Study Implementation Associate
Curavit Clinical Research is currently seeking a full-time Study Implementation Associate. The Study Implementation Associate turns study designs into high-quality, compliant study builds across EDCs and Clinical Trial Management Systems. Partnering with study design, clinical operations and data management, this role owns study builds and user acceptance testing (UAT) from setup through go-live, and supports studies through amendments to closeout. The Study Implementation Associate is a hands-on role for a logical, detail-driven problem solver who turns complex study designs into quality, streamlined builds.
Primary Responsibilities:
Build studies in trial platforms per approved build specifications, including eCRFs, visit schedules, edit checks, derivations, randomization and user roles.
Program and test edit-check and validation logic against the data validation plan.
Complete build deliverables on agreed timelines and hand over builds ready for UAT.Execute UAT and build verification for in-house builds, and support UAT on vendor-built EDCs.
Implement post-go-live changes and protocol amendments, including migration testing.
Resolve build and configuration issues during study setup and deployment.
Identify gaps or ambiguities in build specifications and raise them with the study design team before building.
Maintain accurate build documentation, audit trails and validation evidence in line with GCP and 21 CFR Part 11.Contribute to build standards, reusable libraries and templates to improve build speed and quality.
Provide feedback on specification quality and platform limitations to the study design and product teams.
Knowledge, Qualifications, and Skills:
Bachelor's degree in life sciences, computer science, health informatics or a related field preferred; a combination of education and relevant experience may be substituted.
Hands-on experience building studies in an EDC system.
Experience testing edit checks or validation logic.
Experience executing UAT and documenting test evidence.
Working knowledge of GCP and 21 CFR Part 11.Exceptional attention to detail, with the ability to spot gaps and ambiguities in build specifications.
Ability to manage own build timelines and communicate clearly when work is blocked.
Experience with decentralized or hybrid clinical trials is a strong plus.
Competencies Teamwork: The characteristic of an individual to work effectively in a team while motivating others to do the same for achievement of common goals of the team.
Communication: Strong written and verbal communication skills, including the ability to translate technical issues into clear, actionable updates for clinical and operational teams. Attention to Detail: The ability to work accurately and thoroughly, catching errors and inconsistencies before they reach a live study.
Quality & Compliance: A commitment to getting work right the first time and documenting it to the standards expected in a regulated environment.
Problem Solving: The ability to work through issues with calm composure, critical thinking and the information available.
Result Orientation: Knows how to set ambitious goals that are realistic and achievable by defining steps and bringing results.
Organizational Excellence: The ability to understand and carry out allocated tasks and responsibilities in a timely and consistent manner and deliver results.
Customer Orientation: The demonstrated capability of delighting one’s customers by focusing on their needs and ensuring that the customer perspective is the driving force behind all value-added business activities.
Commercial Awareness: The ability to understand what makes a business or organization successful and staying up-to-date on daily happenings and developments in the business and commercial world.
Cultural Competence: The demonstrated capability to interface, partner and work effectively with stakeholders across a diverse set of cultures, individual characteristics and personalities.
Location: Remote US - Home based Employment Type: Full time
Equal Opportunity Statement Curavit Clinical Research is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected status.