Executive Director, US Medical Research & Strategy, Operations, and Engagement Daiichi Sankyo, Inc.Executive Director, US Medical Research & Strategy, Operations, and EngagementBasking Ridge, NJ$271,500–$452,500 / yearFull timeAdditionally, the Executive Director contributes to excellence in clinical research by developing strategies for lifecycle management, IIS programs and post approval clinical programs in consultation with commercial, development and outside experts, and by building the image of the company as a partner in research projects. Oversee a Medical Affairs oncology team that works alongside Oncology Field Medical Affairs for interactions with Key External Experts in Oncology including advisory boards, Congress activities, and investigator initiated studies, advocacy and sponsorships.
Associate Director, Clinical Science Daiichi Sankyo, Inc.Associate Director, Clinical ScienceBasking Ridge, NJ$162,400–$243,600 / yearFull timeUnder supervision of Clinical Science Asset Lead or Clinical Science Lead within Hematology, drafts development plans, protocol profiles, protocols, informed consent forms, and sections of submission documents. Advanced Technical Expertise: Possess advanced understanding of pre-clinical and clinical research, including protocol writing, data review, study design, and disease area knowledge preferred.
Director, Clinical Science Daiichi Sankyo, Inc.Director, Clinical ScienceBasking Ridge, NJ$201,840–$302,760 / yearFull timeProgram related: Integrated Study Team (IST) representative: Creates early development plan and contributes to overall development strategy; Contributes to development of program biomarker strategy; Achieves endorsement for plan by function and team; Interprets and react accordingly to new preclinical/clinical data(e.g. Participates in creation of developmental and regulatory strategies and prepares clinical sections of regulatory documents; acts as the Point of Contact for interactions with regulatory agencies related to clinical matters.
Head, Global Oncology Medical Affairs, Clinical Trial Management, Resources, Operations & Governance Daiichi Sankyo, Inc.Head, Global Oncology Medical Affairs, Clinical Trial Management, Resources, Operations & GovernanceBasking Ridge, NJ$271,500–$452,500 / yearFull timeEnsure all key internal stakeholders are aligned on the approach and the conduct of a global studies/programs that will be implemented in multi-regions (US, Europe, ASCA, Japan)- including Regional Medical, Regional Operations, Safety, Regulatory, Quality, Legal/Compliance, Clinical Supply Operations, Global Program Teams, GMAT Leads, GMA leadership. Responsible for primary data evidence generation delivery of GMA programs: Company Initiated studies (CIS), Non-Interventional Studies (NIS) and Expanded Access Programs (EAP) delivery across countries in Oncology Business Unit and other Regions.
Senior Director, Clinical Development Daiichi Sankyo, Inc.Senior Director, Clinical DevelopmentBasking Ridge, NJ$280,350–$467,250 / yearFull timeMay contribute to addressing questions about medical decisions, clinical data review, protocol deviations, etc., and/or scientific aspects of the study during FDA, MHRA, EMA, and PMDA interactions, such as pre-submissions, end of phase 1/2, and inspections. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
Senior Director, Clinical Development - Hematology Daiichi Sankyo, Inc.Senior Director, Clinical Development - HematologyBasking Ridge, NJ$280,350–$467,250 / yearFull timeMay contribute to addressing questions about medical decisions, clinical data review, protocol deviations, etc., and/or scientific aspects of the study during FDA, MHRA, EMA, and PMDA interactions, such as pre-submissions, end of phase 1/2, and inspections. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
NewRN Preceptor VNS HealthRN PreceptorNew York, NY$126,413–$160,188 / yearMinimum of one year of experience as a field staff nurse in VNS Health Home Care, which includes ability to manage/document cases with a minimum of supervision, identify/assess/formulate/implement action plan to address problem and evaluate outcome preferred and. We’re one of the largest nonprofit home- and community-based health care organizations in the country, and today, more than 11,500 team members work together to make a difference in the lives of more than 99,000 patients and members on any given day.
Clinical Research Coordinator, Research Biofluid Management Unit; Monday-Friday, 11AM - 7PM * Oncology clinical research experience preferred * NYU Langone HealthClinical Research Coordinator, Research Biofluid Management Unit; Monday-Friday, 11AM - 7PM * Oncology clinical research experience preferred *New York, NY$70,481.60–$76,450Full timeIntermediate competency in medical terminology, and an advanced competency in Good Clinical Practice (GCP) guidelines, Federal Regulation that govern the conduct of human subjects research as well as Institutional Review Board and institutional policies and procedures related to human subjects research. Record, update, edit, and maintain confidential information relating to research biospecimens onto paperwork and/or web-based forms in a neat, accurate and timely manner and ensure subsequent data collection as required.
Clinical Research Coordinator, Research Biofluid Management Unit; Monday-Friday, 11AM - 7PM * Oncology clinical research experience preferred * New York University School of MedicineClinical Research Coordinator, Research Biofluid Management Unit; Monday-Friday, 11AM - 7PM * Oncology clinical research experience preferred *New York, NY$70,481.60–$76,450 / yearIntermediate competency in medical terminology, and an advanced competency in Good Clinical Practice (GCP) guidelines, Federal Regulation that govern the conduct of human subjects research as well as Institutional Review Board and institutional policies and procedures related to human subjects research. Record, update, edit, and maintain confidential information relating to research biospecimens onto paperwork and/or web-based forms in a neat, accurate and timely manner and ensure subsequent data collection as required.
Clinical Research Associate I - Center for Interventional Cardiovascular Research and Clinical Trials Mount Sinai Health SystemClinical Research Associate I - Center for Interventional Cardiovascular Research and Clinical TrialsNew York, NY$58,661–$81,675 / yearMount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology.
NewClinical Research Associate - Sponsor Dedicated IQVIAClinical Research Associate - Sponsor DedicatedParsippany, KansasIn this role, you will be responsible for overseeing clinical trial sites to ensure studies are conducted in compliance with study protocols, regulatory requirements, Good Clinical Practice (GCP), International Council for Harmonization (ICH) guidelines, and sponsor expectations. Successful candidates will possess strong site management skills, a commitment to quality, and the ability to build productive relationships with investigators and site personnel.
NewSenior Clinical Data Coordinator - Clinical Research Hackensack Meridian HealthSenior Clinical Data Coordinator - Clinical ResearchParamus, New JerseyFull timeOrganizes and prepares for all study related sponsor visits up including, but not limited to Pre-Site Initiation Visits, Site Initiation Visits, Routine Monitor Visits, Close-Out Visits, Internal Audits, and Sponsor Audits. Works daily in collaboration with other research team members including but not limited to Principal Investigators, Research Nurse Coordinators, Clinical Research Coordinators, Sponsors, Contract Research Organizations, and employees of Hackensack Meridian Health.
Senior Clinical Research Associate Zp Group LlcSenior Clinical Research AssociateNYRemote$155,000–$175,000 / yearKeywords: clinical research, clinical trials, CRA, oncology, general medicine, GCP, ICH, regulatory compliance, site monitoring, CTMS, EDC, patient recruitment, protocol training, clinical documentation, data review, query resolution, clinical operations, FDA regulations, SOPs, quality oversight, risk-based monitoring, therapeutic areas. Responsibilities of the Senior Clinical Research Associate include: Independently manage site monitoring activities for Phase II and III oncology trials, including a combination of onsite and remote visits averaging 8-10 onsite days per month.
Senior Clinical Research Associate (Field- Based) - Multiple Openings NAMSA IncSenior Clinical Research Associate (Field- Based) - Multiple OpeningsNY$68,800–$133,700 / yearAssess the suitability of potential investigative sites through screening interviews, regulatory document review and evaluation of study information and provides input to the site selection process. Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc.
Senior Clinical Research Associate Protagonist TherapeuticsSenior Clinical Research AssociateNewark, New JerseySupport study vendor management by performing key activities as delegated by study CTM, including but not limited to: Participate in evaluation of new vendors (CROs, labs, central readers, EDC, etc.) by drafting and/or reviewing RFPs, analyzing responses and drafting work orders for select vendors • Manage the day to day interactions with select study vendor(s), such as a central or specialty lab including developing training materials, lab manuals and acting as first point of contact for issue and query escalation and resolution. Yes, up to 10% Core Responsibilities Overall Study Execution Part of the clinical study team and takes a lead on execution by performing key activities as delegated by the Clinical Study lead, including but not limited to: Develop and/or review key study operational documents (e.g., study reference manual, laboratory and pharmacy manuals, data management plan, query generation, monitoring plan; review site audit reports) •.
On-site Clinical Research Associate Protagonist TherapeuticsOn-site Clinical Research AssociateNewark, New JerseyThe Company also has a number of clinical and preclinical programs based on clinically and commercially validated targets and addressing unmet medical needs, including an oral IL-17 antagonist peptide, anti-obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin discovery programs. Clinical Research Associate About Us Protagonist Therapeutics is a biopharmaceutical company built on a proprietary peptide technology platform that has now produced two FDA-approved, first-in-class medicines, generating royalties and milestones from global commercial partnerships with Johnson and Johnson and Takeda Pharmaceutical Company Limited.
Clinical Research Associate - Sponsor Dedicated IQVIA Holdings IncClinical Research Associate - Sponsor DedicatedParsippany, NJ$71,900–$189,000 / yearIn this role, you will be responsible for overseeing clinical trial sites to ensure studies are conducted in compliance with study protocols, regulatory requirements, Good Clinical Practice (GCP), International Council for Harmonization (ICH) guidelines, and sponsor expectations. Successful candidates will possess strong site management skills, a commitment to quality, and the ability to build productive relationships with investigators and site personnel.
Clinical Research Associate II (Field CRA) Penumbra IncClinical Research Associate II (Field CRA)NY$89,000–$130,000 / yearMinimum education and experience: Bachelor's degree required in biological sciences or health-related field (e.g., biology, chemistry, biochemistry, nursing, biomedical or veterinary sciences) with 3+ years of experience in clinical/scientific research, nursing, or medical devices/ pharmaceutical industry required, and 1+ years of clinical monitoring experience, or an equivalent combination of education and experience. Assist clinical team with the development, approval, and distribution of study-related documents including Case Report Forms (CRF's), study protocols, study manuals, and other study tools to investigational sites and review committees.
Senior Clinical Research Associate - CNS/Psychiatry - Northeast Worldwide Clinical Trials Holdings IncSenior Clinical Research Associate - CNS/Psychiatry - NortheastNJ$97,000–$193,000 / yearTypically involved in all stages of the clinical study, including identifying potential sites to participate in the research effort, performing various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets, training the sites to collect data properly and report any potential safety-related events, managing the site's activities during study maintenance, and closing down research activities at the sites once the study has concluded. As a Clinical Research Associate (CRA) at Worldwide, you will find yourself working alongside brilliant minds across diverse therapeutic areas, including Cardiovascular, Metabolic, Neuroscience, Oncology, and Rare Diseases.
Clinical Research Associate II/III Novotech Health Holdings Pte LtdClinical Research Associate II/IIINY$70,000–$140,000 / yearPreferably experience of working in the research, pharmaceutical industry or a related field per job level as follows: CRA II: Approximately 1-2 years of Clinical Research Associate experience or equivalent experience (CRA II fast track) in other roles in the Clinical industry. Provide written and verbal site updates (including monitoring visit reports) on study progress to the PM/LCRA according to the study requirements/timelines as documented in the Clinical Monitoring Plan and Sponsor/Novotech SOPs.