Sr. Clinical Trial Associate

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.
  • 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

  • Sr. Clinical Trial Associate

    4 weeks ago

    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...

  • Clinical Trial Associate

    1 month ago

    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...

  • Clinical Trial Associate

    4 weeks ago

    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...

  • Clinical Trial Associate II

    4 weeks ago

    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...

  • Clinical Trial Specialist

    4 days ago

    New Brunswick, United States Vitalief Full time

    WHY VITALIEF?Vitalief is a pioneering consultancy addressing the healthcare human capital epidemic. Join us and help clients adapt to evolving requirements in the research and clinical trial industry with cutting-edge solutions. Reasons to Work for Vitalief:Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees.We...

  • Director, Clinical Trials

    3 days ago

    New Brunswick, United States Vitalief Full time

    Job DescriptionJob DescriptionOverviewVitalief is a pioneering, “best of breed” Research and Clinical Trial Solutions Consulting Company.  We are seeking a problem-solving oriented, “hands-on” strategic solutions professional to become an integral member of our exceptional Client Services Delivery team.  The Director will work closely with senior...

  • Director, Clinical Trials

    3 days ago

    New Brunswick, United States Vitalief Full time

    Job DescriptionJob DescriptionOverviewVitalief is a pioneering, “best of breed” Research and Clinical Trial Solutions Consulting Company.  We are seeking a problem-solving oriented, “hands-on” strategic solutions professional to become an integral member of our exceptional Client Services Delivery team.  The Director will work closely with senior...

  • Clinical Trial Specialist

    3 days ago

    New Brunswick, United States Vitalief Full time

    Job DescriptionJob DescriptionWHY VITALIEF?Vitalief is a pioneering consultancy addressing the healthcare human capital epidemic.  Join us and help clients adapt to evolving requirements in the research and clinical trial industry with cutting-edge solutions.  Reasons to Work for Vitalief:Our PEOPLE FIRST culture prioritizes personal and professional...

  • Clinical Trial Specialist

    5 days ago

    New Brunswick, United States Vitalief Full time

    WHY VITALIEF?Vitalief is a pioneering consultancy addressing the healthcare human capital epidemic.  Join us and help clients adapt to evolving requirements in the research and clinical trial industry with cutting-edge solutions.  Reasons to Work for Vitalief:Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief...

  • Senior Financial Analyst, Clinical Trials

    4 days ago

    New Brunswick, United States Vitalief Full time

    Job DescriptionJob DescriptionWHY VITALIEF?Vitalief was formed to address the human capital epidemic the Healthcare industry is facing today. We are expanding our footprint rapidly as a value-add, innovative Healthcare, Research and Clinical Trials Consulting Company.  As a result, we are seeking talented and enthusiastic healthcare professionals to join...

  • Manager, Site Operations

    5 days ago

    New Brunswick, United States Javara Full time

    ***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 of clinical trial activities associated with our healthcare partnerships. With a guiding...

  • Clinical Trial Associate, Oncology, EMEA

    4 days ago

    New York, United States Eikon Therapeutics, Inc. Full time

    Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of...

  • Clinical Trial Manager

    4 days ago

    New York, United States Intra-Cellular Therapies, Inc Full time

    Benefits Offered 401K, Dental, Life, Medical, Vision Employment Type Full-Time "We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders" Intra-Cellular Therapies Inc. is a publicly traded biopharmaceutical company headquartered in New York City. Founded on Nobel-prize winning...

  • Clinical Trial Manager

    4 days ago

    New York, United States BioSpace Full time

    Job DetailsBenefits Offered401K, Dental, Life, Medical, VisionEmployment TypeFull-Time"We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders"Intra-Cellular Therapies Inc. is a publicly traded biopharmaceutical company headquartered in New York City. Founded on Nobel-prize winning...

  • Clinical Trial Manager

    4 days ago

    New York, United States INTRA-CELLULAR THERAPIES INC Full time

    Job DescriptionJob DescriptionBenefits Offered401K, Dental, Life, Medical, VisionEmployment TypeFull-Time“We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders”Intra-Cellular Therapies Inc. is a publicly traded biopharmaceutical company headquartered in New York City. Founded...

  • Clinical Trial Manager

    2 days ago

    New York City, United States Intra-Cellular Therapies, Inc. Full time

     Benefits Offered401K, Dental, Life, Medical, VisionEmployment TypeFull-Time“We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders”Intra-Cellular Therapies Inc. is a publicly traded biopharmaceutical company headquartered in New York City. Founded on Nobel-prize winning...

  • Director, Clinical Trial Management

    5 days ago

    New York, United States Intra-Cellular Therapies, Inc Full time

    _Benefits Offered_ _401K, Dental, Life, Medical, Vision_ _Employment Type_ _Full-Time_ "We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders." Intra-Cellular Therapies Inc. is a publicly traded biopharmaceutical company headquartered in New York City. Founded on Nobel-prize...

  • Clinical Trial Manager

    4 weeks ago

    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,...

  • Director, Clinical Trial Management

    4 days ago

    New York, United States INTRA-CELLULAR THERAPIES INC Full time

    Job DescriptionJob DescriptionBenefits Offered401K, Dental, Life, Medical, VisionEmployment TypeFull-Time“We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders.”Intra-Cellular Therapies Inc. is a publicly traded biopharmaceutical company headquartered in New York City. Founded...

  • Director, Clinical Trial Management

    4 days ago

    New York, United States BioSpace Full time

    Job DetailsBenefits Offered 401K, Dental, Life, Medical, Vision Employment Type Full-Time "We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders."Intra-Cellular Therapies Inc. is a publicly traded biopharmaceutical company headquartered in New York City. Founded on Nobel-prize...