Clinical Trials & Regulatory Manager (NP/PA)
hace 10 horas
Englewood
Reports to: Executive Director / Director of Operations A Research Leadership Opportunity for an NP or PA 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? 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. 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. 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. About Us 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. 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. About the Role 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. Responsibilities Research Operations & Regulatory Affairs • Clinical Trial Leadership and Execution, • Guide protocol and informed consent development, integrating scientific objectives, participant safety, operational feasibility, and applicable FDA and ICH Good Clinical Practice standards., • 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., • Manage study implementation and ongoing operations, including screening and enrollment workflows, visit coordination, protocol adherence, participant follow-up, study documentation, and research milestones., • Coordinate ClinicalTrials.gov registrations, updates, and results reporting, as applicable, and support the PI in oversight of vendors and contract research organizations. Compliance and Quality Management • Develop and maintain standard operating procedures, policies, and regulatory templates to ensure consistent, compliant research practices., • Oversee essential regulatory documents and maintain complete, accurate, and inspection-ready electronic trial master files and investigator site files, as applicable., • Coordinate adverse-event and serious-adverse-event documentation, follow-up, and required reporting to sponsors, IRBs, and the FDA in collaboration with the PI., • Prepare for and support FDA, sponsor, and institutional audits and inspections; oversee protocol-deviation tracking, corrective and preventive actions, and continuous quality improvement. Regulatory Strategy and Submissions • 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., • Prepare and manage annual reports, safety reports, and Development Safety Update Reports (DSURs), as applicable., • Serve as a key point of contact for the FDA, institutional review boards, data and safety monitoring boards, sponsors, and research collaborators., • Draft, review, and coordinate finalization of briefing documents, meeting requests, and agency correspondence in partnership with the PI and relevant technical experts. Research Team Leadership and Collaboration • Partner closely with the PI, clinical research coordinators, imaging technologists, radiopharmacy, radiation safety, and data teams to support efficient study execution., • Train staff and investigators on regulatory processes, GCP compliance, study documentation, and participant-safety procedures., • Manage external consultants and research partners, coordinate deliverables, and identify practical improvements to research workflows and infrastructure. Clinical Provider Support • The clinical component supports NII’s imaging and research activities and is secondary to the position’s research and regulatory responsibilities., • Perform focused clinical assessments related to study eligibility, imaging readiness, contrast safety, and medical concerns arising during research or imaging visits., • 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., • 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., • 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., • 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. Qualifications Required • 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., • Clinical competence in patient assessment, medication administration, recognition of acute medical problems, and initial management of medical events., • 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., • Ability to obtain and maintain the clinical privileges, prescribing authority, and physician collaboration or supervision arrangements required for assigned duties., • Exceptional organizational, communication, and writing skills, with the judgment and initiative needed to work effectively in a small, collaborative research organization., • Prior experience with contrast-enhanced imaging, infusion care, emergency medicine, or acute care is valuable for the clinical-support component. Preferred • 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., • Demonstrated ability to manage multiple clinical studies, regulatory deadlines, essential documents, and cross functional research activities., • Strong knowledge of ICH GCP, applicable FDA regulations, human-subject protections, clinical trial design, safety reporting, and regulatory strategy., • 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., • Relevant research or regulatory certification, such as ACRP, SOCRA, or RAC Why Join NII? Make research your primary focus. Dedicate the great majority of your work to advancing clinical studies, developing regulatory strategy, and building effective research programs. Advance innovative science. Play a pivotal role in first-in-human and exploratory studies using next-generation molecular imaging and radiopharmaceutical technologies. 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. 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.
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