Clinical Trial Operations Professional

4 weeks ago


Waltham, Massachusetts, United States Beacon Hill Life Sciences - Boston Full time
About the Role

We are seeking a highly skilled Clinical Trial Associate to join our team at Beacon Hill Life Sciences in Boston. This is a fantastic opportunity to work in a dynamic and growing company environment where you will be responsible for assisting with daily clinical trial execution activities, including the coordination of documents associated with the conduct of investigational clinical studies.

Key Responsibilities:

  • Develop and maintain tracking systems and set up tools to support the conduct of a clinical study from start-up to close-out, ensuring seamless coordination and efficient execution.
  • Collaborate with Clinical Trial Managers to develop and review clinical documents, including protocols, ICFs, and clinical study plans, ensuring compliance with regulatory requirements.
  • Schedule and coordinate study meetings, materials, and agendas, recording and disseminating decisions and actions to ensure effective communication and project progress.
  • Manage and prioritize multiple tasks and/or projects with limited supervision, utilizing strong organizational and time management skills to meet deadlines and deliver high-quality results.
  • Facilitate vendor engagement, from RFP distribution to final contracting and PO setup, ensuring smooth interactions and contract management.
  • Set up and organize Sharepoint and central study files, maintaining accurate and up-to-date documentation and records.
  • Coordinate training for assigned clinical studies, ensuring effective knowledge transfer and compliance with regulatory requirements.
  • Manage study laboratory sample tracking and vendor management support, ensuring efficient and accurate sample management.
  • Assist in coordinating and tracking clinical supply shipments, including review and approval of Regulatory Documentation Packages, ensuring compliance with regulatory requirements.
  • Support the Clinical Operations team with specific projects, utilizing expertise and knowledge to drive project success.
  • Effectively communicate with study team members, work closely to address challenges, and provide solutions to ensure project success.

What We Offer:

  • A competitive estimated salary range of $65,000 - $85,000 per year, based on experience and qualifications.
  • A dynamic and growing company environment with opportunities for professional growth and development.
  • A collaborative and supportive team culture that values diversity, equity, and inclusion.

Requirements:

  • BS/BA degree or equivalent and at least one year of experience in clinical operations in a Sponsor company, with 1+ years strongly preferred.
  • Knowledge of drug development, clinical operation processes, and documentation, including study start-up procedures, maintenance phase, and study close-out procedures.
  • Experience with eTMF and ability to directly apply essential document knowledge to file documents.
  • Effective communication, organizational, and interpersonal/team skills, with proficiency in MS Excel, Word, and PowerPoint.
  • Established ability to prioritize and manage multiple tasks simultaneously, with demonstrated ability to identify and resolve issues, and effectively manage timelines.

Preferred Qualifications:

  • Experience with global studies, using an outsourced CRO model.
  • Experience in clinical drug development with knowledge of First in Human trials.
  • Experience with regulatory affairs, including IND/CTA submissions.
  • Experience working on dermatology.

About Beacon Hill Life Sciences:

Beacon Hill Life Sciences is an Equal Opportunity Employer that values the strength diversity brings to the workplace. We encourage individuals with Disabilities and Protected Veterans to apply.
Completion of our voluntary self-identification form is optional and will not affect your opportunity for employment or the terms and conditions of your employment.



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