JFK Johnson Rehabilitation Institute
SENIOR CLINICAL RESEARCH COORDINATOR
JFK Johnson Rehabilitation Institute, Hackensack, New Jersey, us, 07601
Overview
Hackensack Meridian Health is seeking a Senior Clinical Research Coordinator at Hackensack University Medical Center in Hackensack, New Jersey. The Senior CRC coordinates and oversees clinical operations of all assigned clinical trials and ensures compliant study conduct according to regulatory requirements and institutional policies and SOPs. The role reports to the principal investigator and may provide back-up Project Manager support and serve as preceptor/trainer for new Clinical Research Coordinators. Responsibilities
Precept and train Clinical Research Coordinators. Provide backup coverage for Project Manager as needed. Design, develop, and coordinate clinical trial workflows and assist with implementation. Serve as main contact for sponsors and internal departments to ensure quality data collection and trial conduct, including audit responses. Act as liaison among investigators, sub-investigators, clinical research nurses and regulatory specialists on regulatory issues. Participate in feasibility review and evaluation of competing protocols. Review study budgets and finalize budget drafts with the budget coordinator. Review proposed protocols for data management, sample collection, and subject risks; oversee enrollment and informed consent. Coordinate research activities (scheduling labs, imaging, and other exams). Draft study orders, billing templates, and study calendars; schedule subjects for visits. Monitor regulatory compliance and manage study records in trial management systems. Register protocol patients with statistical centers as required; track enrollment and dropout information. Represent the principal investigator in communications with sponsors, IRB, and other medical personnel as appropriate. Maintain accurate, up-to-date records for each protocol and patient. Collaborate with clinical research finance to ensure proper billing for trial activities. Prepare for sponsor monitor visits and address findings; coordinate site visits with sponsors. Maintain sponsor communications and respond to questions about data issues. Ensure compliant maintenance of study records (CRFs, drug dispensation, regulatory forms). Oversee specimen handling and shipment. Participate in QA audits and prepare study-related documentation. Identify protocol problems and assist in resolution, including protocol revisions. Organize space for study equipment; contribute to protocol development and data collection guidelines. Contact external health care providers and obtain follow-up information. Engage in continuing education and attend meetings to stay current on clinical studies. Collaborate with investigators to prepare presentations or reports; attend meetings and in-service education. Other duties as assigned; adhere to organizational competencies and standard of behavior. Qualifications
BA/BS in science or healthcare field. Minimum of 2 years experience as a Clinical Research Coordinator, or at least 6 years related clinical research experience. Strong attention to detail and customer service focus. Ability to work independently or in a team; handle multiple deadline-driven tasks. Excellent organizational, presentation, documentation, and interpersonal skills. Excellent written and verbal communication skills. Proficient in Microsoft Office and/or Google Suite. Education, Knowledge, Skills and Abilities Preferred
Education on human subject research and GCP. Licenses And Certifications Preferred
SOCRA-CCR(P) or similar certifications (CCRP, CCRA, CCRC). Compensation: Starting at $82,513.60 annually. Hackensack Meridian Health is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, or other protected characteristics.
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Hackensack Meridian Health is seeking a Senior Clinical Research Coordinator at Hackensack University Medical Center in Hackensack, New Jersey. The Senior CRC coordinates and oversees clinical operations of all assigned clinical trials and ensures compliant study conduct according to regulatory requirements and institutional policies and SOPs. The role reports to the principal investigator and may provide back-up Project Manager support and serve as preceptor/trainer for new Clinical Research Coordinators. Responsibilities
Precept and train Clinical Research Coordinators. Provide backup coverage for Project Manager as needed. Design, develop, and coordinate clinical trial workflows and assist with implementation. Serve as main contact for sponsors and internal departments to ensure quality data collection and trial conduct, including audit responses. Act as liaison among investigators, sub-investigators, clinical research nurses and regulatory specialists on regulatory issues. Participate in feasibility review and evaluation of competing protocols. Review study budgets and finalize budget drafts with the budget coordinator. Review proposed protocols for data management, sample collection, and subject risks; oversee enrollment and informed consent. Coordinate research activities (scheduling labs, imaging, and other exams). Draft study orders, billing templates, and study calendars; schedule subjects for visits. Monitor regulatory compliance and manage study records in trial management systems. Register protocol patients with statistical centers as required; track enrollment and dropout information. Represent the principal investigator in communications with sponsors, IRB, and other medical personnel as appropriate. Maintain accurate, up-to-date records for each protocol and patient. Collaborate with clinical research finance to ensure proper billing for trial activities. Prepare for sponsor monitor visits and address findings; coordinate site visits with sponsors. Maintain sponsor communications and respond to questions about data issues. Ensure compliant maintenance of study records (CRFs, drug dispensation, regulatory forms). Oversee specimen handling and shipment. Participate in QA audits and prepare study-related documentation. Identify protocol problems and assist in resolution, including protocol revisions. Organize space for study equipment; contribute to protocol development and data collection guidelines. Contact external health care providers and obtain follow-up information. Engage in continuing education and attend meetings to stay current on clinical studies. Collaborate with investigators to prepare presentations or reports; attend meetings and in-service education. Other duties as assigned; adhere to organizational competencies and standard of behavior. Qualifications
BA/BS in science or healthcare field. Minimum of 2 years experience as a Clinical Research Coordinator, or at least 6 years related clinical research experience. Strong attention to detail and customer service focus. Ability to work independently or in a team; handle multiple deadline-driven tasks. Excellent organizational, presentation, documentation, and interpersonal skills. Excellent written and verbal communication skills. Proficient in Microsoft Office and/or Google Suite. Education, Knowledge, Skills and Abilities Preferred
Education on human subject research and GCP. Licenses And Certifications Preferred
SOCRA-CCR(P) or similar certifications (CCRP, CCRA, CCRC). Compensation: Starting at $82,513.60 annually. Hackensack Meridian Health is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, or other protected characteristics.
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