Research Assistant

Primary Responsibilities

• Effectively prioritize tasks and meet deadlines in a fast-paced environment.
• Maintain a strong emphasis on compliance responsibilities, including timely identification and reporting of protocol deviations, serious adverse events (SAEs), and adherence to regulatory and site-specific requirements.
• Monitor & Report Adverse Events – Recognize and promptly report AEs, protocol deviations, and safety concerns to the clinical team. Document AEs and Serious Adverse Event reporting in compliance with FDA, IRB, and sponsor requirements, ensuring timely follow-up and resolution.
• Ensure Compliance with Study Protocols & Regulatory Guidelines – Adhere to Good Clinical Practice (GCP), FDA regulations, and site SOPs when conducting study-related activities.
• Assist in Subject Retention Efforts – Support ongoing engagement, communication, and compliance to enhance subject retention throughout the study.
• Perform Inventory Management – Track and manage study supplies, lab kits, and investigational products (if applicable) to ensure readiness for study visits.
• Assist in maintaining accurate, timely, and audit-ready documentation of all study-related activities.
• Perform Laboratory Responsibilities with Accuracy – Ensure proper labeling, handling, storage and shipment of specimens per protocol and regulatory requirements.
• Strong problem-solving skills and ability to adapt to evolving study requirements.
• Ability to handle confidential and sensitive information with discretion.
• Ability to follow detailed instructions and maintain high levels of accuracy.
• Establish and maintain patient rapport during clinical drug trials to include management of subjects: Clinical data collection such as vital signs, EKG recording, subject weights, etc.; Medical record retrieval and review when required; Subject interviews; Phlebotomy; Filing and pulling study records; Answering and triage of research office calls; Subject check in and out process.
• Study preparation, such as screening packets, preparing informed consents, pulling charts for the next business day, etc.
• Filing study documents in the subject’s chart.
• Develop rapport with study sponsors, monitors, study participants, etc.
• Assist monitors during onsite visits.
• Maintain accurate enrollment/ICF logs.
• Assist the clinical team to complete study activities. The clinical team includes but is not limited to CRCs, Laboratory, Data management, etc.
• Educate subjects on diaries as studies require.
• Accurate and timely documentation.
• Unblinded duties as assigned.
• Position may require occasional weekend and/or overtime hours.
• Other duties as assigned.

Desired Skills and Qualifications

• Medical office experience, medical certificate, or equivalent work experience preferred.
• Phlebotomy skills are preferred.
• Excellent attention to detail.
• Strong listening, verbal and written communication skills.
• Excellent task management and organizational skills.
• Ability to multi-task in an always evolving fast paced environment.
• Demonstrate proficient knowledge of operating office equipment and software.
• Ability to be ambulatory most of the workday.
• Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination.
• Fluent in English.