Job Title: Clinical Research Nurse I
Job Description
The Clinical Research Nurse I supports and coordinates clinical research studies by managing regulatory documentation, facilitating institutional review board submissions, and guiding patients through every stage of participation. This role combines direct patient interaction with meticulous data and document management to ensure full compliance with health system, sponsor, and regulatory requirements. The nurse plays a central role in patient recruitment, informed consent, and ongoing study coordination for drug and device trials, with a particular focus on neurology research.
Responsibilities
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Facilitate the preparation, submission, and maintenance of institutional review board (IRB) protocols and related documentation.
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Draft, update, and manage informed consent forms in alignment with regulatory and institutional requirements.
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Identify, recruit, and screen potential study participants in accordance with protocol inclusion and exclusion criteria.
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Serve as a primary point of contact for patients throughout the entire study, providing education, support, and follow-up.
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Complete, organize, and maintain all study-related documents in compliance with health system policies, sponsor requirements, and FDA regulations.
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Coordinate and manage site start-up (SSU) activities to ensure timely activation of clinical trials.
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Support the conduct of drug and device trials, including neurology-focused studies, by adhering to Good Clinical Practice (GCP) standards.
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Enter, verify, and manage clinical trial data using electronic data capture (EDC) systems and other designated platforms.
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Utilize the electronic medical record system (such as Epic) to review, document, and track patient information relevant to study participation.
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Collaborate with investigators, study coordinators, and other research staff to ensure protocol adherence and data integrity.
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Monitor patient safety by tracking adverse events and promptly reporting findings in accordance with regulatory and sponsor guidelines.
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Assist with regulatory correspondence and ongoing reporting requirements to IRBs, sponsors, and other oversight bodies.
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Use Microsoft Office applications to prepare reports, maintain logs, and support study documentation and communication.
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Contribute to continuous improvement of research processes by following established procedures and suggesting enhancements when appropriate.
Essential Skills
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Active Registered Nurse (RN) license in the state of New Jersey (NJ-RN License).
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Graduation from an accredited Registered Nurse (RN) program.
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Experience in clinical research and clinical trials, including involvement in drug or device trials required.
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Knowledge of regulatory requirements related to clinical research, including IRB processes and FDA expectations.
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Experience with patient recruitment and engagement in a clinical or research setting.
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Familiarity with IRB procedures and documentation requirements.
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Experience with site start-up (SSU) management for clinical trials.
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Ability to manage and maintain study documents in compliance with health system, sponsor, and regulatory standards.
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Proficiency with electronic medical record systems, such as Epic.
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Experience using electronic data capture (EDC) systems for clinical trial data management.
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Knowledge of Good Clinical Practice (GCP) guidelines and their application in clinical research.
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Advanced understanding of Microsoft Office applications (such as Word, Excel, and Outlook) for documentation and communication.
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Strong organizational skills and attention to detail for managing multiple studies and documentation requirements.
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Effective communication and interpersonal skills for interacting with patients, investigators, and research staff.
Additional Skills & Qualifications
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Clinical research certification (such as CCRP or similar) is preferred.
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Experience working on neurology-focused clinical trials is beneficial.
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Prior involvement in both drug and device clinical trials is an advantage.
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Experience coordinating with multiple stakeholders, including sponsors, monitors, and regulatory bodies.
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Ability to adapt to changing study needs and timelines in a fast-paced research environment.
Work Environment
This role follows a hybrid work schedule, with four days on site and one day remote each week. The position operates within a structured clinical research setting that supports drug and device trials, including neurology studies, and uses technologies such as electronic medical records (e.g., Epic), electronic data capture systems, and Microsoft Office applications. The work environment emphasizes regulatory compliance, documentation accuracy, and collaborative teamwork. The schedule offers flexibility, with leadership demonstrating a supportive and adaptable approach to balancing on-site and remote responsibilities.
Job Type & Location
This is a Permanent position based out of Camden, NJ.
Pay and Benefits
The pay range for this position is $75000.00 - $120000.00/yr.
https://www.cooperhealth.org/welcome/benefits-benefits-eligible-and-payroll
Workplace Type
This is a fully onsite position in Camden,NJ.
Application Deadline
This position is anticipated to close on Jun 24, 2026.
About Actalent
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