsible for managing and actively recruiting/scheduling research participants, completing research visits (data collection) in hospital or homes of participants (as part of a team), and processing participant incentives. They will work with outside laboratory to ship frozen samples from participants. In partnership with another team member, they will conduct the field visits which entail administering questionnaires, initializing air, light and noise monitoring devices, instructing participants on the sleep monitor and ambulatory blood pressure monitoring, and processing and mailing saliva samples. Several times a week, they will visit the homes of participants in the evenings and weekends to conduct the research visits, thus reliable transportation is required (mileage will be reimbursed). The candidate will review, produce quality control grades under the direction of Dr. Johnson. They will also oversee mailing the sleep and cardiovascular feedback letters to the participants, and to their physicians upon request from participants. They will also have the opportunity to contribute manuscripts and assist with grant writing. The candidate will engage in other research-related tasks as needed.
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 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.
PREFERRED QUALIFICATIONS:
- Masters in epidemiology or research related discipline.
- Experience with NIH funded clinical and population science, managing/supervising staff, completing regulatory documents for clinical trials, coordinating meetings, IRB submissions, and experience conducting research in a community setting with African American participants.
- The candidate should be very detailed, meticulous about data, and be knowledgeable regarding technology (e.g., wearables). Because of the engagement with recruitment, having an outgoing personality and comfort with talking with people is a benefit. It is critical to be highly organized and have strong oral and written communication skills.
- Reliable transportation is required as this position involves data enrollment (with another team member) in homes of participants (mileage will be reimbursed). The coordinator will need to be resourceful, thoughtful, and take initiative.
NOTE: Position tasks are required to be performed in-person at an Emory University location; working remote is not an option. Emory reserves the right to change this status with notice to employee.
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