NewClinical Research Associate, Full Service 5PY IQVIA RDS Inc.Clinical Research Associate, Full ServiceParsippany, 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.
NewResearch Associate – Oncology 5PY IQVIA RDS Inc.Research Associate – OncologyMountain Lakes, 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.
NewResearch Associate 5PY IQVIA RDS Inc.Research AssociateWhippany, 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.
NewClinical Monitoring Associate 5PY IQVIA RDS Inc.Clinical Monitoring AssociateBoonton, 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.
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.
NewStudy Delivery Lead, Clinical Operations Daiichi Sankyo, Inc.Study Delivery Lead, Clinical OperationsBasking Ridge, NJ$171,120–$256,680 / yearFull timeThe SDL fosters an environment where the core study team maximizes their expertise and contribution to trial delivery, including but not limited to issue resolution, risk mitigation and escalation to Global Project Team (GPT), SCORE and other governance level as needed The SDL will have regular interactions with key internal and external stakeholders to discuss project status, escalate issues, and troubleshoot inquiries. The Study Delivery Lead (SDL) leads the cross functional core and extended clinical study team in end-to end delivery of the clinical trial with consistency, quality and per planned timelines.
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.
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 FDA Attorney JobotSenior FDA AttorneyPine Brook, NJRemote$250,000–$400,000 / yearThis is a senior-level opportunity for an attorney with at least 10 years of substantive FDA experience who is prepared to advise clients on sophisticated regulatory, compliance, transactional, and enforcement matters involving pharmaceuticals, compounding pharmacies, drug and device manufacturers, clinical trials, dietary supplements, veterinary products, and other FDA-regulated businesses. The firm is focused exclusively on healthcare and life sciences and represents clients across the full healthcare ecosystem, including pharmacies, physician groups, hospitals, ambulatory surgery centers, laboratories, manufacturers, suppliers, ancillary service providers, and emerging healthcare businesses.
Social Work - School Licensed Clinical Social Worker - $2,444 per week Amergis Healthcare Staffing, Inc.-AlliedSocial Work - School Licensed Clinical Social Worker - $2,444 per weekNewark, NJAs part of a student-focused care and support program, you'll collaborate with campus partners to help students navigate mental health concerns, personal challenges, and crisis situations while promoting overall well-being and academic success. This campus is known for its strong commitment to student success, community engagement, and inclusive excellence, creating a dynamic environment where clinicians can make a meaningful impact on the lives of young adults during a pivotal stage of development.
Clinical Research Associate (CRA) Manager Novartis AGClinical Research Associate (CRA) ManagerEast Hanover, NJRemote$145,600–$270,400 / yearJob Title: Clinical Research Associate (CRA) Manager #LI-Remote Location: Continental United States (field-based; candidates should be located near a major airport) Relocation Support: This position can be based remotely anywhere in the Continental U.S. (there may be some restrictions based on legal entity). As the CRAM, you will play a vital role in developing and empowering a high-performing team of Clinical Research Associates who drive the successful execution of clinical studies across the United States.
Clinical Research Associate (CRA) Manager - Remote Merck & Co IncClinical Research Associate (CRA) Manager - RemoteRahway, NJRemote$142,400–$224,100 / yearRequired Skills: Clinical Research Methods, Clinical Study Management, Clinical Trials, Clinical Trials Monitoring, Data Reporting, ICH GCP Guidelines, Multiple Therapeutic Areas, People Leadership, People Management, Performance Monitoring, Project Management, Resource Planning, Site Management, Stakeholder Management, Study Monitoring, Team Management. Under the oversight of the CRD or Head of Site Management and Monitoring, the person is responsible to manage a team of 6-14 CRAs and to ensure excellent study and site performance with strict adherence to local regulations, company SOPs and ICH GCP.
Clinical Research Associate (CRA) - Cardiovascular (Remote) Merck & Co IncClinical Research Associate (CRA) - Cardiovascular (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 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.
Lead Clinical Research Associate Integrated Resources, IncLead Clinical Research AssociateRaritan, New JerseyFull timeThe LCRA acts as a primary liaison between Field Based CRAs and the Clinical Project Lead (CPL).Additional responsibilities include:• Implementation of enrollment and recruitment strategies• Assistance in vendors' selection processes• Development, execution, management and compliance assurance of the Monitoring Plan• Review and approve trip reports, track scheduling, report submission metrics, site deviations and action items• Oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.• Job DescriptionTitle: Lead Clinical Research AssociateLocation: Raritan, NJ 08869Responsibilities:Lead Clinical Research Associate:Under supervision of Clinical Project Lead, oversees performance of assigned field monitors and site activities in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and federal regulations.
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) •.
Clinical Research Associate Integrated Resources, IncClinical Research AssociateSouth Plainfield, New JerseyFull timeJOB RESPONSIBILITIES:Support project management oversight of Clinical Development activities for multiple domestic and international trials, including:Track study timelines;Review and track study budgets;Provide periodic updates on Clinical DevelopmentGradually develop responsibilities for management of contract research organization (CROs) activities for clinical and data managementProvide monitoring support, in some cases functioning as the primary site monitor. Job DescriptionThe Clinical Research Associate for Clinical Operation will provide site monitoring and management oversight across multiple clinical research trials in support of development of Pharmaceutical's drug pipeline.
NewOn-site Clinical Research Associate Protagonist TherapeuticsOn-site Clinical Research AssociateNewark, New JerseyThe Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets including an oral IL-17 peptide antagonist, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs. Yes, up to 10% Core Responsibilities Serves as the internal primary site operations lead, working with the Project Manager and CROs to achieve efficient study set-up and initiation, ongoing data monitoring all the way through successful study execution and site close-out.
Sr. Clinical Research Associate Systimmune IncSr. Clinical Research AssociatePrinceton, NJ$90,000–$130,000 / yearPrepare the study reference manual, including liaising with the Contract Research Organization (CRO) team (i.e., central lab, specialty labs and vendors) to ensure efficient preparation and delivery of study materials to investigator sites. CRA is responsible for the management and oversight of their assigned clinical study sites to ensure data quality and patient safety in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs.
FSP Sr. Clinical Research Associate II - NYC Metro or PHL - Onc Fortrea IncFSP Sr. Clinical Research Associate II - NYC Metro or PHL - OncTrenton, NJ$125,000–$140,000 / yearResponsibilities: Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned -. Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible data.