Clinical Research Associate II, Medical Device - Boston, East Coast & Central US

Role Summary

The Clinical Research Associate II (Medical Device) will be responsible for site monitoring and site management of clinical studies in accordance with Fortrea, sponsor SOPs, and regulatory guidelines. The role may involve leading projects of limited scope, line management responsibilities, and acting as Local Project Coordinator or Lead CRA as assigned. This position is based in the Boston area, the East Coast, or Central US.

Responsibilities

• Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties as assigned.
• Responsible for all aspects of site management as prescribed in the project plans.
• General On-Site Monitoring Responsibilities:
  • Ensure study staff have materials and instructions to safely enter patients into the study.
  • Ensure patient protection by verifying informed consent procedures and protocol requirements are adhered to per regulatory requirements.
  • Ensure data integrity on CRFs/other data collection tools by source document review.
  • Monitor data for missing or implausible data.
  • Manage travel and monitoring tasks efficiently according to SOPs and travel policy; oversee travel expenses.
  • Ensure audit readiness at the site level.
  • Travel, including air travel, may be required and is an essential function of the job.
  • Prepare accurate and timely trip reports.
  • Manage small projects under the direction of a Project Manager/Director as assigned.
  • Serve as lead monitor for a protocol or project and assist in monitoring plans and trip report review as assigned.
  • Review project progress and initiate actions to achieve objectives.
  • Organize and present at Investigator Meetings.
  • Participate in protocol and Case Report Form development as assigned.
  • Participate in writing clinical trial reports as assigned.
  • Interact with internal teams to evaluate needs, resources, and timelines.
  • Act as contact for clinical trial supplies and other vendors as assigned.
  • Responsible for all aspects of registry management as prescribed in project plans.
  • Undertake feasibility work when requested.
  • Conduct, report, and follow-up on QC visits when requested.
  • Recruit potential investigators, prepare EC submissions, regulatory notifications, translate study documents, organize meetings, and other tasks as assigned.
  • Negotiate study budgets with investigators and assist legal with statements of agreements as assigned.
  • Track and follow-up on Serious Adverse Event (SAE) reporting, including report production, narratives, and follow-up.
  • Independently perform CRF review; generate and resolve queries against data review guidelines.
  • Assist with training, mentoring, and development of new employees (e.g., co-monitoring).
  • Coordinate designated clinical projects as a Local Project Coordinator (with supervision if applicable), and may act as local client contact as assigned.
  • Perform other duties as assigned by management.

Qualifications

• University or college degree (life science preferred), or certification in a related allied health profession; nursing certification, medical or laboratory technology accepted. In lieu of education, at least 3 years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.
• Thorough knowledge of regulatory requirements, including basic understanding of regulatory requirements in other countries.
• Thorough understanding of the drug development process.
• Fluent in local office language and in English, both written and verbal.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience

• One year of Clinical Monitoring experience.
• Strong understanding of SAE reporting and follow-up processes.
• Advanced site monitoring, study site management, and registry administration skills.
• Ability to work with minimal supervision and strong planning/organizational skills.
• Proficient computer skills and experience with data management systems.
• Excellent verbal and written communication skills; ability to train and supervise junior staff.
• Ability to resolve project-related problems and prioritize workload; works well in a matrix environment.
• Valid Driver's License.

Preferred Qualifications

• One or more additional years of experience in a related field (medical, clinical, pharmaceutical, laboratory, research, data analysis, data management, or technical writing).
• Local project coordination and/or project management experience.

Physical Demands / Work Environment

• Travel requirements: 60-80% overnight.
• Work is performed in an office environment with exposure to electrical equipment; frequent travel to client/site locations, with possible domestic and international travel.
• Physical requirements include sitting for extended periods, repetitive hand movements, bending/twisting, ability to lift up to 15-20 lbs, and ability to operate a vehicle safely.
• Varied hours may be required.