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AMR Clinical · 1 day ago

Research Assistant

Lexington, KY

Full-time

Onsite

New Grad, Entry Level

$20/hr - $23/hr

AMR Clinical is looking for a Research Assistant to support various administrative and clinical tasks at the study site. The role involves ensuring compliance with study protocols, managing study supplies, and assisting with patient interactions during clinical trials.

BiotechnologyHealth CarePharmaceutical

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

Qualification

PhlebotomyClinical Practice (GCP)Medical office experienceAttention to detailTask managementMulti-taskingCommunication skillsOrganizational skills

Required