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Clinical Research Coordinator

2 months ago

Waltham, Massachusetts, United States Beacon Hill Life Sciences - Boston Full time
Job Overview

Position Summary:

The Clinical Research Coordinator (CRC) role involves supporting the daily operations of clinical trials, including the management of documentation related to the execution of investigational studies. The CRC will collaborate with Clinical Trial Managers to facilitate various aspects of clinical trial management, including vendor interactions and the initiation and oversight of clinical studies. The ideal candidate will possess strong attention to detail and the ability to prioritize and manage multiple responsibilities in a dynamic organizational setting.

Key Duties and Responsibilities:

  • Establish and maintain tracking systems and tools to support the clinical study lifecycle from initiation to completion.
  • Assist in the creation and evaluation of clinical documents such as protocols, informed consent forms (ICFs), and study plans.
  • Organize and coordinate study meetings, prepare materials and agendas, and document and communicate decisions and action items.
  • Oversee and manage version control of clinical documents, effectively prioritizing multiple tasks and projects with minimal supervision.
  • Facilitate vendor engagement from the request for proposal (RFP) stage through to final contracting and purchase order setup.
  • Organize and manage SharePoint and central study files.
  • Coordinate training sessions for the assigned clinical study.
  • Manage laboratory sample tracking and provide vendor management support.
  • Assist in the coordination and monitoring of clinical supply shipments, including the review and approval of regulatory documentation packages.
  • Support the Clinical Operations team with various projects as needed.
  • Communicate effectively with study team members and collaborate closely to address challenges.

Minimum Qualifications:

  • Bachelor's degree or equivalent experience, with a minimum of one year in clinical operations within a sponsor organization; 1+ years preferred.
  • Understanding of drug development processes, clinical operations, and documentation, including study initiation, maintenance, and closure procedures.
  • Familiarity with Good Clinical Practice (GCP) and the Code of Federal Regulations as they pertain to clinical studies.
  • Experience with electronic Trial Master Files (eTMF) and the ability to apply essential document knowledge for filing.
  • Strong communication, organizational, and interpersonal skills.
  • Proficient in Microsoft Excel, Word, and PowerPoint; knowledge of MS Project and SharePoint is a plus.
  • Demonstrated ability to prioritize and manage multiple tasks simultaneously, identify and resolve issues, and effectively manage timelines.
  • Participation in inter-departmental workgroups to enhance processes.
  • Meticulous attention to detail and quality.
  • Excellent organizational and time management abilities.
  • Willingness to adapt to a flexible work environment.

Preferred Qualifications:

  • Experience with global studies utilizing an outsourced CRO model.
  • Background in clinical drug development, particularly with First in Human trials.
  • Knowledge of regulatory affairs, including IND/CTA submissions.
  • Experience in dermatology clinical trials.
Company Overview

Beacon Hill Life Sciences is committed to fostering a diverse workplace that values the unique contributions of every individual. We encourage applications from individuals with disabilities and protected veterans.

If you would like to complete our voluntary self-identification form, please follow the provided link. Participation in this process is voluntary and will not impact your employment opportunities or conditions. The information collected will be used solely for reporting purposes and will be kept confidential.