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.
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.
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 Associate - Fixed Term Stanford UniversityClinical Research Coordinator Associate - Fixed TermNY$30.35–$48.51 / hourStanford University is seeking a Clinical Research Coordinator Associate to perform duties related to the coordination of a large multisite clinical study, assessing the efficacy of telehealth video therapy platforms on engagement in youth with anxiety and mood conditions. Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
FSP Sr. Clinical Research Associate II - NYC Metro or PHL - Onc Fortrea IncFSP Sr. Clinical Research Associate II - NYC Metro or PHL - OncNew York, NYRemote$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.
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 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.
Senior Clinical Research Associate BeOne Medicines AGSenior Clinical Research AssociateNY$105,800–$140,800 / yearThe SCRA collaborates with the Clinical Study Teams (CSTs) by supporting day to day clinical study activities, departmental tasks, and provides mentoring to other CRA team members within established protocols and portfolio under general supervision. General Description: The SCRA is primarily a site monitor and 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.
Associate Clinical Research Coordinator New York University School of MedicineAssociate Clinical Research CoordinatorNew York, NYPrepares for upcoming study visits: research bio-specimen collection order preparation/placement, laboratory and EKG order placement, scheduling of biopsies and scans, interpreter requests, facilitating tumor assessment form completion from the investigator, QOL, AE and ConMed form completion in conjunction with a licensed professional (CRN/APP/MD) and other tasks as needed to support seamless, safe, and compliant clinical research conduct per protocol. Schedules study participants according to the approved protocol; coordinates with ancillary service providers to ensure patients remain adherent to the protocol; coordinates subjects tests and procedures in compliance with the particular protocol and with the appropriate department, and collaborates with other NYU and PCC departments to seamlessly navigate a patient to a trial and through screening, treatment and follow up/end of treatment.
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.
Associate Clinical Research Coordinator NYU Langone Medical CenterAssociate Clinical Research CoordinatorNew York, NYPrepares for upcoming study visits: research bio-specimen collection order preparation/placement, laboratory and EKG order placement, scheduling of biopsies and scans, interpreter requests, facilitating tumor assessment form completion from the investigator, QOL, AE and ConMed form completion in conjunction with a licensed professional (CRN/APP/MD) and other tasks as needed to support seamless, safe, and compliant clinical research conduct per protocol. Schedules study participants according to the approved protocol; coordinates with ancillary service providers to ensure patients remain adherent to the protocol; coordinates subjects tests and procedures in compliance with the particular protocol and with the appropriate department, and collaborates with other NYU and PCC departments to seamlessly navigate a patient to a trial and through screening, treatment and follow up/end of treatment.
Senior Clinical Research Associate (Remote - Field Based) Novartis AGSenior Clinical Research Associate (Remote - Field Based)NYRemote$108,500–$201,500 / yearKey ResponsibilitiesLead assigned sites as the primary point of contact throughout study deliveryBuild strong relationships to ensure site performance, quality, and milestone achievementManage Phase I to Phase IV trials per monitoring plans and company proceduresConduct site initiation visits and deliver ongoing training for site personnelPerform remote and on-site monitoring to ensure compliance and patient safetyMaintain accurate documentation and update all clinical systems in a timely mannerIdentify risks, resolve issues, and escalate concerns as neededCollaborate with cross-functional teams to drive efficient study executionSupport timely data query resolution and ensure data accuracyAct as a subject matter expert across study activities when requiredEssential RequirementsMinimum of three years of clinical site monitoring experienceMinimum of Bachelor's degree in science, healthcare, or a related fieldStrong understanding of clinical research and drug development processesKnowledge of ICH/GCP and 21 CFR regulatory requirementsAbility to manage multiple priorities and work independentlyStrong site management, communication, and problem-solving skillsFluency in English, written and spoken, Spanish highly desiredAbility to drive and travel extensively, up to 80%, in a company vehicleDesirable RequirementsExperience in multiple therapeutic areas and Veeva Vault CTMS is a plus Advanced knowledge and use of AI The salary for this position is expected to range between $108,500 and $201,500 per year. Assigned to complex trials and/or less experienced sites, you may also act as a Subject Matter Expert, support audit and inspection readiness activities, ensure timely implementation of corrective actions, and collaborate with local and global cross-functional teams to drive process improvements that help bring innovative therapies to patients faster.
Senior Clinical Research Associate System OneSenior Clinical Research AssociatePlainsboro Township, New Jersey$115,000–$130,000 / yearTrain and support external trial staff regarding CRF and IVRS data entry, AE/SAE/MESI reporting, ethics reporting, protocol deviation identification, drug accountability, temperature monitoring, query resolution, essential document collection, and ITF filing. Collaborate with Local Trial Manager (LTM) and Line of Business Manager, communicating site progress and escalating critical issues impacting trial milestones.
Senior Clinical Research Associate - CNS - Midwest (Remote) Worldwide Clinical Trials Holdings IncSenior Clinical Research Associate - CNS - Midwest (Remote)NYRemote$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.
Associate Clinical Research Coordinator NYU Langone HealthAssociate Clinical Research CoordinatorNew York, NY$66,300Full timePrepares for upcoming study visits: research bio-specimen collection order preparation/placement, laboratory and EKG order placement, scheduling of biopsies and scans, interpreter requests, facilitating tumor assessment form completion from the investigator, QOL, AE and ConMed form completion in conjunction with a licensed professional (CRN/APP/MD) and other tasks as needed to support seamless, safe, and compliant clinical research conduct per protocol. Schedules study participants according to the approved protocol; coordinates with ancillary service providers to ensure patients remain adherent to the protocol; coordinates subjects tests and procedures in compliance with the particular protocol and with the appropriate department, and collaborates with other NYU and PCC departments to seamlessly navigate a patient to a trial and through screening, treatment and follow up/end of treatment.
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.
Inhouse Clinical Research Associate Novotech Health Holdings Pte LtdInhouse Clinical Research AssociateNY$65,000–$75,000 / yearCo-ordinate and maintain clinical study documentation in the Trial Master Files (TMF) including the tracking of documents, preparation for internal/external audits, conducting routine QC reviews and final reconciliation, according to the requirements of ICH GCP and Novotech (or client) SOPs. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.
Senior Clinical Research Associate IRESenior Clinical Research AssociateNew York, New YorkAssesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and closes clinical trials at investigative sites. Responsible for site startup activities for assigned sites, including but not limited to regulatory documents collection, informed consent review, IRB/IEC submission support, and budgets and contracts negotiations.
Senior Clinical Research Associate ICON PlcSenior Clinical Research AssociateWarren, NJICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.