Clinical Operations Associate

Job Locations US-MA-Bedford
ID
2021-1167
Category
Clinical Operations
Type
Full Time Salary

Overview

The Clinical Operations Associate will be responsible for assisting the study team in running the day to day operational activities of clinical studies.  The individual will be responsible for the coordination, tracking and management of daily activities for multiple clinical studies to support both the internal team and Clinical Research Organizations (CROs).  The company is focused on several gene therapy and gene editing developments, and each indication will be developed in clinical studies performed on a global scale in coordination with domestic and international CROs.  These studies will be submitted to health care regulatory authorities around the world such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). 

Responsibilities

  • Protocol review to ensure seamless integration between clinical objectives and study performance.
  • Works directly with Clinical Operations lead and/or Clinical Project Manager as well as internal and external medical experts to optimize and implement clinical studies.
  • Participate in CRO and study vendor review, selection, and negotiation
  • Supports interaction and maintains strong oversight of CROs in all aspects of study implementation and any study changes.
  • Participate in review of all supporting documents for a clinical study – Protocols, Informed Consent Forms, CRFs, Clinical Study Reports, etc.
  • Joint responsibility with clinical lead for monitoring the implementation and progress of a clinical study.
  • Develop and maintains relationships through regular interactions with CROs, vendors, investigators, monitors and other external partners while providing information and resolution for specific study requests and issues.
  • Supports the development and implementation of standard operating procedures and common work practices within the team.
  • Clinical study team member: Work closely with the cross-functional study team including the Clinical Operations team and is supports coordination, tracking, and management of logistics in support of clinical trials
  • Oversight of Trial Master File (TMF) to ensure ongoing completeness and accuracy is maintained
  • Tracks study status, enrollment, regulatory documentation, and site startup status for assigned clinical projects including review and approval of regulatory package for release of clinical supply.
  • Support reviews of clinical trial documentation including monitoring visit reports, monitoring plans, communication plans, country/site-specific Informed Consent Forms, etc.

Qualifications

  • Requires a BA/BS preferably in nursing, biology, biochemistry, or related areas.
  • 1-3 years experience in clinical operations, preferably supporting one or more clinical studies
  • Experience with early phase clinical research preferred (in sponsor or CRO setting)
  • Ensures adherence to standard operating procedures, good clinical practice, and FDA regulations with strong understanding of inspection readiness.
  • Fluent in Good Clinical Practice (GCP) and is able insure implementation within any clinical study.
  • Demonstrated knowledge and experience in the regulatory aspects of pharmaceutical development, including protocol implementation, data collection and reporting, and understands preparation of regulatory submissions including Investigational New Drug (IND) and New Drug Applications (NDA) specifically for FDA and EMA.
  • Demonstrated ability to work independently with exceptional organization and attention to detail.
  • Excellent oral and written communication and presentation skills.

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