Clinical Trial Associate

 and development to bring novel therapies to patients sooner.

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 identify, communicate, and resolve clinical study operational issues; and participate 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.
• Assist in maintaining study status updates on a weekly basis. (e.g., IRB approvals, regulatory document collection, patient enrollment, monitoring status)
• 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.
• 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.
• Coordinate the movement of laboratory samples between clinical sites and central laboratories and track the status of samples and resulting laboratory data.
• Work with timelines and complete tasks according to deadline; problem‑solve study‑related issues; demonstrate resourcefulness and independence; and escape issues as needed.
• Have knowledge and experience with Trial Master Files (TMF) and experience with electronic TMF systems (e.g., Veeva).
• 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 a 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 (e.g., 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.

Salary and Benefits

Base salary range: $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 shutdown 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.

Travel Requirements

Primarily remote role with periodic on‑site meetings in office. Must be able to travel domestically and internationally as needed.

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.

Drug Screening Requirements

Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre‑employment drug test.

Equal Employment Opportunity

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.

Accessibility

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.