Jobs
>
New Brunswick

    Sr. Clinical Trial Associate - New Brunswick, United States - Allen Spolden

    Default job background
    Description
    Job Description
    The remote-based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy and and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan.
    • Provide support for essential daily clinical study activities, including regulatory inspection readiness, following established protocols under the general management of the CTA Manager.
    • 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.
    • Perform departmental tasks.
    • Perform developmental tasks with oversight of CTA Manager.
    ACCOUNTABILITIES:

    For 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.
    • Support oversight of risk-based monitoring.
    • Attend important team meetings.
    • Support regulatory inspection readiness (e.g. preparation of materials and participation during regulatory inspections.)
    • Support additional ad-hoc activities, as agreed with CTA Manager.
    • Work with internal departments (Legal, Insurance, R&D functions), CROs, and vendors.
    • Escalate clinical trial insurance issues.
    • Support Health Care Provider Engagement for facilitating contracts and meetings.
    • Support vendor contract administration.
    Requirements
    • Bachelor's degree or equivalent international degree.
    • 5 or more years' experience in pharmaceutical industry, clinical research organization, or related role.
    • Experience in Phase 2 and 3 studies and global/international studies is advantageous.
    • Experience working across multiple therapeutic areas is advantageous.
    • Knowledge in global regulatory and compliance requirements for clinical research.
    • Excellence in task management and collaboration.
    • Requires availability for 5-10% domestic and international travel, including overnight and international travel on an as-needed basis.
    Benefits
    • 401(k) with company match and Annual Retirement Contribution Plan
    • Tuition reimbursement Company match of charitable contributions
    • Health & Wellness programs including onsite flu shots and health screenings
    • Generous time off for vacation and the option to purchase additional vacation days
    • Community Outreach Programs


  • Allen Spolden New Brunswick, United States

    Job Description · The remote-based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy and and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan.Provide support for essential daily clinical ...


  • Public Employment Relations Board Brooklyn, United States

    **Minimum Qualifications** · Admission to the New York State Bar and six years of substantial experience in the field of labor-management law and labor-management relations primarily under the Taylor Law or similar collective bargaining laws including but not limited to experienc ...


  • Lupus Research Alliance Inc. New York, United States

    **Associate Clinical Trial Manager, Lupus Therapeutics (Contract basis)** · **Location**: Remote · **Remuneration**: $100/hour, up to 25 hours per week · **Background** · The Lupus Research Alliance (LRA) is the world's leading non-governmental, non-profit funder of lupus researc ...


  • Allen Spolden Raleigh, United States

    Job Description · The Office-Based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy and and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan. This is a position with a pharmaceutical com ...


  • Allen Spolden New Brunswick, United States

    Job Description · The remote-based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy and and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan.Provide support for essential daily clinical ...


  • PrideStaff Edison, United States

    We represent a firm with a fulltime, direct hire Personal Injury Trial Associate opportunity in Edison, NJ. Salary: $80 - $100 k (depending on experience)Schedule: fully onsite Mon - Fri Personal Injury Trial Associate Requirements:1-3 years of pers Associate, Personal, Retail, S ...


  • Novo Nordisk A/S Plainsboro, United States

    Takes ownership to deliver upon near-term North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex cross-functional improvement/innovat Clinical, Management, Associa ...


  • Audrey Golden Associates Ltd. New York, United States

    Prominent trial boutique headed by former Big Law partner is seeking a Litigation Associate to join its busy and active trial practice. The firm represents Fortune 100 companies in highly complex and unique commercial and civil cases. Qualified candidates should have 5-8 years of ...


  • UroGen Princeton, United States

    Job Description · Job DescriptionSalary: $60K to $75K/Annual · Job Summary · The CTA will function in a key supporting role for the clinical team in all administrative aspects of the clinical projects assigned in accordance with GCP and regulatory authority guidance to ensure the ...


  • Sun Pharmaceutical Industries Princeton, United States

    COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE · * Hybrid work arrangement · * Medical, Dental, Vision Benefits · * Health Savings Account (HSA), Flexible Spending Account (FSA) · * Prescription Drug Coverage · * Telehealth and Behavior Health Services · * Income Pr ...


  • New York State Civil Service Brooklyn, United States

    NY HELP No · Agency Public Employment Relations Board · Title Associate Trial Examiner (ALJ) · Occupational Category Legal · Salary Grade 663 · Bargaining Unit M/C - Management / Confidential (Unrepresented) · Salary Range From $111925 to $141439 Annually · Employment Type ...


  • Novo Nordisk Plainsboro, United States Full time

    About the Department · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to ...


  • BioSpace Plainsboro, United States

    Job Details · About the Department · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies wi ...


  • State of New York Brooklyn, United States

    Please note: State agencies that contact job applicants do not usually request personal or financial information via text message or over the phone in connection with your response to a job posting. If you are contacted for such information by these methods, or any other method, ...


  • GENMAB A/S Princeton, United States

    At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...


  • Genmab A/S Trenton, United States

    The Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at · . · Senior Clinical Trial Associate page is loaded · Senior Clinical Trial Associate · Apply · locations · Utrec ...


  • Javara New Brunswick, United States

    **This is an on-site position in Annapolis, MD. The salary range starts at $107,000 and is based on experience. Relocation assistance is provided.** · **Summary**: · As the Manager, Site Operations, you will be responsible for comprehensive operational and relationship management ...


  • StaffingForce New York, United States

    Job Description · Job DescriptionMajor domestic and international law firm seeks a Litigation & Trial focused Associate Attorney with 2-4 years of experience (JD class 2020, 2021, or 2022) to join its New York office. · Candidate will have the following: 2-4 years of general comm ...

  • Thermo Fisher Scientific

    Labs Fsp

    1 week ago


    Thermo Fisher Scientific New Brunswick, United States

    **Title: Labs FSP - Associate Research Scientist - Project Management** · **Location: New Brunswick, NJ** · - **This is a Monday**-Friday position on first shift, hybrid position.** · At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a g ...

  • Boehringer Ingelheim Animal Health USA

    Ad, Bioanalysis

    1 week ago


    Boehringer Ingelheim Animal Health USA North Brunswick, United States

    The Associate Director, Bioanalysis is responsible for providing expertise in the areas of Ligand binding assay method development and sample analysis, representing Bioanalysis on the project team. Expertise in Mass Spectrometry, Ultra High-Performance Liquid Chromatography, plas ...