Clinical Research Nurse I

Job Description

Job Description

Job Title: Clinical Research Nurse I

Job Description

The Clinical Research Nurse I plays a key role in supporting clinical trials by coordinating protocol activities, managing regulatory submissions, and serving as a primary point of contact for study participants. This role combines direct patient interaction with meticulous documentation and regulatory compliance to ensure that clinical research studies run safely, ethically, and efficiently.

Responsibilities

• Facilitate the preparation, submission, and maintenance of Institutional Review Board (IRB) protocol applications and related regulatory documents.
• Draft, review, and update informed consent forms to ensure they meet regulatory, ethical, and institutional requirements.
• Identify, recruit, and screen potential study participants in alignment with protocol eligibility criteria.
• Serve as a key contact for patients throughout the entire study, providing education, support, and ongoing communication.
• Coordinate and schedule patient visits and study-related procedures based on protocol requirements and patient availability.
• Complete and maintain all study documents and source records in accordance with institutional policies, sponsor guidelines, and FDA regulations.
• Manage clinical research data, including accurate data entry into electronic data capture (EDC) systems and timely query resolution.
• Support start-up (SSU) activities for clinical trials, including collection and organization of regulatory and site activation documents.
• Assist with the conduct of drug or device trials, including neurology-focused studies, while adhering to Good Clinical Practice (GCP) standards.
• Collaborate with investigators, coordinators, and other research staff to ensure protocol adherence and high-quality study conduct.
• Utilize the electronic health record (such as Epic) to review patient information, document study-related activities, and support patient recruitment.
• Ensure that all research activities comply with Health System policies, sponsor requirements, and applicable regulatory guidelines.

Essential Skills

• Graduation from an accredited Registered Nurse (RN) program.
• Active New Jersey RN (NJ-RN) license.
• Experience or strong familiarity with clinical research and clinical trial processes.
• Knowledge of IRB processes, including protocol and informed consent submissions.
• Ability to manage and maintain regulatory documentation in compliance with institutional, sponsor, and FDA requirements.
• Experience with patient recruitment and interaction in a clinical or research setting.
• Proficiency in clinical data management, including accurate and timely data entry.
• Working knowledge of Good Clinical Practice (GCP) guidelines.
• Ability to use electronic health record systems, such as Epic, for research-related activities.
• Advanced understanding and use of Microsoft Office applications (e.g., Word, Excel, Outlook).

Additional Skills & Qualifications

• Certification in clinical research (such as a clinical research coordinator or clinical research nurse certification) preferred.
• Experience with electronic data capture (EDC) systems.
• Experience in drug or device trials, including neurology studies, is highly advantageous.
• Experience with site start-up (SSU) activities for clinical trials.
• Strong organizational skills with the ability to manage multiple studies and priorities.
• Excellent written and verbal communication skills for effective interaction with patients, investigators, and study sponsors.

Work Environment

This position follows a hybrid schedule with four days on site and one day remote, depending on patient scheduling and study needs. The role is primarily based in a clinical research environment within a health system, involving regular interaction with patients, investigators, and multidisciplinary research teams. The nurse uses technologies such as electronic health records (e.g., Epic), electronic data capture platforms, and Microsoft Office to support study operations and documentation. Work involves a mix of office-based tasks, chart review, and direct patient engagement in clinical areas, requiring attention to detail, confidentiality, and adherence to research protocols and institutional policies.

This is a Permanent position based out of Camden, NJ.

The pay range for this position is $70000.00 - $93600.00/yr.

-benefits-eligible-and-payroll

This is a fully onsite position in Camden,NJ.

This position is anticipated to close on Jun 5, 2026.

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