Emory University Clinical Research Coordinator III in Atlanta, Georgia
Recruitment of study participants and discussion of informed consent
Obtain informed consent as necessary
Provides direction in auditing and monitoring activities.
Collaborates with multidisciplinary researchers to establish research programs that integrate new advances in clinical trials management.
Develops and conducts patient and family education.
Provides leadership and expertise in identifying and writing research grants, publications in medical and nursing literature, study materials, brochures and correspondence.
Conducts ongoing training of clinical trials staff, providing updated information on internal processes and resources and external benchmarks.
For multi-site studies, ensures sites fully understand and comply with study protocol and provides training of site coordinators and/or supervision of site coordinators.
Actively participates in planning and evaluation processes to improve and advance clinical research within the organization.
Along with Principal Investigator, may represent a study at Patient Safety Monitoring Board meetings at the NIH.
Processing of biological samples – training/credentialing will be provided as needed
Experience with FDA protocols preferred
Excellent communication skills
Experience running clinical trials
Actively enrolled and pre-consents in clinic patients for studies
Interacts with pharmacy to ensure study drug delivery
Evaluates patients throughout duration of study
Collects clinical outcome study data
Performs data entry
Collects and reports information on serious adverse events to IRB, FDA and PI
Interfaces with IRB
Ensures IRB documentation is up to date
May interface with FDA
Ensures that FDA regulatory documents are up to date
Works closely with PI and Study Team to run clinical trials
Willing to work on Multiple Sites (Hugh Spaulding, Egleston, Scottish Rite) in addition to Grady Healthcare (Sickle cell clinic and acute care centers/EDs/wards)
Willing to travel between sites during the workday as dictated by needs of clinical studies and research
Able to work with both Adult and Child study participants
Interested in contributing to Grady Adult Sickle Cell Research and other Center Activities in addition to Pediatric Emergency Medicine Research activities
Some flexibility with hours when study patient is enrolled (i.e. lab processing at 8am, occasional weekend AM study visit)
Able to interface with lab to ensure study samples administered properly, arrange shipping of samples
Ensure research charges are appropriately allocated
Travel to Investigator/Study Coordinator meetings when necessary
Prior experience and knowledge of clinical trials, research principles and methodologies, and study design.
Working knowledge of federal regulations and regulatory requirements for conducting research.
Good computer skills including working knowledge of a PC and Microsoft Office (Word, Access, Excel, and PowerPoint) and basic statistics.
Self-directed and motivated to work independently toward short and long term goals.
Good communication, organization and interpersonal skills
(1.) High School Diploma or GED and seven years of clinical research experience OR
(2.) Two years of college in a scientific, health related or business administration program and five years of clinical research experience OR
(3.) Licensed as a Practical Nurse (LPN) and four years of clinical research experience OR (4.) Bachelor's degree in a scientific, health related or business administration program and three years clinical research experience OR
(5.) Master's degree, MD or PhD in a scientific, health related or business administration program and one year of clinical research experience Certified Research Administrator (CRA) or Clinical Research Coordinator (CRC) preferred.
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.
- Manages all regulatory processes related to clinical research activities
Completes IRB preparation, submission, modifications, reporting and termination activities
Maintains all regulatory documents
Participates in sponsor correspondence, monitoring and study meetings
Facilitates financial tasks for research and clinical trials
Responsible for research protocol development, conduct and facilitation
Performs participant screening, enrollment, study activities and communication
Coordinates study visits and procedures including specimen acquisition, transport, documentation and shipment
Maintains equipment and supply resources for research studies
- Completes data management activities
Assist in the development and completion of source and CRF documentation.
Completes data entry and ensures data integrity
Supports statistical services needs
- Responsible for quality and education activities
Monitors compliance throughout all study activities
Engages compliance oversight as needed
Participates in education activities to support specific research activities and primary role
Maintains all licensure, certification and system education requirements for role
Participates in educational activities related to study needs for study staff, investigator team and patient care staff
- Provides direct patient care to conduct research protocols
Provides direct research coordinator evaluation0 according to standards of practice
Administers research medications under a study specific protocol
Completes coordinator physical assessment, vital signs and venous access
Provides health education to participants as part of a study protocol
Completes documentation and order entry within the medical record
Willing to obtain training and credentialing to Complete phlebotomy for the acquisition of research specimens
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Job Number 34436
Job Type Regular Full-Time
Division School Of Medicine
Department SOM: Peds: Emergency Medicine
This position may involve the following Health and Safety issues: Working with human blood, body fluids, tissues, or other potentially infectious materials.
Job Category Research & Research Administration
Emory University is an equal opportunity/equal access/affirmative action employer fully committed to achieving a diverse workforce and complies with all applicable Federal and Georgia State laws, regulations, and executive orders regarding nondiscrimination and affirmative action in its programs and activities. Emory University does not discriminate on the basis of race, color, religion, ethnic or national origin, gender, genetic information, age, disability, sexual orientation, gender identity, gender expression, and veteran's status. Inquiries about this statement should be directed to the Office of Equity and Inclusion, 201 Dowman Drive, Administration Bldg, Atlanta, GA 30322
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