Medical Assistant - Clinical Research

Responsibilities

• 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.
• Assist in participant recruitment by prescreening electronic medical records, following up on referrals, and coordinating outreach efforts.
• 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.
• Absorb and process participant stipends.
• 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.
• 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.
• Absorb and complete case report forms (CRFs) under study coordinator guidance.
• 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.
• Absorb and assist with onsite or remote clinical research monitor visits.

Requirements

• Bachelor's degree OR 2 years of college in a health-related program OR completion of a medical assistant, phlebotomist, or other healthcare-related program OR experience and training in conducting clinical trials with knowledge of ICH GCP required.
• Certification as a Medical Assistant required.
• Experience with medical terminology and laboratory procedures helpful.
• Strong attention to detail, with the ability to collect, compile, and analyze patient data accurately.
• Excellent interpersonal, communication (verbal and written), and customer service skills.
• Easily able to learn new computer or website applications (i.e. Electronic Medical Records, Clinial Trial Management Systems, etc.).
• Proven ability to prioritize tasks, meet deadlines, and adapt to a fast-paced work environment.
• Problem-solving skills with a proactive and solution-oriented approach.
• Strong organizational skills with the proven ability to prioritize tasks and meet strict deadlines.
• Phlebotomy training and experience heavily preferred; willingness to become fully trained required.