Clinical Research Coordinator

Overview

Coordinates all aspects of clinical trials, ensuring compliance with ICH, GCP and protocol.

Key Responsibilities

• subject screening
• visit coordination
• safety assessments
• drug accountability
• source documentation
• adverse event reporting

Tasks

-Screening and enrolling activities: Assists in reviewing all participant history from Pre-Enrollment and Enrollment departments confirming information with potential participant and study physician. -Assists investigators in collection of information from study subjects regarding AEs (Adverse Events), concomitant medications and other changes throughout participation. -Collaborates with the research pharmacist to perform drug accountability and compliance at each visit and educating subject on proper dosing regimen. -Coordinates scheduled visits, adhering to protocol visit windows and timelines. -Timely reporting of study status, study related issues, and study events (SAEs (serious adverse events), protocol deviations, etc) to appropriate management, internal departments and other outside agencies (Sponsors, CRO’s (contract research organization), etc.) -Maintains professional and appropriate interactions with study subjects, caregivers, sponsors and all other study related personnel, and staff members. -Study start-up activities: Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.). -Study start-up activities: Participates in IMs (Inclusion Management) and SIVs (Site Initiation Visits); communicating with sponsors and representatives. -Coordinates all aspects of patient involvement from study initiation until study completion. -Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). -Responsible for subject scheduling and follows subjects through study completion and creates follow-up care plan with physician, study subject and primary care provider. -Prepares and facilitates all study monitoring visits and follows up promptly with monitor follow-up letters. -Screening and enrolling activities: Educates potential participants and caregivers on protocol specific details and expectations. -Study start-up activities: Assists in the creation of thorough and accurate source documents. -Communicates closely with all departments to ensure study visits are coordinated in compliance with protocol and GCP guidelines. -Study start-up activities: Works collaboratively with internal departments, sponsors and investigators to ensure protocols are understood and assists in training staff members. -Accurate and timely completion of source documents recording subject’s participation in study. -Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. -Screening and enrolling activities: Works with the physician to address all questions and concerns related to the trial and informed consent process.

Requirements

• medical terminology
• regulatory
• medical equipment
• technology
• leadership
• communication

What You Bring

-Knowledge of medical terminology. -Works independently as well as functioning as part of a team. -Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. -Strong leadership and mentorship skills. -Experience with medical equipment and instruments to administer study subject care. -High level of ability to complete paperwork with precision, accuracy, and attention to detail; meet timelines; and prioritization. -Screening and enrolling activities: Maintains thorough knowledge of study specific inclusion/exclusion criteria. -Must be able to effectively communicate verbally and in writing. -Prompt and professional communication with sponsors, representatives and other study related parties. -Proficient in the use of technology required for the completion of study visits and study conduct. -Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations.

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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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