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Research Assistant - Douglasville, GA

Douglasville, GA

Position Summary

The Research Assistant is responsible for the comprehensive management, coordination, and execution of clinical research studies, ensuring strict adherence to federal regulations and institutional protocols. This position plays a critical role in maintaining the integrity of research efforts and requires a high degree of organization, attention to detail, and effective communication with investigators, sponsors, regulatory agencies, and study participants.

Essential Duties and Responsibilities

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily, with or without reasonable accommodation.

Regulatory Compliance

  • Ensure all clinical research studies are conducted in full compliance with FDA, OHRP, and other applicable regulatory guidelines.

  • Interpret and apply regulatory requirements to research practices and protocols.

  • Develop and maintain accurate source documentation and ensure protocol adherence by study staff.

  • Collect, document, and report study data accurately in sponsor and internal databases.

  • Ensure all team members maintain appropriate credentialing and training per protocol requirements.

  • Maintain comprehensive regulatory documentation and ensure timely updates.

  • Conduct participant screening and obtain informed consent according to protocol.

Communication and Collaboration

  • Serve as the primary liaison for sponsors, monitors, investigators, and participants.

  • Collaborate with the Principal Investigator and research team to strengthen research infrastructure and quality assurance processes.

Quality Control and Audits

  • Perform ongoing quality assurance checks to ensure compliance with study protocols.

  • Maintain accountability for investigational products, including inventory management and temperature monitoring.

  • Educate participants on investigational product administration and monitor related documentation.

Administrative and Operational Support

  • Manage clinical study inbox and respond to inquiries in a timely manner.

  • Create and maintain accurate patient charts in compliance with study protocols.

  • Order and maintain inventory of research-related supplies and materials.

  • Coordinate and schedule participant appointments and study-related logistics.

  • Assist in ECG procedures and process biological samples according to protocol.

  • Dispose of laboratory and clinical waste in compliance with OSHA and safety regulations.

  • Ensure functionality of study-related equipment and assist in onboarding of new studies.

  • Participate in study initiation visits, training sessions, and investigator meetings.

  • Set up and manage electronic devices for use by study participants.

  • Maintain regular and dependable attendance, fulfilling other duties as assigned.

Qualifications and Requirements

Education

  • High school diploma or equivalent required.

Experience

  • 1–3 years of experience in clinical research operations, preferably in a research coordinator capacity.

  • Certified Clinical Research Coordinator (CCRC) credential or a minimum of 3,000 hours of relevant research experience.

Technical Skills

  • Proficiency in Microsoft Office Suite and other research-specific software applications.

Knowledge and Compliance

  • Strong working knowledge of medical terminology and HIPAA privacy regulations.

  • Demonstrated ability to manage complex regulatory requirements and ensure protocol adherence.

Physical and Mental Demands:

 

The physical and mental demands described below are representative of those required to perform this job successfully. Reasonable accommodations may be made for individuals with disabilities:

  • Physical Requirements:
    • Occasionally required to stand, walk, and sit for extended periods.
    • Use hands to handle objects, tools, or controls; reach with hands and arms.
    • Occasionally required to climb stairs, balance, stoop, kneel, bend, crouch, or crawl.
    • Occasionally lift, push, pull, or move up to 20 pounds.
  • Vision Requirements:
    • Close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

Note:
This job description is intended to provide a general overview of the role. Additional responsibilities may be assigned, or duties modified by the department supervisor based on operational needs.

 

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