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Senior Clinical Trial Associate

1 month, 3 weeks ago
Anywhere
Full-time
Senior
Project Coordinator
Project and Program Management
GCP
Apply Now
Definium Therapeutics

Definium Therapeutics

Definium Therapeutics is dedicated to advancing psychiatry by developing accessible treatments that leverage the therapeutic potential of psychedelic medicine, guided by scientific rigor and a commitment to addressing the root causes of mental health i...

Health Care Providers & Services
51-250
Founded 2019
View All Jobs 15

Description

  • Maintain and archive the Trial Master File in compliance with DIA Reference Model, SOPs, ICH, and GCP requirements.
  • Support study start-up activities, including budgets, contracts, financial disclosure statements, and grant payments.
  • Track and manage study documentation, including regulatory submissions, ethics committee approvals, and site contracts.
  • Develop and maintain spreadsheets, trackers, and other documents for study milestones, metrics, shipments, and discrepancies.
  • Prepare, review, and organize study materials such as reference manuals, clinical trial material requests, and Investigator Site Files.
  • Set up and coordinate meetings, take meeting notes, and distribute minutes and related communications.
  • Support the distribution of study communications, documents, supplies, and dosing room materials to sites and vendors.
  • Assist with vendor and site invoice tracking, accrual records, purchase order requests, and tax document collection.
  • Lead project-based assignments and sub-projects, including process documents, trackers, and Schedule I oversight activities.
  • Create process and guidance documents for Clinical Trial Assistant responsibilities and support SOP and systems development for tools such as CTMS and eTMF.
  • Provide mentorship, guidance, and daily oversight to junior Clinical Trial Assistants.
  • Serve as the administrative point of contact for third-party vendors and support general clinical team needs as assigned.

Requirements

  • Bachelor’s degree or equivalent combination of education and experience in a science- or health-related field.
  • Prior experience in clinical research, preferably as a Senior Clinical Trial Assistant or with at least 2 years as a Clinical Trial Assistant.
  • Experience in psychiatry and addiction medicine is preferred.
  • Working knowledge of GCP/ICH guidelines, the clinical development process, and drug development from pre-IND through NDA.
  • Prior experience developing tools and tracking documents that support clinical research.
  • Prior experience supporting study start-up activities.
  • Strong communication skills for working with outside vendors and contractors.
  • Strong working knowledge of MS Project or Smartsheet, including development of Gantt charts.
  • Advanced knowledge of MS Excel or Google Sheets.
  • Willingness and ability to travel 5-10% of the time and maintain flexible work hours during critical periods.
  • Excellent oral and written communication skills, problem-solving skills, strategic planning skills, and strong organizational skills.
  • Ability to work effectively in a fast-paced, dynamic environment with strong attention to detail.

Benefits

  • Starting base pay range of $91,943.00 to $112,330.00.
  • Eligibility for additional compensation, including bonus and equity.
  • 100% paid health benefits for medical, dental, and vision coverage for employees and dependents.
  • 401(k) program with company match and vesting after the first month after the start date.
  • Flexible time off.
  • Generous parental leave.
  • Additional fringe perks.

Interested in this position?

Apply directly on the company website

Apply Now

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