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.
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.
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.
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.
NewHealthcare Regulatory Associate Attorney JobotHealthcare Regulatory Associate AttorneyNew York, NY$260,000–$360,000 / yearBillable-hour framework: 2,000-hour annual bonus threshold, with market reporting indicating approximately 1,800 client-billable hours and up to 200 qualifying hours for pro bono and other approved activities. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal.
Associate Director, Epidemiology Analytics Daiichi Sankyo, Inc.Associate Director, Epidemiology AnalyticsBasking Ridge, NJ$157,920–$236,880 / yearFull timeProvide data management of diverse data (e.g., real-world setting and clinical trial) to set up epidemiologic data sets for various approaches, quantitative epidemiologic data analysis, interpretation of results, visualization of results, and generate manuscripts to disseminate findings. Doctorate Degree (PhD) in Biostatistics, Data Science, Statistics, Applied Mathematics, Epidemiology or related field plus a minimum of 4 years of experience in epidemiologic methods and data analysis (pharmaceutical industry in safety or associated service provider experience is preferred).
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.
NewAssociate Director, Biostatistics Daiichi Sankyo, Inc.Associate Director, BiostatisticsBasking Ridge, NJ$175,440–$263,160 / yearFull timeProtocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.
Associate Director, Companion Diagnostics Leader Daiichi Sankyo, Inc.Associate Director, Companion Diagnostics LeaderBasking Ridge, NJ$166,720–$250,080 / yearFull timeContributes to CDx project teams for the diagnostic, under the direction of the Global Program Teams (GPT) CDx representative for the therapeutic or under the guidance of the CDx portfolio leader, covering all areas from CDx assay development through CDx approval and launch. Provides scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liaisons to ensure successful implementation of CDx and data collection.
NewTravel Nurse RN - SICU - Surgical Intensive Care - $2,572 per week Prime StaffingTravel Nurse RN - SICU - Surgical Intensive Care - $2,572 per weekNew York City, NYSkills:NYS RN License, BLS, 2 years of Post Open Heart and Cardiac Care Unit experience, Min 2 years RN experience, 1 year travel experience for Travel positions, not required for Per Diem positions, EPIC experience highly preferred Required Skills: [ "CARDIO Surgical ICU"]Education: Bachelor of Science with a major in nursing preferred. Role models the tenets of Mount Sinai Relationship Centered Care (MSHRCC) through facilitation of the following actions including, but not limited to, Admission Welcome, Bedside shift Report, HELP (High Risk Medications, Equipment, Lines/Drains/Airway, Pain and Plan of Care) AM/PM Care, 5 Minute Sit Down, Purposeful Hourly Rounding, Medication Review, Discharge Wrap Up, and MD/RN Unit Collaboration.2.
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.
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 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.
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 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 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.