Clinical Research Coordinator

Overview

Coordinate patient involvement in clinical trials from start to completion.

Key Responsibilities

• drug accountability
• safety assessments
• source documentation
• visit coordination
• study reporting
• participant education

Tasks

-Educate potential participants and caregivers on protocol-specific details and expectations. -Collaborate with the research pharmacist to perform drug accountability and compliance at each visit and educate subjects on proper dosing regimen. -Ensure site receives accurate information and supplies from sponsors. -Assist investigators in the collection of information from study subjects regarding Adverse Events (AEs), concomitant medications, and other changes throughout participation. -Coordinate all aspects of patient involvement from study initiation until study completion. -Communicate closely with all departments to ensure study visits are coordinated in compliance with protocol and GCP guidelines. -Participate in Inclusion Management (IM) and Site Initiation Visits (SIVs), communicating with sponsors and representatives. -Maintain professional and appropriate interactions with study subjects, caregivers, sponsors, and all other study-related personnel and staff members. -Prepare and facilitate all study monitoring visits and promptly follow up with monitor follow-up letters. -Work with the physician to address questions and concerns related to the trial and informed consent process. -Assist in reviewing participant history and confirm information with potential participants and study physicians during screening and enrolling activities. -Perform safety and efficacy assessments per protocol, including vital signs, EKGs, blood draws, and other assessments as assigned. -Ensure accurate and timely completion of source documents recording subject’s participation in the study. -Assist in the creation of thorough and accurate source documents during study start-up activities. -Collaborate with internal departments, sponsors, and investigators to ensure protocols are understood and assist in training staff members. -Coordinate scheduled visits, adhering to protocol visit windows and timelines. -Responsible for subject scheduling and follow subjects through study completion, creating a follow-up care plan with the physician, study subject, and primary care provider. -Report study status, study-related issues, and study events to appropriate management, internal departments, and other outside agencies in a timely manner.

Requirements

• clinical trials
• ekg
• bilingual
• ms office
• phlebotomy
• communication

What You Bring

-Experience with interventional clinical trials. -Understanding of EKG and patient visit protocols. -Bilingual in English and Spanish. -Maintain thorough knowledge of study-specific inclusion/exclusion criteria. -Knowledge of medical terminology. -Proficiency in Microsoft Word and Excel. -Effective verbal and written communication skills. -Phlebotomy skills are a plus. -Experience with PI/monitor interaction.

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Benefits

-The role is fully on-site from Monday to Friday, following traditional business hours from 8:00 AM to 4:30 PM.

About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

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