Associate Clinical Research Scientist

The Associate Clinical Research Scientist (ACRS) supports the execution of the clinical studies that make up the company’s clinical evidence generation program. In this role, you will support and facilitate the execution of clinical studies and/or programs worldwide under the direction of a CRS or Sr CRS, and in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures.

The ACRS interacts and liaises closely with the cross‑functional teams, including CRS and Sr CRS, Disease State Scientists, Data Management and Biostatistics, Regional Medical Affairs teams and other stakeholders to facilitate, review, and provide input to study documents, strategies and plans.

The ACRS may have responsibility for clinical monitoring activities under the supervision of CRS/Sr CRS and for liaising with external vendors.

This role is crucial in maintaining our commitment to clinical research excellence and patient‑centric approaches.

This role can be located in either St. Louis, MO OR Salt Lake City, UT.

• Study Documentation, Planning, Strategy and Reporting:
  • a. Supports the CRS or Sr CRS in the collection and delivery of documentation to meet study milestones and performance, including study plans for non‑registration Investigator Initiated Research (IIR), clinical study project plans, study execution plans, risk and risk mitigation plans, and monitoring plans.
  • b. Responsible for study documentation filing in corporate systems and according to GCP guidelines.
  • c. Contributes to the development, documentation, and management of study budgets and timelines, as directed by the CRS or Sr CRS.
  • d. Reviews and provides input to the development of IIR/CIR study protocols.
  • e. Assists in compiling monthly status and dashboard reports.
• Study Management and Site Management:
  • a. Assists in the management of IIR studies from proposals submission to study close‑out.
  • b. Supports the project team in the management of aspects of clinical trial operations including study start‑up, site initiation, patient enrollment, monitoring, and study close‑out for BIR / CIR studies as directed by the CRS or Sr CRS.
  • c. Facilitates tracking of study progress and provides regular status reports to the study team.
  • d. As directed, input study and site information, metrics and budget tracking information into relevant BioMérieux systems.
  • e. Updates trial management systems, including timelines and budgets. Contribute to site selection, feasibility, study startup, site activation, enrollment, and ongoing execution.
  • f. Manages the coordination of logistics and training needed to execute studies.
  • g. Conducts clinical monitoring as directed and required including on‑site and remote site qualification visits, site initiation visits, interim monitoring visits and site close‑out visits.
  • h. Supports the CRS / Sr CRS in overseeing clinical site activities, reference laboratories, contract research organizations (CROs), and other external partners to ensure adherence and compliance with protocol timelines, budgets, study milestones and quality standards.
  • i. Supports and coordinate IRB/EC document creations and communications.
  • j. Supports the execution of clinical trial agreements for sites.
• Regulatory Compliance:
  • a. Follow Corporate (e.g., SOP’s) and local/regional regulatory requirements.
  • b. Participate in the review and revision of Clinical Operations Standard Operating Procedures (SOPs) to assist Medical Affairs leadership with continuous process improvement initiatives.
• Quality and Compliance:
  • a. Supports the team as directed in managing risks throughout the clinical trial lifecycle.
• Data Management:
  • a. Participate in the setup and management of electronic data capture (EDC) systems.
  • b. Assist in data collection and data clarification activities as directed.
  • c. Supports any inspection readiness activities as directed by the CRS / Sr CRS.
• Communication:
  • a. Assist in the conduct of internal and external study meetings as directed.
  • b. Communicate with cross functional team members regarding study status, issues and reporting.
  • c. Participate in core team meetings to provide input.
• Vendor…