Clinical Trial Associate

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 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.

Key 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.

Knowledge, Skills, and Abilities

• 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.

Professional Experience/Qualifications:

• 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.

The base salary range for this role is

$72,500.00 - $90,600.00

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. Total 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 law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. 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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Mental/Physical Requirements:

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:

Primarily remote role with periodic on-site meetings in office. 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.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer

Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at [email protected] . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

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 or follow us on LinkedIn.

Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at [email protected]

This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

SMPA may use Artificial Intelligence ("AI") as part of the job application process, including to assist us in evaluating your application. By submitting your information, you acknowledge that the company may use AI tools as part of our evaluation.

At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.

Our Mission

To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide

Our Vision

For Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas