Scope:

The Clinical Trial Associate (CTA) plays a key role in supporting the operational and regulatory execution of clinical trials, acting as a central resource to study teams, and handling administrative aspects of clinical trial execution. This position is responsible for coordinating study documentation, tracking essential project milestones, and ensuring the integrity and compliance of trial records in alignment with Clinical Standard Operating Procedures and Good Clinical Practice (ICH) Guidelines. The CTA utilizes specialized knowledge and critical thinking skills to identify, communicate, and resolve study-related compliance or operational issues. The CTA also contributes to process improvement initiatives and supports the preparedness of clinical trials for audits and regulatory inspections. This position requires the ability to work independently within established procedures, exercise sound judgment, and make recommendations to ensure study quality, accuracy, and regulatory readiness.

Key Responsibilities:

• Support the execution and maintenance of clinical trials by performing essential study tracking, document coordination, and communication activities, ensuring regulatory compliance and adherence to the study protocol.
• Review, organize, and ensure accuracy of key study documents (e.g., informed consent forms, regulatory documents, essential document packets) in accordance with established standards and SOPs. Identify discrepancies and proactively work with sites or team members to resolve issues, escalating when appropriate.
• Maintain and update critical study trackers, databases, and platforms (such as electronic Trial Master File systems) to ensure real-time accuracy and audit readiness. Apply subject matter knowledge to identify potential risks to document completeness or compliance and recommend process improvements.
• Monitor overall study progress by regularly collecting and synthesizing data on site status, enrollment, training completion, and regulatory submissions. Provide timely and concise updates to the team and partner functions to facilitate effective decision-making.
• Coordinate and prepare materials for study meetings (including drafting agendas, taking minutes, and following up on action items) to support cross-functional communication, alignment, and compliance.
• Manage the logistical aspects of clinical trial materials, including clinical and non-clinical supplies and laboratory sample shipment coordination, ensuring chain of custody and protocol requirements are met.
• Assist with the implementation of training for site personnel and vendors on study-specific procedures, leveraging knowledge of protocol requirements and regulatory guidelines.
• Contribute to the ongoing development and continuous improvement of departmental procedures, including participation in SOP reviews and recommendations based on study experience.
• Work independently within defined procedures, exercising discretion and sound judgment to resolve routine issues, and escalate matters with potential impact to study quality or milestone achievement.
• Assist or back up the Clinical Regulatory Operations Specialist in periodic quality control review and overall maintenance of the Trial Master File to ensure regulatory and inspection readiness.
• Perform other study-related duties and projects as assigned.

Professional Experience/Qualifications:

• Bachelor's degree in a scientific, healthcare, or related discipline required; equivalent combination of education and experience may be considered.
• Minimum of 1 year of related experience in clinical research, healthcare, or life sciences preferred; open to qualified entry-level candidates with relevant internship or academic project experience.
• Proficient computer skills, including Microsoft Office (Word, Excel, PowerPoint, Outlook), and familiarity with project management and collaboration tools (e.g., Smartsheet, MS Project, SharePoint).
• Demonstrated ability to independently manage multiple priorities and work efficiently in a fast-paced, deadline-driven environment.
• Strong written and verbal communication skills, including the ability to effectively interact with cross-functional teams and stakeholders at all levels.
• Excellent interpersonal and teamwork skills to foster positive, collaborative relationships with internal teams and external partners.
• Strong organizational skills and attention to detail, with the ability to proactively resolve issues and ensure accuracy in all work.
• Excellent writing skills for creation and review of file notes, meeting minutes, communications, and study documentation.

The base salary range for this role is

$72,900.00 - $91,100.00

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.

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.