- Hackensack Meridian Health (Neptune City, NJ)
- …transform healthcare and serve as a leader of positive change. The ** Senior Clinical Research Coordinator** is responsible for coordinating and overseeing clinical ... out the research and works under the general supervision of the principal investigator responsible for the clinical trial(s) to which the role is assigned. This… more
- Deloitte (Princeton, NJ)
- …case dispositions + Holding meetings with Project Leadership to discuss investigator performance, issue management, and case escalation decisions + Providing ... related software + 4+ Years Experience submitting written and oral reports to senior management and clients + Bachelor's degree in Finance, Business, Law, Criminal… more
- Merck (Rahway, NJ)
- …trial level plans/timelines, country/site selection, site materials, system updates, investigator meeting planning, communication plans, preparation of status update ... reports, study close out activities). + Leads team for timeline management, risk identification and mitigation, issue resolution. + May facilitate and collaborate with key internal/external stakeholders (eg, study team, country teams, vendors, committees) in… more
- Merck (Trenton, NJ)
- …+ Worldwide marketing applications + Clinical study protocols and reports + Investigator brochures + Local registration study protocols for secondary markets + ... Represent Global Regulatory Affairs on internal committees (eg, DRC, ADT/PDT, EDT, LEAD) to provide strategic regulatory input and approvals. + Conduct initial content review and approval for IND/CSA submissions to enable clinical trial initiation. +… more
- WuXi AppTec (Cranbury, NJ)
- …review as SOP and protocol required + Function as a Principal Investigator , responsible for pathology-related activities + Conduct planned, long-term education and ... training for junior pathologists + Communicate with sponsors to answer questions and discuss results regarding the pathology report. + Provide consultation to Study Directors on studies. + Ensure the compliance of various GLPs, comply with protocol and SOPs… more
- IQVIA (Parsippany, NJ)
- …are available for filing in the Trial Master File (TMF) and verify that the Investigator 's Site File (ISF) is maintained in accordance with GCP / ICH and local ... regulatory requirements. * Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. * Act as a… more
- Merck (Rahway, NJ)
- …and to improve outcomes for patients. The EDSA leads a large investigator -initiated studies program in partnership with late-stage development teams in Medical ... Congress summary reports. **Primary Responsibilities:** + Leads our Company's Investigator Initiated Studies program in assigned therapeutic areas ensuring… more
- Organon & Co. (Jersey City, NJ)
- …Associate Director, Global Regulatory Lead (GRL), reporting to the Executive Director, Senior Director or Director, Global Therapeutic Area Leader (GTAL), will be ... but not limited to US-FDA or EU procedures (centralized, mutual recognition , decentralized) + Independently manage projects within their assigned therapeutic area… more
- Sumitomo Pharma (Trenton, NJ)
- …evaluation reports according to established safety governance policies and keeping senior leadership informed of safety issues. **Job Duties and Responsibilities** + ... Forms (ICF), Safety Management Plans (SMP), Clinical Study Reports (CSR), Investigator 's Brochures (IB), Investigator communications (Dear Health Care Provider… more
- Vitalief (New Brunswick, NJ)
- …provide you with an opportunity to significantly contribute to our growth and recognition in the clinical research industry by fulfilling our clients' business needs ... approval; Final Preparation - Final approvals by the Principal Investigator & Sponsor. + Take a lead role in...leader (functioning as a player-coach), working closely with client senior leaders and directing the Vitalief delivery team, ensuring… more