Hackensack Meridian Health
Overview
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Clinical Research Coordinator
role at
Hackensack Meridian Health . The Clinical Research Coordinator coordinates and oversees clinical operations of assigned trials, participates in assessment, planning, implementation, and compliance according to regulatory policies.
Responsibilities
Acts as liaison between principal investigators, sub-investigators, clinical research nurses and regulatory specialists on all regulatory issues and changes within the protocol.
Participates in review of studies for feasibility and evaluation of potential competition with other protocols.
Reviews study with principal investigator and/or clinical research nurses to a budget outlining standard of care and research costs. Finalizes budget draft with budget coordinator.
Oversees subject enrollment and ensures informed consent is properly obtained and documented.
Coordinates research activities: scheduling laboratory tests, radiology testing and other medical exams based on protocol.
Drafts and creates study orders, billing templates and study calendars.
Schedules subjects for appointments, procedures, or inpatient stays per protocol.
Monitors all study activities to ensure compliance with protocols and regulatory policies.
Registers protocol patients with appropriate statistical centers as required.
Tracks enrollment status and documents dropout causes.
Communicates with sponsors, IRB, and other medical personnel as needed.
Maintains accurate, complete records on each protocol and patient in the clinical trial management system.
Works closely with clinical research finance to bill study patient activities appropriately.
Prepares for sponsor monitor site visits and keeps documentation records adequate.
Ensures compliant maintenance of all required records of study activity.
Oversees requisition, collection, labeling, storage, or shipment of specimens.
Participates in quality assurance audits and prepares study documentation.
Identifies protocol problems and assists in problem resolution efforts.
Collaborates with investigators to prepare presentations or reports of study procedures, results, and conclusions.
Attends research meetings and conferences as required.
Other duties and/or projects as assigned.
Qualifications Education, Knowledge, Skills and Abilities Required
BA/BS diploma/degree in science or healthcare field.
Minimum of 2 years experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years related experience in clinical research.
Strong attention to detail and customer service focus.
Ability to work independently or in a team, handling multiple deadline-driven tasks in a dynamic environment.
Excellent organizational, presentation, documentation, and interpersonal skills.
Excellent written and verbal communication skills.
Proficient computer skills including Microsoft Office and Google Suite.
Preferred
Education on human subject research and GCP.
SOCRA-Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA), or Certified Clinical Research Coordinator (CCRC).
Compensation & Benefits Minimum rate $82,513.60 annually. The posted rate of pay is a reasonable good faith estimate of the minimum base pay. Pay equity and transparency commitment. Comprehensive benefits package includes health, dental, vision, paid leave, tuition reimbursement, and retirement benefits.
Job Duties: Compensation determination is benchmarked against market data, experience, education, skills, geographic location, internal equity, and budget and grant funding. Performance-based incentives, bonuses, and commissions may be provided. Shift differentials for evening, night, or weekend shifts may apply.
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Clinical Research Coordinator
role at
Hackensack Meridian Health . The Clinical Research Coordinator coordinates and oversees clinical operations of assigned trials, participates in assessment, planning, implementation, and compliance according to regulatory policies.
Responsibilities
Acts as liaison between principal investigators, sub-investigators, clinical research nurses and regulatory specialists on all regulatory issues and changes within the protocol.
Participates in review of studies for feasibility and evaluation of potential competition with other protocols.
Reviews study with principal investigator and/or clinical research nurses to a budget outlining standard of care and research costs. Finalizes budget draft with budget coordinator.
Oversees subject enrollment and ensures informed consent is properly obtained and documented.
Coordinates research activities: scheduling laboratory tests, radiology testing and other medical exams based on protocol.
Drafts and creates study orders, billing templates and study calendars.
Schedules subjects for appointments, procedures, or inpatient stays per protocol.
Monitors all study activities to ensure compliance with protocols and regulatory policies.
Registers protocol patients with appropriate statistical centers as required.
Tracks enrollment status and documents dropout causes.
Communicates with sponsors, IRB, and other medical personnel as needed.
Maintains accurate, complete records on each protocol and patient in the clinical trial management system.
Works closely with clinical research finance to bill study patient activities appropriately.
Prepares for sponsor monitor site visits and keeps documentation records adequate.
Ensures compliant maintenance of all required records of study activity.
Oversees requisition, collection, labeling, storage, or shipment of specimens.
Participates in quality assurance audits and prepares study documentation.
Identifies protocol problems and assists in problem resolution efforts.
Collaborates with investigators to prepare presentations or reports of study procedures, results, and conclusions.
Attends research meetings and conferences as required.
Other duties and/or projects as assigned.
Qualifications Education, Knowledge, Skills and Abilities Required
BA/BS diploma/degree in science or healthcare field.
Minimum of 2 years experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years related experience in clinical research.
Strong attention to detail and customer service focus.
Ability to work independently or in a team, handling multiple deadline-driven tasks in a dynamic environment.
Excellent organizational, presentation, documentation, and interpersonal skills.
Excellent written and verbal communication skills.
Proficient computer skills including Microsoft Office and Google Suite.
Preferred
Education on human subject research and GCP.
SOCRA-Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA), or Certified Clinical Research Coordinator (CCRC).
Compensation & Benefits Minimum rate $82,513.60 annually. The posted rate of pay is a reasonable good faith estimate of the minimum base pay. Pay equity and transparency commitment. Comprehensive benefits package includes health, dental, vision, paid leave, tuition reimbursement, and retirement benefits.
Job Duties: Compensation determination is benchmarked against market data, experience, education, skills, geographic location, internal equity, and budget and grant funding. Performance-based incentives, bonuses, and commissions may be provided. Shift differentials for evening, night, or weekend shifts may apply.
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