Site Research Assistant - Pittsburgh, PA

About the role

We are seeking a detail-oriented and motivated Research Assistant (RA) to support clinical research studies under the direction of the Principal Investigator. This role offers hands-on involvement in clinical procedures, participant engagement, and study coordination, while ensuring compliance with regulatory and quality standards.

Key Responsibilities

• Perform accurate EDC data entry, manage data queries, and ensure timely resolution.
• Maintain and update regulatory binders in compliance with documentation and audit requirements.
• Coverage and schedule participant visits, procedures, and follow-up activities.
• Support participant screening, recruitment, and enrollment efforts.
• Aid in patient scheduling, reminders, and collection of medical history.
• Conduct patient chart reviews and pre-screening activities to identify eligible participants.
• Coordinate laboratory procedures and ensure proper follow-up care per study protocols.
• Ensure strict adherence to IRB-approved protocols, including support during informed consent processes.
• Build effective working relationships with investigators, clinical staff, and study team members.
• Ensure participant safety and promptly report concerns in accordance with SOPs and sponsor requirements.
• Follow all company policies, SOPs, guidelines, and Good Clinical Practice (GCP) standards.

Qualifications

• Associate degree preferred, or equivalent combination of education and relevant experience.
• At least 1 year of experience in a clinical research environment preferred.
• Working knowledge of clinical trials, GCP, and protocol-specific procedures.
• Proficiency in EDC systems, including data entry and query resolution.
• Experience with participant scheduling, regulatory documentation, and binder maintenance.
• Ability to conduct patient chart review and pre-screening procedures.
• Strong attention to detail, organizational skills, and ability to prioritize tasks effectively.
• Excellent communication, interpersonal, and relationship-building skills.

Additional Information

Please note: This position is not eligible for sponsorship.