Study Operations Associate (Level Based on Experience)

Cambridge, UK | Full Time | Clinical Operations

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Job Description

Job Summary

Primarily responsible for in-house study and site management.  Activities include: assisting with study start up, enrollment, tracking study metrics, site management, vendor management, and Sponsor Oversight Visits, as requested.  Works with Study Team (CRAs, CPMs, and Medical Monitors) to ensure successful planning, execution, and completion of clinical trials within expected timelines.

 

Job Responsibilities

  • Support the Clinical Operations Manager with various aspects of a trial execution to ensure that studies are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
  • Assist with key study parameters (e.g. start-up activities, enrollment, site management, data collection, data reviews, site feasibility, database lock, etc.) and proactively identify solutions within the clinical team when issues arise
  • Develop and review informed consent forms, case report forms, study manuals, and other study operations material
  • Assist with evaluating, selecting, and managing clinical study sites
  • Assist in the evaluation of CROs, other vendors, and systems.  Negotiate contracts/budgets with CROs and other vendors as applicable
  • Track/maintain study metrics/progress and providing routine study updates to the project team/sub-team
  • Develop/review action plans to address issues with investigational sites and/or CROs/vendors
  • Assist with creation of study specific tools and manuals to ensure timeliness, standardization and control of data quality
  • Serve as a primary contact for sites
  • Review and provide input on regulatory documents and Clinical Trial Application documents
  • Review and negotiate clinical site study contracts and budgets
  • Assist, coordinate, and present at Investigator Meetings and CRA Training meetings as requested
  • Perform Sponsor Oversight Visits as required/requested
  • Support internal and regulatory audits of clinical trial sites and vendors and assist with resolution of audit findings
  • Coordinate/participate in clinical team meetings/teleconference/WebEx and prepares agendas, meeting minutes, and track action items
  • Identify and escalate issues appropriately
  • Ensure timely entry and updates to ‘Clinicaltrial.gov’ on an ongoing basis
  • Manage internal trial master files
  • Create/revise/review departmental SOPs, as requested
  • Performs other work-related duties as assigned

     

Skills & Requirements

Qualifications

  • Knowledge of FDA regulatory requirements and ICH/GCP guidelines
  • Demonstrated proficiency in supporting the operational activities of a clinical trial, from start-up to close-out. Experience with working on global trials a plus
  • Strong organizational skills, ability to prioritize and multi-task
  • Excellent verbal and written communication skills
  • Demonstrated problem-solving and negotiation abilities
  • Ability to work as part of a team/active team participant
  • Computer proficiency (Outlook, MS Word, Excel, and PowerPoint)

Education and Experience

  • Bachelor’s degree in a scientific discipline or health-related field
  • Years clinical research experience (Site coordinator, site Monitor, in-house CRA) required will vary depending on level
  • Previous experience with Global oncology clinical trials is strongly preferred

Working Conditions

  • Willingness to travel as necessary, consistent with project needs