We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Clinical Trail Associate. The Clinical Trial Associate (CTA) will be 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.

Job Duties and 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.

Key Core Competencies

• 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.

Education and Experience

• 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.

The base salary range for this role is $70,400 to $88,000. 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 unlimited 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.

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. 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.