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Clinical Operations Associate

BB

Location
United States
Beacon Biosignals

Job Description

Beacon Biosignals is seeking a Clinical Operations Associate to oversee data collection and support activities in research projects where Beacon deploys its devices. This role is part of Beacon’s Clinical Operations team, a diverse set of talented, dedicated individuals with expertise across study startup, data monitoring, site support and study close-out, that manages clinical operations end-to-end. In this role, you'll work cross functionally to support Beacon's Life Sciences engagements with industry partners that power the development of novel therapies for patients with neurological, psychiatric, and sleep disorders. This role reports to the Director of Clinical Operations.
At Beacon, we've found that cultural and scientific impact is driven most by those who lead by example. As such, we're always seeking out new contributors whose work demonstrates innate curiosity, a bias toward simplicity, an eye for composability, a self-service mindset, and — most of all — a deep empathy toward colleagues, stakeholders, users, and patients. We believe a diverse team builds more robust systems and achieves higher impact.
Beacon's robust asynchronous work practices ensure a first-class remote work experience, but we also have in-person office hubs located in Boston, New York City, and Paris. For this position, candidates based in the eastern time zone of the United States are preferred to minimize logistical hurdles and maximize time zone overlap with colleagues and clients.

What success looks like:

  • Act as a daily point of contact for the sites / research teams; serve as the key communication link between the sites / research teams and Beacon
  • Maintain relationships with study site personnel to keep track of patient enrollment and data collection schedules
  • Ensure product is shipped, and track device usage for enrolled patients as determined with study team / Beacon management
  • Coordinate and manage the collection, compliance, delivery, entry, verification, analysis, and reporting of data
  • Exercise appropriate controls; monitor, and reconcile accounts
  • Handle support and complaints management activities in clinical trials where Beacon devices are deployed, with the support of Clinical Operations Managers and/or Director of Clinical Operations
  • Support training and operations of Beacon’s third party logistics provider(s)
  • Ensure that appropriate communication of issues and decisions related to device usage are escalated internally to the product team, as well as to CRO/sponsor or sites
  • Ensure the studies are always managed in accordance with GCP, SOPs and regulations

What you will bring:

  • 2+ years of experience working in clinical research, preferably in a coordinator role
  • Detail-oriented and meticulous in all aspects of workStrong communication skills
  • Must be proficient in Microsoft Office Word and Excel, electronic health systems and databases used in research environment, or have a willingness to learn and demonstrate proficiency within six months of hire
  • Knowledge using EDC systems (REDCap, Medidata Rave…) is desirable but not required
  • In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Ability to work within stipulated time frames or deadlines even in the face of multiple responsibilities or projects

Advice from our career coach

As a Clinical Operations Associate at Beacon Biosignals, your success will depend on your ability to manage data collection and support activities in various research projects. Here are some tips to help you stand out as a candidate:

  • Act as a daily point of contact for research teams to ensure clear communication with Beacon.
  • Maintain strong relationships with study site personnel to track patient enrollment and data collection schedules.
  • Coordinate and manage data collection, compliance, and reporting activities.
  • Exercise appropriate controls, monitor accounts, and handle support and complaints management.
  • Ensure studies are managed in compliance with GCP, SOPs, and regulations.
  • Have 2+ years of clinical research experience, preferably in a coordinator role.
  • Be detail-oriented, have strong communication skills, and be proficient in Microsoft Office and electronic health systems.
  • Knowledge of EDC systems like REDCap and Medidata Rave is desirable.
  • Demonstrate knowledge of Good Clinical Practice (GCP) and ICH guidelines.
  • Show ability to work within deadlines and manage multiple responsibilities effectively.

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About the job

Aug 27, 2024

Full-time

  1. US United States
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