Clinical Research Coordinator

System One is hiring a Clinical Research Coordinator to support the coordination and execution of clinical research protocols. The role involves participant screening and enrollment, study visit coordination, research data and documentation management, and monitoring study progress in accordance with regulatory and ethical standards.

Responsibilities

• Assist in the coordination and execution of clinical research protocols under the supervision of the PI and senior research staff
• Conduct screening visits to collect medical history & other information from study participants
• Assist with informed consent and enrollment of study participants in accordance with protocol requirements and ethical guidelines
• Coordinate and schedule study visits, procedures, and follow-up activities with study participants and clinical teams
• Collect, record, and maintain accurate clinical research data and source documentation in compliance with regulatory and institutional standards
• Communicate with study participants to provide education, answer questions, and support adherence to study requirements
• Monitor study progress and report adverse events, protocol deviations, and other study-related issues to the research team
• Adhere to site standard operating procedures (SOPs) and Good Clinical Practice (GCP) guidelines
• Draw, process, and ship laboratory specimens, including the handling of dangerous goods, in accordance with regulations (if qualified.)
• Scan, upload, file, and maintain organized study records and documentation
• Apply critical thinking skills to support efficient study operations and problem resolution
• Perform other duties as assigned

Preferred

• an associate's degree or higher in a health-related field
• Basic knowledge of clinical research
• Knowledge of GCP, HIPAA, ALCOA principles, FDA regulations, and IATA guidelines
• Experience with participant screening and the informed consent process
• Proficiency with electronic data capture systems, clinical trial management software, and Microsoft Office (Excel, Word, and PowerPoint)
• Medical Assistant (MA) certification
• Current CPR/BLS certification
• Certification as a Clinical Research Coordinator (e.g., CCRC) or a willingness to obtain certification
• Associate’s degree in health-related field
• Clinical research knowledge
• Clinical Practice (GCP)
• HIPAA knowledge
• ALCOA principles
• FDA regulations
• IATA guidelines
• Participant screening
• Informed consent process
• Electronic data capture systems
• Clinical trial management software
• Microsoft Excel
• Microsoft Word
• Microsoft PowerPoint
• Medical Assistant certification
• CPR/BLS certification
• Clinical Research Coordinator certification

Benefits

• Eligible employees: health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, and voluntary plans
• Eligible employees: participation in a 401(k) plan

Company

• Specialized technical staffing, recruiting, and outsourced workforce solutions.
• Pittsburgh, Pennsylvania, USA
• http://www.systemoneservices.com/
• Founded in 2008
• 5001-10000 employees

Qualifications

• High school diploma or equivalent
• Medical terminology & patient care experience
• Strong organizational, time management, and attention-to-detail skills with the ability to manage multiple priorities
• Ability to communicate clearly and professionally with diverse populations
• Ability to work collaboratively in a fast-paced, team-oriented environment
• An associate's degree or higher in a health-related field
• Basic knowledge of clinical research
• Knowledge of GCP, HIPAA, ALCOA principles, FDA regulations, and IATA guidelines
• Experience with participant screening and the informed consent process
• Proficiency with electronic data capture systems, clinical trial management software, and Microsoft Office (Excel, Word, and PowerPoint)
• Medical Assistant (MA) certification
• Current CPR/BLS certification
• Certification as a Clinical Research Coordinator (e.g., CCRC) or a willingness to obtain certification

Required skills

• Clinical Research, Medical Terminology, Patient Care, Clinical Practice (GCP), HIPAA, ALCOA Principles, FDA Regulations, Participant Screening, Informed Consent, Microsoft Office Excel, Microsoft Office Word, Microsoft Office PowerPoint, CPR/BLS Certification, Certified Clinical Research Coordinator (CCRC)

Preferred skills

• an associate's degree or higher in a health-related field, Basic knowledge of clinical research, Medical Assistant (MA) certification, Current CPR/BLS certification

Experience

• Entry level