Clinical Trial Associate

Sumitomo Pharma • Marlborough, MA

15h • Remote

About The Position

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. 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.

Requirements

• 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. (scientific or healthcare discipline preferred)
• A minimum of 1 year of related experience is preferred, open to entry level candidates
• Solid computer skills in Office, Word Excel, Project, Smartsheet, and other applicable applications.
• Ability to work in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands.
• Excellent communication and interpersonal skills are essential as the CTA interacts with many people of varying levels of responsibility for clinical trial programs.
• Able to collaborate effectively with internal and external study management teams to meet project timelines.
• Excellent writing skills to assist with creation of file notes, team communications, and other documents as assigned.

Nice To Haves

• Foundational knowledge of clinical research and/or experience in research setting – not required but a bonus.

Responsibilities

• 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.
• 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)
• Will assist/back-up the Clinical Regulatory Operations Specialist for overall quality, maintenance, and completeness of Trial Master Files.
• Perform other duties as assigned.

Benefits

• Base 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 state.
• Our 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 thereafter.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level