Clinical Research Assistant

The Role

The Research Assistant is a vital member of the clinical research team, working under the supervision of the Site Director, Principal Investigator, and Clinical Research Coordinators (CRCs). This role supports the day-to-day operations of clinical trials by ensuring compliance with regulatory requirements and assisting in the smooth execution of study activities. The Research Assistant is integral in maintaining the integrity of data collection, patient care, and adherence to study protocols, contributing to advancements in clinical research.

Responsibilities

• Study Preparation
• Prepare and maintain study documents, including source charts, study binders, regulatory binders, and laboratory kits.
• Schedule and confirm subject appointments, including ancillary visits such as diagnostic imaging and vendor-related services.
• Understand study protocols, inclusion/exclusion criteria, and regulatory requirements, ensuring compliance with FDA, Sponsor, and Good Clinical Practice (GCP) guidelines.
• Aid in participant recruitment by prescreening electronic medical records, following up on referrals, and coordinating outreach efforts.
• Participant Care and Interaction
• Provide subject care, including explaining study procedures, answering questions, and monitoring diary compliance.
• Conduct study procedures, such as collecting vital signs, performing ECGs, and completing study questionnaires.
• Perform follow-up and reminder calls to ensure subject adherence to visits and study protocols.
• Aid in participant stipend tracking and processing.
• Laboratory and Specimen Handling
• Perform blood draws (phlebotomy) and process biological samples, including shipping per study requirements.
• Maintain laboratory equipment, supplies, and temperature control systems, ensuring compliance with study protocols.
• Generate and file weekly temperature reports for laboratory systems.
• Data Entry and Management
• Enter and verify study data in Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), and other databases.
• Address system-generated queries and perform quality control checks to ensure data accuracy and completeness.
• Aid in case report forms (CRFs) and source document completion, including query resolution under study coordinator guidance.
• Administrative and General Support
• Maintain and organize participant charts, Investigator Site Files, and other regulatory documents.
• Support clinical research coordinators (CRCs) by filing, scanning, and faxing required documents.
• Clean, stock, and maintain exam rooms and department supplies to ensure readiness for participant visits.
• Participate in investigator meetings, study teleconferences, and trainings.
• Aid in onsite or remote clinical research monitor visits.

Requirements

• Bachelor’s degree preferred or equivalent experience;
• 1+ year of experience within a clinical research or healthcare environment.
• Medical Knowledge: Familiarity with medical terminology, lab procedures, and research protocols preferred.
• Attention to Detail: Ability to collect, compile, and analyze data accurately.
• Communication & Customer Service: Strong interpersonal, verbal, and written communication skills.
• Technical Skills: Proficiency in Microsoft Office and Electronic Data Capture (EDC) systems.
• Adaptability & Problem-Solving: Ability to prioritize tasks, meet deadlines, and work in a fast-paced environment.
• Collaboration & Independence: Comfortable working both independently and within a team.
• Compliance & Confidentiality: Understanding of HIPAA, FDA, GCP, and ICH guidelines (preferred).
• Research & Lab Skills: Basic computer literacy, with lab skills (e.g., blood draws, specimen processing) preferred.
• Certifications (Preferred): BLS/CPR, CNA, CMA, or similar certification.