Description Clin Research Nurse Coordinator
A Brief Overview The Clinical Research Nurse Coordinator, under the guidance and supervision of the Principal Investigator (PI) and Clinical Research Nurse Manager, ensures the integrity and quality of clinical trials are maintained and conducted in accordance w/ federal, state, and local regulations, Institutional Review Board (IRB) approvals, and Holy Name policies and procedures. This position is primarily responsible for the accurate completion of visit procedures and collection of information from study patients according to protocols, and for protecting the health, safety, and welfare of research participants. In addition, the clinical research nurse also acts as a study coordinator for limited studies.
What you will do - Provides nursing care to research study patients
- Ensures compliance with each study's protocol by providing thorough review and documentation at each subject study visit
- Participates in recruitment and selection of study participants by interviewing and documenting medical history to determine compliance with eligibility requirements
- Performs medical tests, including, but not limited to, vital signs, imaging studies, and electrocardiograms, injections and phlebotomy
- Administers investigational medications and performs patient assessments during clinic visits to determine presence of side effects; notifies Principle Investigator of findings/issues
- Provides patient education and medical information to study patients to ensure understanding of proper medication dosage, administration, and disease treatment
- Documents medical data in patient chart, regulatory binder, case report forms and clinical trials management system to capture protocol requirements
- Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), and Good Clinical Practices (GCP) guidelines:
- Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities
- Develops accurate source materials and ensures compliance from site staff
- Provides accurate and timely data collection, documentation, entry, and reporting in both sponsor and Holy Name databases
- Ensures appropriate credentialing and training of the Holy Name research team
- Supports the regulatory staff in the maintenance of regulatory documents in accordance with Holy Name ICR SOP and applicable regulations
- Interfaces with research participants, to support efforts to determine eligibility and consenting of study participants according to protocol
- Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants
- Ensures compliance with research protocols, by providing ongoing quality control audits, including maintaining ongoing investigational drug accountability
- Disburses investigational drug and provides patient teaching regarding administration, as necessary
- Communicates and collaborates w/ study team including internal and external parties, sponsors, PI, and study participants
- Assists in the identification and recruitment of new studies; participates in study start-up inclusive of contracts and budget preparation
Education Qualifications • Bachelor's Degree
BSN
required
Experience Qualifications • 4-6 years
3-5 years of recent clinical nursing experience in a hospital, clinic, or similar health care setting.
Knowledge, Skills, and Abilities • Nursing competency skills per scope of practice (i.e., performing vital signs, nursing assessments, performing ECG/EKG, phlebotomy, administering injections, etc.) Understanding of regulatory requirements such as ICH-GCP, for clinical research
• Detail-oriented and meticulous in all aspects of work
• Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative
• Must have professional demeanor, strong communication skills with the public as well as physicians and co-workers
• Ability to work well independently as well as in team environment
• Strong interpersonal, customer service and multi-tasking skills are critical Proficient in Google Drive and/or Microsoft Office Word and Excel, electronic health systems and databases used in research environment
• Possess the ability to work well under pressure, multi-task, and manage deadlines
• Knowledge of GCP, federal, state, and local regulations, including HIPAA policies and procedures
Licenses and Certifications NJ Nursing License
Upon Hire
required
BLS
Upon Hire
required
At Holy Name, we believe in rewarding every team member with more than a paycheck-we invest in your future and well-being. Full-time and part-time employees have access to a comprehensive benefits package designed to support your health, financial security, and quality of life. We offer low-cost medical coverage with generous employer contributions, dental and vision plans, discounted prescriptions, and access to on-site child care. Additional benefits include 401(k) matching, tuition reimbursement, paid time off, flexible spending accounts, legal and voluntary coverage options, life insurance, and free on-site parking. If you are hired at Holy Name, your final base compensation will be determined based on factors such as employment status (Full/Part-Time or Per Diem) skills, education, and/or experience. In addition to those factors - we believe in the importance of pay equity and consider any internal equity of our current team members as a part of any final offer. Pay Range: $100,006.40-$119,995.20
Holy Name is a mission-driven facility whose quality standards and philosophy are rooted in the principles of its founders, the Sisters of St. Joseph of Peace. Those principles are exercised daily by the Medical Center's dedicated and talented staff members.
