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Description
Seeking an experienced clinical research coordinator to join a clinical research team focused on diabetes and diabetic foot disease. Applicants with experience in diabetes and diabetic foot conditions will be given preference.
KEY RESPONSIBILITIES:
- Independently manages significant and key aspects of a large clinical trial or all aspects of one or more small trials, or research projects.
- Trains and provides guidance to less experienced staff.
- Oversees data management for research projects.
- Interfaces with research participants and resolves issues related to study protocols.
- Authorizes purchases for supplies and equipment maintenance.
- Determines effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
- Periodically audits operations including laboratory procedures to ensure compliance with applicable regulations; provides leadership in identifying and implementing corrective actions/processes.
- Monitors IRB submissions and responds to requests and questions.
- Interfaces with study sponsors, monitors and reports SAEs; resolves study queries.
- Provides leadership in determining, recommending, and implementing improvements to policies/processes.
- Assists in developing grant proposals and protocols.
- With appropriate credentialing and training may perform phlebotomy, specimens collection or diagnostics.
- May perform some supervisory duties.
- Performs related approved responsibilities as required.
JOB SPECIFIC DUTIES:
- Study Coordination: Oversee the day-to-day operations of clinical research projects related to diabetic foot ulcers. Collaborate with the research team to ensure all aspects of the studies are executed efficiently and in compliance with relevant protocols, regulations, and ethical guidelines.
- Participant Recruitment and Enrollment: Identify and screen potential study participants, providing them with detailed information about the research study. Obtain informed consent from eligible individuals and coordinate their enrollment into the trials.
- Data Collection and Management: Implement data collection procedures, including medical history, laboratory tests, wound assessments, and other relevant clinical data. Ensure accurate and timely data entry into electronic databases while maintaining data integrity and confidentiality.
- Regulatory Compliance: Assist in obtaining necessary approvals from investigational review boards and ensure documentation is up-to-date and complete throughout the course of the research projects.
- Clinical Monitoring: Monitor participants' progress throughout the trials, and promptly report any adverse events or deviations from the study protocols to the principal investigator and relevant authorities.
- Collaboration and Communication: Foster effective communication among the research team, healthcare providers, study sponsors, and other stakeholders involved in the diabetic foot ulcer projects. Coordinate study-related meetings and maintain documentation of discussions and decisions.
MINIMUM QUALIFICATIONS:
- High School Diploma or GED and seven years of clinical research experience.
- Or two years of college in a scientific, health related or business administration program and five years of clinical research experience.
- Or licensed as a Practical Nurse (LPN) and four years of clinical research experience.
- Or bachelor's degree in a scientific, health related or business administration program and three years clinical research experience.
- Or 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.
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.
Emory Supports a Diverse and Inclusive Culture
Emory University is dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, gender, genetic information, age, disability, sexual orientation, gender identity, gender expression, and veteran's status. Emory University does not discriminate in admissions, educational programs, or employment on the basis of any factor stated above or prohibited under applicable law. Students, faculty, and staff are assured of participation in University programs and in the use of facilities without such discrimination. Emory University complies with Executive Order 11246, as amended, 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. Emory University is committed to achieving a diverse workforce through application of its affirmative action, equal opportunity and nondiscrimination policy in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.
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