Clinical Trials & Regulatory Manager (NP/PA)

Job Description

Reports to: Executive Director / Director of Operations

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A Research Leadership Opportunity for an NP or PA

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Are you a Nurse Practitioner or Physician Assistant with substantial clinical research experience who wants to make research leadership—not routine patient care—the primary focus of your career?

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The Nuclear Imaging Institute (NII) seeks a highly organized, research-focused Clinical Trials & Regulatory Manager to lead the operational and regulatory execution of our expanding clinical research portfolio.

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At NII, you will participate across the clinical trial continuum—from early concept and protocol development through study execution and regulatory maintenance. Working directly with the Executive Director/Principal Investigator and the Director of Operations, you will help shape processes in a lean, collaborative environment where your contributions have visible impact.

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This opportunity is designed for a clinician who is enthusiastic about leading research programs and building regulatory and operational systems, while maintaining a meaningful clinical role. NP or PA credentials are required to support focused clinical assessments, CT contrast administration and oversight, and management of medical events during imaging and research visits.

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About Us

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The Nuclear Imaging Institute is advancing molecular imaging and radiopharmaceutical innovation through multiple clinical trials, including studies of advanced ultralow-dose positron emission tomography (PET), Magnetic Resonance Imaging (MRI) and other modalities. Our goal is to support earlier disease detection, increase health span, and facilitate healthy aging.

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Our work spans molecular imaging, neuroscience, and oncology. We offer an environment where research professionals can take ownership, influence strategy, and help build the infrastructure supporting innovative clinical studies.

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About the Role

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A research-focused leadership position for a Nurse Practitioner or Physician Assistant, with approximately 90% of responsibilities in clinical trials and regulatory affairs and 10% in clinical support, leading the operational and regulatory execution of an expanding clinical research portfolio while providing focused clinical support for imaging and research activities.

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Responsibilities

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Research Operations & Regulatory Affairs

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• Clinical Trial Leadership and Execution
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• Guide protocol and informed consent development, integrating scientific objectives, participant safety, operational feasibility, and applicable FDA and ICH Good Clinical Practice standards.
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• Oversee trial start-up activities, including site regulatory packages, FDA Forms 1572 where applicable, investigator CVs, financial disclosures, delegation records, and coordination of radiation dosimetry documentation and required approvals.
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• Manage study implementation and ongoing operations, including screening and enrollment workflows, visit coordination, protocol adherence, participant follow-up, study documentation, and research milestones.
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• Coordinate ClinicalTrials.gov registrations, updates, and results reporting, as applicable, and support the PI in oversight of vendors and contract research organizations.
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Compliance and Quality Management

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• Develop and maintain standard operating procedures, policies, and regulatory templates to ensure consistent, compliant research practices.
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• Oversee essential regulatory documents and maintain complete, accurate, and inspection-ready electronic trial master files and investigator site files, as applicable.
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• Coordinate adverse-event and serious-adverse-event documentation, follow-up, and required reporting to sponsors, IRBs, and the FDA in collaboration with the PI.
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• Prepare for and support FDA, sponsor, and institutional audits and inspections; oversee protocol-deviation tracking, corrective and preventive actions, and continuous quality improvement.
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Regulatory Strategy and Submissions

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• Lead the preparation, submission, and maintenance of FDA Investigational New Drug applications (INDs), including exploratory IND studies, Investigational Device Exemptions (IDEs) where applicable, and associated amendments and regulatory responses.
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• Prepare and manage annual reports, safety reports, and Development Safety Update Reports (DSURs), as applicable.
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• Serve as a key point of contact for the FDA, institutional review boards, data and safety monitoring boards, sponsors, and research collaborators.
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• Draft, review, and coordinate finalization of briefing documents, meeting requests, and agency correspondence in partnership with the PI and relevant technical experts.
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Research Team Leadership and Collaboration

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• Partner closely with the PI, clinical research coordinators, imaging technologists, radiopharmacy, radiation safety, and data teams to support efficient study execution.
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• Train staff and investigators on regulatory processes, GCP compliance, study documentation, and participant-safety procedures.
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• Manage external consultants and research partners, coordinate deliverables, and identify practical improvements to research workflows and infrastructure.
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Clinical Provider Support

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• The clinical component supports NII’s imaging and research activities and is secondary to the position’s research and regulatory responsibilities.
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• Perform focused clinical assessments related to study eligibility, imaging readiness, contrast safety, and medical concerns arising during research or imaging visits.
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• Administer intravenous CT or MRI contrast and provide clinical oversight of contrast-related care, including supervision of administration where legally permitted, within the provider’s authorized scope of practice, NII protocols, and required physician-coverage arrangements.
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• Assess and initiate management of contrast reactions and other medical events, provide initial stabilization and appropriate treatment, and coordinate physician assistance, emergency medical services, or transfer when indicated.
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• Document clinical care and coordinate appropriate follow-up, serving as a sub-investigator when designated and helping maintain contrast-safety procedures, emergency readiness, and staff training.
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• The anticipated allocation reflects overall workload; clinical needs may vary with the study schedule. During assigned clinical coverage, participant safety and timely response to medical concerns take priority.
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Qualifications

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Required

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• Nurse Practitioner or Physician Assistant credentials , with graduation from an accredited NP or PA program, current unrestricted New Jersey licensure/certification as applicable, and current national certification appropriate to the role.
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• Clinical competence in patient assessment, medication administration, recognition of acute medical problems, and initial management of medical events.
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• Current Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) certification; documented contrast-safety and contrast-reaction-management competency before assuming related clinical responsibilities.
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• Ability to obtain and maintain the clinical privileges, prescribing authority, and physician collaboration or supervision arrangements required for assigned duties.
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• Exceptional organizational, communication, and writing skills, with the judgment and initiative needed to work effectively in a small, collaborative research organization.
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• Prior experience with contrast-enhanced imaging, infusion care, emergency medicine, or acute care is valuable for the clinical-support component.
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Preferred

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• Substantial hands-on experience in clinical research operations and regulatory affairs , including preparation or maintenance of FDA IND submissions and participation in FDA and IRB interactions.
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• Demonstrated ability to manage multiple clinical studies, regulatory deadlines, essential documents, and cross functional research activities.
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• Strong knowledge of ICH GCP, applicable FDA regulations, human-subject protections, clinical trial design, safety reporting, and regulatory strategy.
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• Experience in molecular imaging, radiopharmaceuticals, oncology, early-phase studies, or investigator-initiated research is preferred. Familiarity with electronic data capture systems and electronic regulatory-document platforms is desirable.
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• Relevant research or regulatory certification, such as ACRP, SOCRA, or RAC
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Why Join NII?

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Make research your primary focus. Dedicate the great majority of your work to advancing clinical studies, developing regulatory strategy, and building effective research programs.

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Advance innovative science. Play a pivotal role in first-in-human and exploratory studies using next-generation molecular imaging and radiopharmaceutical technologies.

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Have ownership and impact. Work directly with the Executive Director/Principal Investigator and Director of Operations, influence decisions, and develop processes that support a growing research institute.

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Maintain a meaningful clinical connection. Apply your NP or PA expertise in a focused supporting role that contributes directly to participant safety without making routine clinical care the center of your position.