Clinical Operations Coordinator 2929 N Commerce Pkwy, Miramar, FL 33025 $50,000
- $58,000 a year
- Full-time $50,000
- $58,000 a year
- Full-time HCW Biologics is an innovative immunotherapy company developing novel therapeutics designed to disrupt the link between chronic, low-grade inflammation and age-related disorders.
This field, known as inflammaging, targets the unresolved inflammatory responses and chronic, low-grade inflammation associated with advancing age and believed to be a significant contributing factor to cancer and several chronic conditions, including cardiovascular disease, diabetes, neurodegenerative disease, and autoimmune disease. Job Summary The Clinical Operations Coordinator (COC) is an important member of the HCW Biologics Clinical Operations (CO) team. The CO team is responsible for the execution of all HCW's clinical trials
- active and in the pipeline.
The COC will assume a supportive role within CO and work closely with the study team, CO leadership, vendors and external collaborators. The COC is responsible for coordinating and contributing to the progress of projects within HCW and initiated between HCW and external partners Duties and Responsibilities Coordinate the overall project tasks to ensure clinical trial deliverables are met on time and within scope. Facilitate the smooth initiation and execution of all clinical study operations under the direction of the department manager. Act as a liaison between the different trial stakeholders to ensure effective and consistent communication. Manages, maintains, and updates Electronic Data Capture (EDC) system. Manages, maintains, and updates Clinical Trial Management System (CTMS). Maintains inventory of clinical and laboratory supplies and coordinate shipments to sites as needed. Execute and track study drug shipment orders to clinical sites. Coordinate meetings with the site teams and take meeting minutes as needed. Manage trial-specific departmental activities, including study start-up and close-out, regulatory, contracts & budgets, and site payments under the oversight of the department manager. Coordinate internal resources and third parties/vendors for project execution. Coordinate multiple projects simultaneously and their respective project teams, complexities, and backgrounds through the entire project life cycle. Provide project updates and reports to various stakeholders to track performance against corporate goals and strategy. Study specific document writing, editing, and maintenance. Performs additional duties assigned to support overall departmental needs. Qualifications Minimum of 2 years of clinical research operations experience. Minimum of 1-2 years of project management experience. Undergraduate degree (or its international equivalent). Working knowledge of ICH, GCP, GDP, ALCOA, and local regulatory authority regulations preferred. Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. Effective team player, with experience working in cross-functional and global teams, but also able to work independently. Proven computer skills using Microsoft Office (including SharePoint, Teams, and Excel), Adobe, and Docusign preferred. Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity
Job Type:
Full-time Pay:
$50,000.00
00 per year
Benefits:
401(k) 401(k) matching Dental insurance Health insurance Health savings account Life insurance Paid time off Vision insurance
Work Location:
In person
