Research Assistant - Douglasville, GA
Summary
The Research Assistant is responsible for comprehensive management, coordination, and oversight of clinical research studies, ensuring seamless execution and strict adherence to regulatory standards. This role requires a high level of organization, attention to detail, and the ability to collaborate effectively with various stakeholders, including investigators, sponsors, regulatory bodies, and study participants.
Essential Duties and Responsibilities
The individual in this role must be able to perform each essential function proficiently, with or without reasonable accommodation.
Regulatory Compliance
- Ensure all clinical studies comply with FDA and OHRP regulations.
- Review regulatory requirements and implement appropriate methodologies, practices, and procedures to maintain compliance across all research activities.
- Develop accurate source materials and ensure adherence to protocols by site staff.
- Oversee timely and precise data collection, documentation, entry, and reporting within sponsor and OMRC databases.
- Verify proper credentialing and training of research team members in accordance with study protocols.
- Maintain all regulatory documentation to meet sponsor, site, and applicable regulatory requirements.
- Screen potential research participants for eligibility and obtain informed consent per study protocols.
Communication and Collaboration
- Act as a liaison between internal and external stakeholders, including sponsors, monitors, investigators, and study participants.
- Work closely with the Principal Investigator (PI) and research team to develop and enhance systems and infrastructure that ensure research quality and compliance.
Quality Control and Audits
- Conduct ongoing quality control audits to ensure adherence to research protocols.
- Maintain accountability for investigational drugs, including distribution and proper storage.
- Educate patients on investigational drug administration, including monitoring and recording daily temperatures.
- Monitor and document temperature readings for all study-related products.
Administrative Responsibilities
- Manage the clinical study email inbox and respond to communications promptly.
- Prepare and maintain patient charts in accordance with study protocols.
- Order and manage inventory for research supplies.
- Schedule study participant appointments and coordinate logistics.
- Assist providers with ECG procedures as needed.
- Process and prepare biological samples for shipment per study requirements.
- Ensure proper disposal of laboratory and study-related materials following OSHA guidelines.
- Verify operational functionality of all study-related equipment.
- Process orders for newly initiated studies.
- Maintain accurate study documentation and filing systems.
- Train in study-specific software and systems.
- Attend study initiation visits and investigation meetings as required.
- Set up and manage electronic devices for studying subjects.
- Maintain regular, reliable attendance and fulfill additional responsibilities as assigned.
- Ensure all study team members maintain necessary certifications.
Additional Information
Public-Facing Role: This position interacts with external stakeholders, including patients, vendors, regulatory bodies, and community leaders.
Qualifications and Requirements
Education
- High school diploma or equivalent required.
Experience
- 1-3 years of experience in clinical research operations, preferably in a coordinator role.
- Certified Clinical Research Coordinator (CCRC) or a minimum of 3,000 hours of relevant research experience.
- Strong attention to detail, self-motivation, and the ability to perform all duties in compliance with regulatory guidelines.
Technical Skills
- Proficiency in Microsoft Office Suite and research-specific software applications.
Knowledge & Compliance
- Strong understanding of medical terminology and HIPAA privacy laws.
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.
Apply for this job
*
indicates a required field