Clinical Trial Coordinator

Company: Association of Collegiate Conference and Events Di
Location: Cambridge
Posted on: April 6, 2021

Job Description:

Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum's proprietary product engine identifies drug targets which can modulate gene expression to treat the known root cause of gene mis-expression. The unique insights that we've gained from our approach have resulted in several new discovery programs that have emerged from FulcrumSeek, our proprietary connectivity map database and target identification platform, which are currently being prioritized and advanced. The company has advanced losmapimod to Phase 2 clinical development for the treatment of facioscapulohumeral muscular dystrophy (FSHD) and Phase 3 for the treatment of COVID-19. Fulcrum has also advanced FTX-6058, a small molecule designed to increase expression of fetal hemoglobin for the treatment of sickle cell disease and beta thalassemia into Phase 1 clinical development. Description We are seeking a highly motivated individual to join our team as a Clinical Trial Coordinator to maintain and co-ordinate the logistical aspects of clinical trials in compliance with Good Clinic Practice (GCP) and relevant Standard Operating Procedures (SOPs). This is a fantastic opportunity to join Fulcrum as a key member of the clinical operations team, supporting multiple clinical research studies that are aiming to patients without any other options. This individual will partner across the team and facilitate operational efficiencies in clinical trials, guided by SOPs and ICH-GCP. Requirements Responsibilities

• Assist with maintenance of the internal and external Trial Master Files (TMF); supports the cross-functional team with collection, filing, and tracking TMF documents.
• Support Clinical Operations team in conduct of study team meetings through drafting agendas, meeting minutes, and managing meeting logistics (meeting room, calendar invites).
• Assist in the planning and preparation for internal/external meetings (e.g. CRO Face-to-face meetings, investigator meetings, conferences).
• Review and track clinical trial regulatory documents in coordination with the CRO.
• Assist the Clinical Operations team with oversight of study team roster maintenance and vendor contact lists.
• Actively participate and contribute ideas in the development of department initiatives and goals.
• Source and distribute study supplies.
• Maintain study tracking tools and study calendars.
• Assist with tracking vendor invoices and internal approvals.
• Assist the Clinical Operations team with preparing and reviewing documentation (e.g. study manuals and plans) for assigned trials.
• Assist the Clinical Operations team with preparing study updates for internal and external stakeholders.
• Balance competing and evolving priorities across trials.
• Collaborate closely with the Clinical Operations team, cross-functional study teams (internal/external) and CRO partners to support the execution of clinical studies.
• Other duties as assigned Qualifications
  • BS / MS or equivalent
  • 2-3 years' experience in clinical research at a hospital, CRO, or biopharmaceutical company is desirable
  • Superior understanding of Microsoft Office
  • Capacity to complete tasks independently in a highly regulated environment
  • Flexibility to function well within a team environment and within condensed timelines
  • Excellent written and verbal communication skills
  • Strong interpersonal skills
  • Basic understanding of learn FDA regulatory requirements and good clinical practice (GCP) Job Information
    • Job ID: 55333775
    • Location:
      Cambridge, Massachusetts, United States
    • Position Title: Clinical Trial Coordinator Fulcrum Therapeutics is focused developing new medicines to deliver a new future for patients and their families by transforming gene regulation in disease. The Fulcrum product engine is based on the breakthrough biology of gene regulation. It will bring to bear medicines for devastating diseases across multiple therapeutic areas by modulating - or balancing - the expression of the genes known to drive disease. The Fulcrum product engine integrates insights from four scientific disciplines: Gene Regulation, Human Genetics a... Senior Operations Coordinator, Technical...

Keywords: Association of Collegiate Conference and Events Di, Cambridge , Clinical Trial Coordinator, Healthcare , Cambridge, Massachusetts