Clinical Trial Associate II

3 weeks ago


New Brunswick, United States Allen Spolden Full time
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.
  • 3 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


  • New Brunswick, United States Allen Spolden Full time

    Job DescriptionThe 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...


  • New Brunswick, United States Allen Spolden Full time

    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...


  • New Brunswick, United States Allen Spolden Full time

    Job DescriptionThe 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...


  • New York, United States Cellectis Full time

    Job DescriptionWHO WE ARE Cellectis is a global clinical-stage biopharmaceutical company. Pioneers and innovators in our field, our mission is to develop innovative treatments for patients with unmet medical needs. With 25 years of expertise, we have the best-in-class gene editing platform focusing on hematology oncology, solid tumors and gene therapy....


  • New Orleans, United States Tulane University Full time

    The Clinical Research Coordinator II will coordinate and conduct the day-to-day operations of TRIAD ongoing studies in cardiovascular diseases. The Clinical Research Coordinator II is required to have an in-depth knowledge of protocol requirements and good clinical practices as set forth by federal regulations. As the primary resource for protocols, the...


  • New Haven, United States Celldex Therapeutics Full time

    Overview Join a well-established and collaborative Clinical Operations team in a Clinical Trial Manager role with opportunity for career enrichment. As the operational leader of the study team, the Clinical Trial Manager (CTM) works closely with internal team members and vendors ensuring clinical trials are completed according to protocol, SOPs,...

  • Project Manager

    1 month ago


    Hackensack, New Jersey, United States Hackensack Meridian Health Full time

    Overview: Our team members are the heart of what makes us better.   At Hackensack Meridian Health we help our patients live better, healthier lives — and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It’s also about how we...


  • New York, United States New York Blood Center Full time

    Coordinator- Clinical Trials Job Locations US-NY-New York Job ID 2024-6315 Category Administrative/Clerical Minimum Rate USD $31.43/Hr. Maximum Rate USD $34.00/Hr. Work Location Type Hybrid Overview At New York Blood Center, one of the most comprehensive blood centers in the world, our...

  • Research Associate II

    3 weeks ago


    New Brunswick, United States Rutgers University Full time

    Rutgers, The State University of New Jersey, is seeking a Research Associate II for the Rutgers Center for Advancing Research & Evaluation for Patient-Centered Care (CARE-PC) at the Robert Wood Johnson Medical School. Under the guidance of the Direct Research Associate, Research, Associate, Staff, Behavioral, Evaluation, Technology, Education


  • New York, United States New York Blood Center Full time

    Overview At New York Blood Center, one of the most comprehensive blood centers in the world, our focus is on cultivating excellence by merging cutting-edge innovation with diligent customer service, groundbreaking research, and comprehensive program and service development. Join us as we work towards meeting and exceeding the growing needs of our diverse...


  • New Brunswick, United States RWJBarnabas Health Full time

    Clinical Care Technician, Surgical Unit IIReq #:45637 Category:Nurses Aide Status:Part-Time Shift:Evening Facility:RWJ New Brunswick Department:Surgical Unit-II Location: Main Hospital - New Brunswick, One Robert Wood Johnson Place, New Brunswick, NJ 08901 RWJBH is seeking a Clinical Care Technician for our Surgical Unit II. This is a Part- Time...


  • New Brunswick, United States Rutgers University Full time

    Rutgers, The State University of New Jersey is seeking a Program Associate II for the New Jersey Agricultural Experiment Station. This position includes aspects of teaching, program planning, promotion, implementation, and evaluation; utilization of Program, Associate, Health, Education


  • New York, United States New York Blood Center Full time

    Overview: At New York Blood Center, one of the most comprehensive blood centers in the world, our focus is on cultivating excellence by merging cutting-edge innovation with diligent customer service, groundbreaking research, and comprehensive program and service development. Join us as we work towards meeting and exceeding the growing needs of our diverse...


  • New York County, New York, United States New York Blood Center Inc Full time

    Overview: At New York Blood Center, one of the most comprehensive blood centers in the world, our focus is on cultivating excellence by merging cutting-edge innovation with diligent customer service, groundbreaking research, and comprehensive program and service development. Join us as we work towards meeting and exceeding the growing needs of our diverse...


  • New Orleans, United States Tulane University Full time

    The primary responsibility of the Clinical Research Coordinator is to coordinate and conduct the day-to-day operation of clinical studies and clinical trials in cardiovascular and chronic kidney diseases. The Clinical Research Coordinator assists the investigator team to develop study protocols and manuals of procedures. The Clinical Research Coordinator...


  • New Brunswick, United States Rutgers University Full time

    Rutgers, The State University of New Jersey, is seeking a Clinic Services Representative II-Registration for the Eric B. Chandler Health Center at the Robert Wood Johnson Medical School. The primary purpose of the Clinic Service Representative II-Reg Registration, Clinic, Representative, Service, Healthcare, Education, Patient


  • New Brunswick, United States RWJ Barnabas Full time

    RWJBH is seeking a Clinical Care Technician for our Surgical Unit II. This is a Part- Time Evening 3pm-11:30pm 16 hours total per week (including every other weekend and holiday) Requirements/Qualifications: * Previous experience preferred * American Heart Association BLS required * Work under the direction of the RN to provide care to the patients on the...


  • New Orleans, United States Tulane University Full time

    The primary responsibility of the Clinical Research Coordinator is to coordinate and conduct the day-to-day operation of clinical studies and clinical trials related to maternal health and diabetes. The Clinical Research Coordinator assists the investigator team to develop study protocols and manuals of procedures. The Clinical Research Coordinator screens,...


  • New Haven, United States Yale University Full time

    The Clinical Research Coordinator II (CRC II) is responsible for providing research services to patients participating in clinical trials supported by the Yale Cancer Center Clinical Trials Office (CTO). Key responsibilities include overseeing, plann Clinical Research, Research Coordinator, Clinical, Coordinator, Research, Operations, Healthcare


  • New Haven, United States Yale University Full time

    The Clinical Research Coordinator II (CRC II) is responsible for providing research services to patients participating in clinical trials within Yale Cancer Center Clinical Trials Office (CTO). Key responsibilities include overseeing, planning, track Clinical Research, Research Coordinator, Clinical, Coordinator, Research, Operations, Healthcare