**Overview** Our team members are the heart of what makes us better. At **Hackensack Meridian** **_Health_** we help our patients live better, healthier lives — and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It’s also about how we support one another and how we show up for our community. Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change. The **Research Coordinator** coordinates and performs all the associated duties associated with coordination and implementation of the conduct of clinical research trials and projects. **Responsibilities** A day in the life of a **Research Coordinator** at Hackensack Meridian _Health_ includes: + Assists and conducts literature review, appraisal and grading of evidence and collaborates on proposal development + Assists in the preparation and submission to institutional review board application. + May act as a liaison between Institutional Review Board(s) principal investigators, sub-investigators, assuring compliance with regulatory and institutional mandates and regulations inclusive of but not limited to amendments to protocols and/or modifications to study design as appropriate. + Reports all serious adverse events to sponsor and IRB(s). + Serves as primary study coordinator ensuring adherence to the research protocol and provides periodic updates to Principal Investigator on study progress. + Assists in the development of forms, questionnaires, and completes case report forms and maintains source document + May create and maintain regulatory binders and files for assigned protocols + Collaborates with the research nurse coordinator in creating source documents + Screens research subject /participants as delineated in study specific eligibility criteria + Obtains informed consent + Assures follow-up on all protocol patients by maintaining updated records, reviewing active patient lists for correct and current materials, and co-investigators of diagnostic tests needed for protocol compliance. + Performs periodic quality assurance audits to ensure completeness and accuracy of study documents + Collects data collection, data validation and verification through and continually monitors to assure, investigates and resolves discrepancies. + Maintains a thorough knowledge of all aspects of protocol including primary clinical aim, method of protocol execution, budgetary and logistic components and contractual requirements. + Facilitates all audits with staff of HMH, sponsor, FDA and other regulatory agencies. + Must continually seek and attend educational venues related to governmental regulations, research and data management. + Identifies the needs of the patient population served and provides service that is specific to those needs (i.e. culture, language, hearing and/or visually impaired, etc.). This process includes communicating with the patient, parent and/or primary caregiver(s) at their level (developmental/age, educational, literacy, etc.). + May be required to draw blood for sample collection. + Other duties and/or projects as assigned. + Adheres to HMH Organizational competencies and standards of behavior. **Qualifications** **Education, Knowledge, Skills and Abilities Required** : + Bachelor's degree or equivalent work experience and High School diploma, general equivalency diploma (GED), GED equivalent programs, and/or other Vocational degrees/certificates. + Minimum of 1 or more years of experience in clinical research/regulatory experience or equivalent. + Mandatory education on human subject research. + Excellent written and verbal communication skills. + Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms. **Licenses and Certifications Preferred** : + Association for Clinical Research Professionals Certification. If you feel that the above description speaks directly to your strengths and capabilities, then please apply today! **Job ID** _2024-153193_ **Department** _Cardio Vascular Research_ **Site** _Hackensack University Med Cntr_ **Job Location** _US-NJ-Hackensack_ **Position Type** _Full Time with Benefits_ **Standard Hours Per Week** _40_ **Shift** _Day_ **Shift Hours** _8:30 a.m. - 5:00 p.m._ **Weekend Work** _No Weekends Required_ **On Call Work** _No On-Call Required_ **Holiday Work** _No Holidays Required_