Clinical Research Coordinator

Job Description:

The Laboratory Coordinator plays a crucial role in the execution of clinical lab testing protocols, and new assay and new instruments validation and verification. The coordinator manages the labs quality assurance activities, necessary to our continuous improvement and leading to the highest levels of laboratory performance and practices

Job Responsibility

• Responsible for coordination of a designated study or group of studies.
• In research projects, oversees recruitment of subjects, implementation of study procedures, and the collection and processing of data.
• Keeps accurate and up-to-date records.
• Collects labels, logs, processes, and ships biological specimens for analysis according to protocol and training requirements.
• Schedules subjects for protocol-related evaluations; collaborates with physicians, investigators and other healthcare providers; promotes respect for subjects’ rights.
• Administers, scores and evaluates results of assessments as assigned and as related to study protocol; collects data, confers with PI and forwards results to sponsor (internal or external).
• Interfaces with external agencies as necessary; organizes all phases of grant process for submission to funding agencies as necessary.
• Ensures availability of drug supplies and/or equipment for studies; maintains drug accountability logs.
• Liaisons with agencies and pharmaceutical companies, laboratories, and equipment and supply companies, as needed.
• Adheres to good clinical practice, and complies with regulatory and grant agency requirements; follows protocol as developed and keeps investigator or supervisor informed of developments.
• Collaborates with PI and the food and drug administration and drug companies on related issues; may be required to perform phlebotomy, electrocardiograms, or monitor vital signs on study participants and report findings to supervisor.
• Operates under general guidance and work assignments are varied and require interpretation and independent decisions on course of action.
• Performs related duties as required. All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act. Duties not mentioned here, but considered related are not essential functions.
• The coordinator will help to perform the assay validation, create new assay SOPs and instrument maintenance charts.
• Responsible for the data collection, analysis and interpretation of data related to specific project. Oversee and maintain the surveillance report of infectious disease.
• The individual will assist to perform complex laboratory procedures in order to analyze clinical samples; this will require extensive, accurate, and efficient hands-on work.
• Attention to detail, strict adherence to protocols, maintenance of extensive and accurate documentation is expected.
• Compile, analyze and document procedures performed. Operate, maintain, calibrate, and troubleshoot complex equipment.
• Follow-up and troubleshoot un-expected data

Job Qualification

• Bachelor's Degree required, or equivalent combination of education and related experience.
• 1-3 years of relevant experience, required.