Sr. Clinical Project Manager Integrated Resources, IncSr. Clinical Project ManagerSouth Plainfield, New JerseyContractorA Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Clinical Regulatory Specialist Iterative HealthClinical Regulatory SpecialistNew York, NYYou will collaborate with site teams, internal stakeholders, sponsors, CROs, IRBs, and other external partners to ensure regulatory requirements are completed accurately, efficiently, and in accordance with applicable guidelines and study requirements. Working under the direction of a Clinical Regulatory Manager Director, you will partner closely with clinical research sites to manage regulatory activities throughout the study lifecycle—from study start-up and activation through ongoing maintenance and closeout.
Clinical Regulatory Specialist Iterative Scopes Inc.Clinical Regulatory SpecialistNew York, NYWorking under the direction of a Clinical Regulatory Manager Director, you will partner closely with clinical research sites to manage regulatory activities throughout the study lifecycle-from study start-up and activation through ongoing maintenance and closeout. You will collaborate with site teams, internal stakeholders, sponsors, CROs, IRBs, and other external partners to ensure regulatory requirements are completed accurately, efficiently, and in accordance with applicable guidelines and study requirements.
Vice President, Clinical Research FSP Consulting VitaliefVice President, Clinical Research FSP ConsultingNew Brunswick, NJRemoteProven success in building strong executive-level and C-suite relationships while leading a multi-faceted change process; demonstrated broad-based change management expertise and extensive experience positively influencing change in a variety of complex environments with multiple stakeholders and competing priorities. By blending deep subject matter expertise with strong business acumen, we deliver consulting (both operational and strategic) and Functional Service Provider (FSP) solutions that empower organizations to do more with less, streamlining operations, reducing costs, and accelerating breakthroughs that ultimately benefit patients..
Sr. Clinical Trial Associate Allen SpoldenSr. Clinical Trial AssociateNew Brunswick, New JerseyFor assigned complex, accelerated, and business essential studies, provide support to focus on study startup and site initiation activities, including: Approval of study documentation, including essential document packets, study plans, informed consent forms, etc. Work with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.
Clinical Trial Associate Allen SpoldenClinical Trial AssociateNew Brunswick, New JerseyFor assigned complex, accelerated, and business essential studies, provide support to focus on study startup and site initiation activities, including: Approval of study documentation, including essential document packets, study plans, informed consent forms, etc. Work with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.
Clinical Research Coordinator VitaliefClinical Research CoordinatorNew Brunswick, NJ$60,000–$70,000 / yearIMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that requires all on-site resources such as prospective Vitalief consultants to provide proof that they are fully vaccinated for Covid-19; inoculated annually for Influenza; and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. By blending deep subject matter expertise with strong business acumen, we deliver consulting (both operational and strategic) and Functional Service Provider (FSP) solutions that empower organizations to do more with less, streamlining operations, reducing costs, and accelerating breakthroughs that ultimately benefit patients..
Sr.Clinical Data Manager Karwell TechnologiesSr.Clinical Data ManagerEdison, NJPerform or provide oversight to staff for all CDM activities from study startup to archival: design CRFs/eCRFs, create Data Validation Specifications, Data Management Plans, eCRF Completion Guidelines, and Data Review Plans, code terms in MedDRA and WHO Drug; and complete data base lock, archival, and closeout activities. Expertise in development, validation, and management of the clinical study database throughout its life cycle, from CRF design, database development and testing, discrepancy management, data quality review and database close and lock procedures, CDASH and SDTM data formats.
NewSenior Clinical Trials Manager - European Medical Device Studies T45 LabsSenior Clinical Trials Manager - European Medical Device StudiesNew York, New YorkRemoteEnsure study conduct remains compliant with SOPs, GCP, FDA regulations, ISO 14155, EU MDR 2017/745, and other applicable European Union regulatory and ethics committee requirements, quality system requirements, and study plans. The Senior Clinical Trials Manager will lead the planning, execution, and operational oversight of multi-country medical device clinical trials across the European Union from startup through study closeout.
Manager, Clinical Study Lead Regeneron PharmaceuticalsManager, Clinical Study LeadArmonk, NY$128,600–$210,000 / yearAssigns tasks to Clinical Study Management staff and supports their deliverables; directly supervises CTM staff (work assignments, performance management, recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight); recommends and participates in cross-functional and departmental process improvements; and identifies innovative, globally informed approaches to study execution and continuous improvement of CTM SOPs. Discover your role: Leads the cross-functional study team responsible for clinical study delivery, serving as the primary point of contact for leadership and oversight, and oversees execution against planned timelines, deliverables, and budget while raising issues (conduct, quality, timelines, budget) to the Program Operations Lead and stakeholders and implementing corrective actions.
Manager Clinical Study Lead Regeneron PharmaceuticalsManager Clinical Study LeadArmonk, NY$128,600–$210,000 / yearAssigns tasks to Clinical Study Management staff and supports their deliverables; directly supervises CTM staff (work assignments, performance management, recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight); recommends and participates in cross-functional and departmental process improvements; and identifies innovative, globally informed approaches to study execution and continuous improvement of CTM SOPs. Discover your role: Leads the cross-functional study team responsible for clinical study delivery, serving as the primary point of contact for leadership and oversight, and oversees execution against planned timelines, deliverables, and budget while raising issues (conduct, quality, timelines, budget) to the Program Operations Lead and stakeholders and implementing corrective actions.
Executive Director, Clinical Research (Medical Director) Eikon Therapeutics, Inc.Executive Director, Clinical Research (Medical Director)Jersey City, NJ$304,000–$367,500 / yearThis role will require a minimum of 3 day a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. Collaborate closely with Clinical Science and other relevant functions within Eikon and potential partners including discovery, translational, and biomarker research scientists, toxicologists, clinical pharmacologists, drug safety specialists, regulatory representatives, as well as personnel from Global Clinical Operations, and other support functions.
NewClinical Research Coordinator I- Div Gen Int Medicine Mount Sinai Health SystemClinical Research Coordinator I- Div Gen Int MedicineNew York, NY$58,661–$73,530 / yearWe 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. Mount 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.
Clinical Research Coordinator I - Surgery Mount Sinai Health SystemClinical Research Coordinator I - SurgeryNew York, NY$58,661–$73,530 / 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.
Clinical Research Associate Allen SpoldenClinical Research AssociateNew York, New JerseyConduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Sr. Clinical Research Associate Allen SpoldenSr. Clinical Research AssociateChicago, New JerseyConduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Clinical Research Associate II Allen SpoldenClinical Research Associate IINewark, New JerseyConduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Senior Clinical Research Associate - Oncology IRESenior Clinical Research Associate - OncologyNew York, New York$110,520–$138,150 / yearWilling and able to travel up to 50% for on-site monitoring visits across northeast region; preference given to candidates residing in NJ / NY near major HUB airports to support efficient regional travel. Senior Clinical Research Associate - Oncology - ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
Clinical Manager, Supervised Release Program Center for Justice InnovationClinical Manager, Supervised Release ProgramBrooklyn, NYFull timetherapeutic or case management) and 2 years of supervisory experience required; Group work development and facilitation experience strongly preferred; Experience in pretrial or criminal legal system strongly preferred; Experience supporting people with specialized needs such as substance abuse treatment, mental health services, co-occurring disorders, intimate partner violence, or adolescent development strongly preferred; Therapeutic intervention training and experience preferred, including but not limited to crisis intervention or de-escalation management; Comprehensive knowledge and experience with local social service providers required; Must be detail-oriented with strong organizational and time management skills; Experience using trauma-informed and strength-based approaches strongly preferred; Training and experience with Motivational Interviewing and Cognitive Behavioral Therapy strongly preferred; Must be able to work effectively independently and as part of a highly interdependent, multi-disciplinary team within a fast-paced and dynamic work environment; Professional demeanor and ability to work collaboratively and effectively with a variety of program stakeholders, including judges, prosecutors, defense attorneys, court staff, and site partner agencies required; and. The Clinical Manager will ensure effective cross-team communication and collaboration to prioritize comprehensive and aligned service delivery; proactively identify successes, challenges, and opportunities to strengthen programming; create opportunities for meaningful collaboration, and maximize internal and external resources and expertise through a trauma-informed lens.
Senior Clinical Research Program Manager Northwell Health IncSenior Clinical Research Program ManagerLake Success, NYAdditional responsibilities for this position may include: The Cancer Center is seeking an experienced Clinical Research Project Manager/ Site Activation Specialist to oversee investigator-initiated clinical studies (IIS) conducted in collaboration with industry sponsors and external participating sites. 2.Manages the clinical research sites including, but not limited to acting as primary contact for clinical research sites for questions related to the protocol conduct protocol, regulatory document completion, study supplies, client scheduling, and electronic data capture.