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kps life · 3 days ago

Clinical Trial Associate

Milton, ME

Contract

Onsite

Senior Level

5+ years exp

KPS Life is looking to hire a Senior Clinical Trial Associate to join their embedded client teams. The role involves supporting the Clinical Operations team in planning, executing, and managing clinical trials, ensuring compliance and efficiency throughout the process.

Health CareMedicalWellness

Hiring Manager

Magda Mirowska Assoc CIPD

Responsibilities

Review site contracts, budgets, and confidentiality agreements (CDAs)

Evaluate and approve regulatory documents for IRB/EC submissions and investigational product release

Provide oversight and accountability for third-party vendors

Ensure Trial Master File (TMF) inspection readiness:

Assist in creating TMF Index and TMF Plan

Conduct periodic TMF reviews for completeness and accuracy

Support document filing, naming conventions, and archiving

Coordinate meetings, prepare agendas, and draft minutes

Track milestones, generate study metrics, and report updates to management

Liaise with CPM and other stakeholders to resolve study-related issues

Post trial information on public registries (e.g., ClinicalTrials.gov)

Ensure compliance with GCP/ICH guidelines and company SOPs

Assist in publishing clinical trial documents (protocols, amendments, investigator brochures, lab manuals)

Prepare and distribute site and internal supportive documents

Create purchase orders for vendors as needed

Contribute to SOP and work instruction development

Identify and communicate issues impacting budget, resources, and timelines

Qualification

Clinical operations experienceGCP principlesMicrosoft Office proficiencyOncology therapeutic experienceETMF systems familiarityManage multiple trialsBiological sciences degreePharmacy degreeRelated health discipline degreeGlobal studies experienceIRTEDC systems learningSupporting clinical study projects