Research Associate 5PY IQVIA RDS Inc.Research AssociateLake Hiawatha, NJ$47,400–$169,300 / yearEnsure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements. • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Sr Clinical Study Assoc CO Daiichi Sankyo, Inc.Sr Clinical Study Assoc COBasking Ridge, NJ$100,960–$151,440 / yearFull timeKey focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP). 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.
NewExecutive 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, drafts development plans, protocol profiles, protocols, informed consent forms, and sections of submission documents. Provides strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan and to Clinical Operations on SDV plan.
NewAssociate Director, Clinical Development Trial Lead (CDTL) JouléAssociate Director, Clinical Development Trial Lead (CDTL)Stamford, CT$104.63 / hourThis highly visible leadership role offers the opportunity to oversee study strategy, enrollment, budgets, CRO partnerships, and cross-functional teams while influencing clinical development decisions on a global scale. Joulé is partnering with a leading pharmaceutical organization seeking an experienced Associate Director, Clinical Development Trial Lead to drive the execution of complex global oncology clinical trials.
NewExecutive Director, Global Oncology Medical Affairs, Clinical Trial Management, Resources, Operation Daiichi Sankyo, Inc.Executive Director, Global Oncology Medical Affairs, Clinical Trial Management, Resources, OperationBasking 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.
NewExecutive Medical Director, Clinical Development - M.D. (Nephrology) Clinical Dynamix, Inc.Executive Medical Director, Clinical Development - M.D. (Nephrology)Jersey City, NJThe Clinical Development Executive Medical Director is the clinical leader of the specific clinical programs assigned with responsibility for outlining the overall clinical development strategy in line with regulatory requirements and sound scientific rationale, designing the clinical protocols, guiding the Clinical Operations team towards the adequate implementation of such protocols, ensuring adequate medical monitoring activities are implemented for the conduction of clinical studies and analyzing the data from the clinical program. The individual will also be responsible for ensuring adequate implementation of the global safety surveillance and pharmacovigilance for the investigational products, including review and analysis of safety data from clinical trials and other permitted sources (e.g., early access/expanded access programs, if applicable), identification and investigation of safety signals, and management of the benefit-risk profile for assigned compounds.
Senior Director, Biostatistics CellectisSenior Director, BiostatisticsNew York, NY$220,000–$240,000 / yearIn collaboration with functional leads, ensure that the execution of clinical trials, (specifically data capture, cleaning) delivers quality and timely ongoing and final databases, develop strategies to minimize the cost of clinical trial execution in delivering quality clinical trial data and ensure that clinical trial systems used in the running of clinical trials are effectively linked to avoid conflicting information. Minimum 15 years of experience in leading biostatistics in clinical research (at various levels and in different capacities), including having built the biostatistics function and 5 years managing a biostatistical group working on all phases of clinical research and drug development.
Clinical Research Associate (CRA) - Cardiovascular/Vaccine/Infectious Disease- Remote Merck & Co IncClinical Research Associate (CRA) - Cardiovascular/Vaccine/Infectious Disease- RemoteNew York, NYRemote$96,200–$151,400 / yearRequired Skills: Adverse Event Reporting System, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Core Competencies, Data Analysis, Data Reporting, Early Clinical Development, Policy Development, Preventive Action, Protocol Adherence, Regulatory Compliance, Site Management. Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
Clinical Research Associate (CRA) - Immunology-Remote Merck & Co IncClinical Research Associate (CRA) - Immunology-RemoteRahway, NJRemote$96,200–$151,400 / yearRequired Skills: Adverse Event Reporting System, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Core Competencies, Early Clinical Development, Policy Development, Preventive Action, Protocol Adherence, Regulatory Affairs Compliance, Regulatory Compliance, Site Management, Training Team Members. Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
Clinical Research Associate (CRA) Zp Group LlcClinical Research Associate (CRA)NYRemote$155,000–$175,000 / yearThe Clinical Research Associate (CRA) role is ideal for an experienced monitor with a strong background in oncology studies, site management, and ensuring regulatory and protocol compliance across multi-site trials. Piper Companies is seeking a Clinical Research Associate (CRA) to support oncology-focused clinical trials for a leading organization within the life sciences and pharmaceutical research industry.
Research Billing Specialist Hackensack Meridian HealthResearch Billing SpecialistHackensack, New JerseyQualifications: Education, Knowledge, Skills and Abilities Required : Bachelor`s Degree in Accounting, Sciences or equivalent experience and High School diploma, general equivalency diploma (GED), GED equivalent programs, and/or other Vocational degrees/certificates. The posted rate of pay in this job posting is a reasonable good faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package.
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.
Sr Clinical Research Associate (Sr CRA) - Ophthalmology-Remote Merck & Co IncSr Clinical Research Associate (Sr CRA) - Ophthalmology-RemoteRahway, NJRemote$129,000–$203,100 / yearRequired Skills: Adverse Event Report, Clinical Data Management, Clinical Development, Clinical Research, Clinical Research Organizations (CRO) Management, Clinical Study Management, Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trials Monitoring, Early Clinical Development, Preventive Action, Regulatory Affairs Compliance, Site Management. Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
Clinical Research Associate (CRA) - Cardiovascular (Remote) Merck & Co IncClinical Research Associate (CRA) - Cardiovascular (Remote)Rahway, NJ$96,200–$151,400 / yearConducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
Clinical Research Associate (CRA) - Oncology (Remote) Merck & Co IncClinical Research Associate (CRA) - Oncology (Remote)Rahway, NJRemote$96,200–$151,400 / yearConducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
Clinical Research Coordinator, Research Biofluid Management Unit; Monday-Friday, 11AM - 7PM * Oncology clinical research experience preferred * NYU Langone Medical CenterClinical 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.
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.
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.
Senior Clinical Research Associate I Zp Group LlcSenior Clinical Research Associate INYRemote$115,000–$125,000 / yearKeywords: clinical research, clinical trials, CRA, GCP, ICH, regulatory compliance, site monitoring, clinical monitoring, CTMS, EDC, cardiovascular studies, CNS trials, diabetes research, GLP-1, site management, FDA regulations, clinical operations, documentation, quality assurance, protocol compliance, investigator sites, patient safety, clinical development. Piper Companies is seeking a Senior Clinical Research Associate I to join a global organization within the clinical research and life sciences industry for a remote permanent role with 60-75% travel to sites in the US.