Northwell Health Senior Coordinator, Research - Allergy, Clinical Immunology & Rheumatology of Great Neck in Great Neck, New York
Req Number 003F1R
Provides technical and functional expertise in the area of Research. Coordinates the daily activities of a designated study or group of studies. Interprets protocols, makes recommendations for program enhancement initiatives and maintains industry, FDA, and granting agency relationships. Adheres to and assists in the training of research staff on Good Clinical Practice, and regulatory and grant agency requirements. May provide guidance and direction to Research Coordinators and Assistants.
Provides technical and functional expertise in the area of Research studies. Recommends appropriate implementation plan. Monitors study routine to ensure progress of studies and reports to PI or Manager on progress. Oversees compliance with regulatory and granting agencies.
Makes recommendations for program enhancements, performance improvement, and 'best practices.'
Maintains comprehensive study lists for departmental information. Maintains cooperative relations with drug companies and other research centers for information on new research interests.
Oversees 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.
May be required to perform phlebotomy, electrocardiograms, or monitor vital signs on study participants. Educates family and contributes to the care and evaluation of subjects, including determining preliminary inclusion/ exclusion criteria. Reports findings to Manager or PI.
Collects, labels, logs, processes, and ships biological specimens for analysis according to protocol and Haz-Mat Training requirements.
Collaborates with physicians, investigators and other healthcare providers regarding subject care as necessary. Promotes respect for subjects' rights.
Administers, scores and evaluates assessments as assigned and as related to study protocol. Collects data, confers with PI and forwards results to sponsor (internal or external).
Interfaces with the Office of Grants and Contracts (OGC) and Institutional Review Board (IRB) and Clinical Trials Office (CTO). Organizes all phases of grant process for submission to funding agencies as necessary.
Collaborates with PI and acts as a liaison between the Food and Drug Administration and drug companies on related issues. Adheres to and trains research staff on Good Clinical Practice, and regulatory and grant agency requirements. Follows protocol as developed. Keeps investigator informed of protocol changes or developments.
Oversees availability of drug supplies and/or equipment for studies.
Liaises with agencies including: IRB, OCG, pharmaceutical companies, laboratories, and equipment and supply companies as needed.
Performs related duties, as required.
*ADA Essential Functions
Required Experience or qualifications:
Bachelor's Degree, in a field of Science, Behavioral Science or related field, preferred
Minimum of five (5) years progressively responsible related experience.
Certified in Haz-Mat training for packing and shipping, as needed per study protocols, required.
IRB Human Subject Protection training, prior to commencement of research, required.
Certification in venipuncture, electrocardiogram and vital signs, as needed per study protocols, required.
Certified as a Clinical Research Professional, preferred
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