Scope:

The Clinical Trial Associate for Study Start-up (SSU CTA) assists in the delivery of site start up activities for assigned studies from site identification through activation working in collaboration with the Clinical Study Lead (s) and is an active member of the study team(s).

Key Responsibilities:

• The SSU CTA supports the collaboration with CPMs, CRAs, Clinical Business Operations, Medical Affairs, study sites, study team and CRO, if applicable, to ensure that site activation is achieved in a timely and efficient manner based on timelines set by the study team and in consideration of local activation process requirements.
• 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.
• 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
• Assists the SSU Manager in generating and updating the study site activation plan across countries and sites based on the study priorities detailing country and site-specific requirements and planned dates.
• Supports review of and modifications to the study start-up processes to ensure quality and efficiency.
• Assists the SSU Manager in their applicable functions and CROs as applicable with regulatory interactions related to submissions and approval processes across multiple countries.
• Collects and maintains essential documentation in compliance with ICH-GCP and ensures filing in TMF.
• Tracks budget and contract negotiations/executions in collaboration with CPM, CBO and other relevant stakeholders (i.e., Legal, ClinOps, etc.),
• Assists the SSU Associate Director in producing and collecting site-specific contracts, ICFs and CDAs from country and/or master template.
• Supports the SSU Associate Director in communicating site prioritization regarding Study Site Contract completion/execution to meet Study Activation Plan.
• Tracks and reports metrics of study site progress towards activation at relevant meetings.
• Proactively identifies delays in start-up activities, the risks to the activation plan and supports the SSU Associate Director in developing collaborative mitigation strategies for the study team to implement.
• Perform other duties as assigned.

Professional Experience/Qualifications:
• Bachelor's degree (scientific or healthcare discipline preferred) or equivalent industry experience
• A minimum of 1 year of related experience is preferred
• Strong 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.
• Knowledge and experience with Trial Master Files (TMF) and experience with electronic TMF systems (i.e., Veeva) is preferred
• Knowledge of Site Start-up activities in clinical research is preferred

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.

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.