Hackensack Meridian Health

The Research Nurse Coordinator is responsible for ensuring that the clinical research is conducted according to the research design including but not limited to screening and recruitment of patients, collecting and records of clinical data, maintaining regulatory binders and overall safety of human subjects.. Facilitates all audits of study with staff of JFK Medical Center, sponsor, FDA, and other regulatory agencies.. Assists investigator with consent process assuring patients understand clinical trials.. Mandatory education on human subject research and GCP (CITI Training and Certification).. Certified Clinical Research Professional or Society of Clinical Research Associates Certification or Certified Clinical Research Coordinator.

nurse coordinator

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 Nurse Coordinator is responsible for ensuring that the clinical research is conducted according to the research design including but not limited to screening and recruitment of patients, collecting and records of clinical data, maintaining regulatory binders and overall safety of human subjects.

Responsibilities:
A day in the life of a Research Nurse Coordinator at Hackensack Meridian Health includes: <ul><li>Assists in the preparation of new protocols.</li><li>Assures that all protocol revisions, informed consents, continuing reviews, and serious adverse events are reported in a timely manner.</li><li>Acts as a liaison between principal investigators and sub-investigators on all regulatory issues and changes within the protocol. </li><li>Facilitates all audits of study with staff of JFK Medical Center, sponsor, FDA, and other regulatory agencies. </li><li>Reviews studies for feasibility and for competing protocols prior to submitting study. </li><li>Reviews study with principal investigator to determine standard vs. research costs and assists in budget preparation as needed. </li><li>Screens subjects/patients for entry criteria, coordinates subject/patient schedules with investigators, and protocol schedules. </li><li>Performs vital signs and handles and ships lab specimens as outlined in the clinical program. </li><li>Assists investigator with consent process assuring patients understand clinical trials. </li><li>Monitors response to treatment and for any adverse events.</li><li>Reports all serious adverse events to sponsor and IRB.</li><li>Maintains accurate, complete, up-to-date records on each patient participating in a clinical protocol. </li><li>Prepares for sponsor monitor visits and ensures all supporting documentation records are adequate available for the visit. </li><li>Develops case report forms and/or databases for in-house studies as needed. </li><li>Assists the principal investigator in data collection for writing abstracts, papers, and presentations. </li><li>Provides education to all departments and clinical areas where study is performed. </li><li>Adheres to the American Nurses Association standards. </li><li>Identified the needs of the patient population served and modifies and delivers the care that is specific to those needs (i.e., age, culture, hearing and/or visually impaired, etc.). This process includes communicating with the patient, parent, and/or primary caregiver(s) at their level (developmental/age, education, literacy, etc.). </li><li>Share clinical trials call schedule per department needs. </li><li>Adheres to the standards identified in the Medical Center's Organizational Competencies. </li><li>Other duties and/or projects as assigned. </li><li>Adheres to HMH Organizational competencies and standards of behavior.</li></ul> 

Qualifications:
Education, Knowledge, Skills and Abilities Required: <ul><li style="border: none;">Graduate of an NLN/AACN accredited program in nursing. </li><li style="border: none;">Minimum of 3-5 years clinical nursing experience.</li><li style="border: none;">General knowledge of office activities. </li><li style="border: none;">Computer literate. </li><li style="border: none;">MS Word/Excel/PowerPoint, Google Workspace, and applicable software applications. </li></ul>Education, Knowledge, Skills and Abilities Preferred: <ul><li>Masters in Clinical Research; or a similar field. </li><li>Mandatory education on human subject research and GCP (CITI Training and Certification).</li><li>Knowledge of clinical trials and the regulation (local, state, and federal) of such. </li><li>Database management experience. </li><li>General knowledge of grant mining.</li></ul> Licenses and Certifications Required: <ul><li>NJ State Professional Registered Nurse License.</li></ul> Licenses and Certifications Preferred: <ul><li>Certified Clinical Research Professional or Society of Clinical Research Associates Certification or Certified Clinical Research Coordinator.</li></ul> If you feel that the above description speaks directly to your strengths and capabilities, then please apply today!

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