Clinical Research Coordinator II

Morehouse School of Medicine; Atlanta (GA); On-site; USD 70,000 - 110,000; Full time

Job summary

Morehouse School of Medicine is seeking a seasoned clinical research professional to manage substantial aspects of large trials or multiple smaller projects. The role involves staff training, data management oversight, participant interfaces, and ensuring protocol compliance across study activities.

Responsibilities include IRB monitoring, sponsor communications, and contributing to policy improvements. Depending on credentials, duties may include phlebotomy or diagnostics, with potential

Qualifications

• Knowledge of clinical research regulatory requirements (GCP/ICH).
• Proficiency in Microsoft Word, Excel and PowerPoint.
• Strong written and verbal communication skills.
• Excellent organizational and problem-solving abilities.
• Effective time management and prioritization of multiple tasks.

Responsibilities

• Independently manages significant aspects of a large clinical trial or all aspects of small trials.
• Trains and provides guidance to staff.
• Oversees data management for research projects.
• Interfaces with participants and resolves protocol issues.
• Authorizes purchases for supplies and equipment maintenance.
• Monitors IRB submissions and responds to requests and questions.
• Leads in proposing improvements to policies/processes.
• Assists in grant proposals and study protocols.
• May perform phlebotomy, specimen collection or diagnostics as trained.
• Performs supervisory duties as assigned.

Skills

GCP/ICH knowledge

MS Office

Written communication

Organizational skills

Time management

Education

High School Diploma or GED

Two years of college in scientific/health/business

Licensed Practical Nurse (LPN)

Bachelor's degree in scientific/health/business

Master’s degree, MD or PhD in scientific/health/business

Certified Research Administrator (CRA) or Clinical Research Coordinator (CRC)

Job description

Position Summary

DUTIES PERFORMED BUT NOT LIMITED TO: 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 Knowledge, Skills, and Abilities Knowledge of applicable clinical research regulatory requirements (i.e., Good Clinical Practice ( GCP ) and International Conference on Harmonization ( ICH ) guidelines) Computer skills, including proficiency in Microsoft Word, Excel, and PowerPoint Written and verbal communication skills Excellent organizational and problem-solving skills Effective time management skills and ability to manage competing priorities

Minimum Qualifications

Education and Experience 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 of 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, or Certified Research Administrator ( CRA ) or Clinical Research Coordinator ( CRC preferred)

Preferred Qualifications