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Emory University Clinical Research Coordinator III in Atlanta, Georgia

Description

  • 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

PREFERRED QUALIFICATIONS:

  • 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

MINIMUM QUALIFICATIONS:

(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.

Additional Details

  1. 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

  1. Facilitates financial tasks for research and clinical trials

  2. 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

  1. 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

  1. 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

  1. 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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