FSP - Sr. CRA 2 or CRA 2 - Oncology - North East US

Role Summary

The Senior CRA 2 is responsible for site monitoring and site management in oncology studies, ensuring implementation of project plans per Fortrea/Sponsor SOPs and regulatory guidelines. May function as a project lead for limited-scope projects and assume line management or Local Project Coordinator roles as assigned. Travel regionally with about 30% overnight.

Responsibilities

• Responsible for all aspects of study site monitoring including routine monitoring, 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 the study staff have received proper 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 by careful source document review of CRFs or other data collection tools.
  • Monitor data for missing or implausible data.
  • Manage travel expenses in an economical fashion according to SOPs and travel policy.
  • 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 plan development and trip report reviews as assigned.
• Review project progress and take actions to achieve target 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.
• Collaborate with internal teams to evaluate needs, resources, and timelines; act as contact for clinical trial supplies and vendors as assigned.
• Responsible for registry management as prescribed in project plans and undertake feasibility work when requested.
• Conduct, report, and follow-up on Quality Control visits when requested.
• Recruit investigators, prepare EC submissions, notify regulatory authorities, translate study documents, organize meetings, and other tasks as instructed by supervisor.
• Negotiate study budgets with investigators and assist with statements of agreements as assigned.
• Track and follow up on Serious Adverse Event (SAE) reporting and prepare related narratives and follow-up.
• Independently perform CRF review; generate and resolve data review queries as directed.
• Assist with training, mentoring, and development of new employees (e.g., co-monitoring).
• Coordinate designated clinical projects as Local Project Coordinator (with supervision, if applicable) and may act as local client contact as assigned.
• Perform other duties as assigned by management.

Qualifications

• Required: University or college degree (life science preferred), or certification in a related allied health profession; nursing certification or medical/laboratory technology background. In lieu of degree, minimum of 3 years relevant clinical research experience in pharmaceutical or CRO industries.
• Thorough knowledge of regulatory requirements and drug development process; fluent in local language and English (written and verbal).
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Experience: 4+ years of Clinical Monitoring experience for Sr. CRA 2 level, 2+ years for CRA 2 level; strong understanding of SAE reporting, data review, and monitoring principles; advanced site monitoring and registry administration skills; ability to work with minimal supervision; good planning, organization, and communication skills; ability to train and supervise junior staff; ability to work in a matrix environment; valid driver's license.

Preferred Qualifications

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

Additional Requirements

• Travel requirements: 30-40% overnight.