Clinical Trial Associate

Company: Disability Solutions
Location: Princeton
Posted on: September 1, 2024

Job Description:

Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: . Job Description Summary This position manages administrative and business activities to support the regulatory and procedural requirements necessary for US investigative trial sites to conduct clinical trials, with accountability of executing these activities from study startup to study closure.Key Responsibilities and Major Duties

• Setting up vendors during study startup period (operational details from sites)
• Enter necessary data / tracking in systems (i.e.CTMS, eTMF, SAP)
• Responsible for documentation within the electronic master file (uploading / completing documents) & other systems (i.e., document exchange portals like Shared Investigator Portal) including conduct of completeness checks
• Arranging drug and non-drug (Lab kits, ECG) importation to support study site
• Complete all payment activities including preparing invoices, Payment Due Reports and creating fund/PO
• Collect and distribute documents from / to sites during study life cycle
• Coordinate study related materials (i.e. protocol, Informed Consent Form(ICF), patient material) for translation
• Coordinate study related documents (IB, Protocol, Site ICF etc.) for printing and binding
• Administrative support to the study team (study related mailing, bill processing, printing, translation etc.)
• Obtain Insurance certificates
• Preparing On Site Investigator File and other study related files
• Support equipment calibration and tracking
• Archiving process handling at study closure
• May support Local GRS in preparing and/or performing submission for Health Authorities including follow up until approval. This could include preparation and/or submission of substantial amendments.
• May prepare and perform submission for Ethics Committees including follow up until approval (protocol, amendments/IB)
• May support Health Authority inspection and pre-inspection activities
• May support audit preparation & Corrective Action / Preventative Action preparation for local related issues(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)
  • Key Stakeholders/Contacts - describe this position's key internal matrix relationships and key external stakeholders/clients
  • External: Clinical Study Sites, Institutional Review Boards/Ethics Committees, Vendors, Contract Research Organizations, GCP Officer (China only)
  • Internal: Global Trial Manager (GTM), Clinical Trial Managers (CTMs) Clinical Trial Monitors (CTMos), Study Start-up Specialists, Site Contract Leads, Vendor Operations Managers, Regional Clinical Compliance Leads, Line Managers, Heads of Clinical Operations and Local RegulatoryDegree Requirements: Bachelor's degree within Life Sciences area, Administrative, Financial or Accounting related field preferred or minimum 2 years working experience in any of these areas in addition to high school degree or local equivalent. Experience Requirements:
    • CTA: 1 - 3 years' experience in Clinical Research or related work experience.
    • Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems or equivalent preferred
    • Additional complex software application related to clinical trial research (i.e electronic data capture or patient diaries, interactive voice response, etc...) preferredKey Competencies:
      • Basic understanding of GCPs, ICH Guidelines and local regulations as they apply.
      • Basic knowledge of the drug development process as it relates to the execution of clinical trials with a focus on document flow.
      • Experience in managing multiple priorities and able to accomplish tasks within a timeframe, setting milestones to meet deadlines and to achieve goals.
      • Demonstrates ability to function independently
      • General knowledge of software systems and web-based applications. Good computer aptitude and willingness to learn new systems and applications.
      • Good verbal and written communication skills (both in English and local language).
      • Microsoft Suite
      • Clinical Trial Management System (CTMS)
      • Electronic Trial Master File System (eTMF)
      • Document Exchange Portals If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients' lives through science--- , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site Protocol BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Keywords: Disability Solutions, Trenton , Clinical Trial Associate, Healthcare , Princeton, New Jersey