Clinical Trial Associate

4 weeks ago

Bedford, United States Delix Therapeutics Full time

The Company

Delix Therapeutics is a neuroscience company focused on harnessing the power of psychoplastogens—novel neuroplasticity-promoting therapeutics—to treat brain health disorders. Delix is advancing these compounds through preclinical and clinical development to bring patients FDA-approved medicines that will address significant unmet needs. Headquartered in Massachusetts, Delix is building a world-class biotechnology company by combining an experienced team with innovative treatment strategies and scientific rigor to address the significant and growing brain health challenges impacting society.

The Position

This is an exciting opportunity for a Clinical Trial Associate who is interested in providing operational support for ongoing and future clinical studies at Delix Therapeutics. This position will work closely with the Head of Clinical Operations and Project Management to ensure key deliverables are met for each of the studies. This is an opportunity to work across multiple phases of development on global studies and have a direct impact in helping Delix achieve important corporate milestones.

The ideal candidate is a self-starter with a positive attitude who can adapt quickly.

Essential Responsibilities and Duties

  • Supports the Head of Clinical Operations and Program Management in the planning and coordination of all aspects of clinical trial operations
  • Provide project management and operational support to the clinical project team, ensuring that quality, timelines, and project specifications are met
  • Manage study documentation ensuring accuracy within the documentation while aiding in the preparation of supply shipments to study sites
  • Setup, maintain, and update databases and assist with data query resolution
  • Perform quality control checks to ensure the integrity of data
  • Communicate with study sites
  • Manage internal process for approval of contracts, purchase orders and invoices
  • Assist in the development of study documents, including study and lab manuals
  • Supports study management team with organizing clinical team meetings by taking comprehensive meeting minutes and follow-up on action items
  • Assist with accurately updating and maintaining clinical documents and systems that track study documents, site compliance, and performance within project timelines
  • Assist with the preparation, handling, distribution and filing of clinical documents
  • Participates in study start-up document collection
  • Support study site and vendor invoice management
  • Ensure study compliance with Delix’s SOPs and regulatory guidelines by performing periodic quality control audits of the electronic trial master file (eTMF) throughout all study phases including study initiation, implementation, and closure
  • Maintain current knowledge of applicable US and international clinical regulations, standards, and guidance documents
  • Monitor drug and ancillary supplies and place orders with the central depot to ensure adequate stock at sites
  • Consolidate dosing data from electronic source to ensure patient dosing compliance
  • Monitor clinical trial Insurance and license agreements across studies and work with vendors to ensure current agreements
  • Facilitate shipment of various samples defined in the protocols to third party labs
  • Manage Clinicaltrials.gov postings
  • Manage translations of study documents
  • Develop and maintain internal and external trackers

Minimum Requirements

  • BA/BS in life sciences or related area
  • 1-2+ years relevant experience in a pharmaceutical/biotechnology or CRO environment, or hospital setting
  • Knowledge and training on GCP
  • Strong computer skills in Microsoft Office: Outlook, Word, Excel, PowerPoint required, MS Project experience preferred
  • Excellent problem solving, organizational, interpersonal, and communication skills
  • Strong time management, problem-solving, and organizational skills
  • Ability to adjust to shifting priorities and meet timelines
  • Detail oriented, flexible, and works well within a team environment
  • Limited travel to support site feasibility/assessment, and potentially oversight of CRO monitoring may be required.


Delix is an equal opportunity employer committed to a diverse and inclusive work environment.

Recruitment and Staffing Agencies: Delix Therapeutics does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Delix or its employees is prohibited unless contacted directly by Delix Talent Acquisition Team.

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