Clinical Trial Associate

Sumitomo Pharma

Olympia, WAFull-time

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Benefits

$72,500.00 - $90,600.00Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work stateOur robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafterTotal compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law1 more items(s)

Qualifications

  • •Problem solving study-related issues; demonstrating resourcefulness and independence; escalation of issues as needed
  • •Should have knowledge and experience with Trial Master Files (TMF) and experience with electronic TMF systems. (i.e., Veeva)
  • •**Foundational knowledge of clinical research** **and/or experience in research setting** - not required but a bonus
  • •**Exceptional organizational skills** and attention to detail; able to manage multiple priorities and timelines effectively
  • •**Strong written and verbal communication skills;** ability to interact professionally within a cross-functional team environment
  • •**Adept at learning new systems and technologies.** (i.e., eTMF, CTMS, or similar platforms)
  • •**Proficient with standard office software
  • •** (Microsoft Office suite; Outlook, Excel, Word, PowerPoint)
  • •**Demonstrated ability to work independently and as a team player** in a fast-paced environment
  • •**Critical thinking and problem-solving abilities.**
  • •**Ability to maintain confidentiality** and adhere to high ethical standards
  • •Bachelor's degree or equivalent curriculum
  • •Fast-paced environment handling multiple demands is involved
  • •Must be able to exercise appropriate judgment as necessary
  • •Requires a high level of initiative and independence
  • •Excellent written and oral communication skills required
  • •Requires ability to use a personal computer for extended periods of time
  • •*Travel Requirements:**
  • •Must be able to travel domestically and internationally as needed
  • •*Drug Screening Requirements**
  • •Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test
  • •18 more items(s)

Responsibilities

  • •The Clinical Trial Associate (CTA) is responsible for supporting the conduct of clinical trials and handling administrative aspects of clinical trial execution
  • •This role will support completion of all study deliverables, ensuring the highest level of data quality; proactively identifies, communicates, and resolves clinical study operational issues; and participates in process improvement initiatives as required
  • •This role adheres to Clinical Standard Operating Procedures and Good Clinical Practice ICH Guidelines
  • •Perform general administrative tasks to support team members with clinical trial execution, e.g., development and formatting of documents, review and reconciliation of study- specific information, etc
  • •Assist in maintaining study status updates on a weekly basis
  • •(e.g., IRB approvals, regulatory document collection, patient enrollment, monitoring status, etc.)
  • •Track and prepare study-specific information using databases, spreadsheets, and other tools
  • •Review and/or approval of study documentation, including essential document packets, study plans, informed consent forms, etc
  • •Manage clinical and non-clinical supplies, including purchase and shipping
  • •Help with the development and distribution of site binders
  • •Set-up and coordinate meetings, take and distribute meeting minutes
  • •Support protocol and study-specific training with vendors, site personnel, and clinical sites
  • •Coordinating the movement of laboratory samples between clinical sites and central laboratories and tracking the status of samples and resulting laboratory data
  • •Ability to work with timelines and complete tasks according to deadline
  • •Will assist/back-up the Clinical Regulatory Operations Specialist for overall quality, maintenance, and completeness of Trial Master Files
  • •Perform other duties as assigned
  • •Excellent writing skills to assist with creation of file notes, team communications, and other documents as assigned
  • •All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed
  • •*Confidential Data:*
  • •All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law
  • •*Compliance:*
  • •Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards
  • •Primarily remote role with periodic on-site meetings in office
  • •20 more items(s)
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