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 for oncology studies. Responsible for clinical studies in accordance with Fortrea, Sponsor SOPs, and regulatory guidelines. Ensures implementation of project plans, acts as a leader for projects of limited scope, may assume line management responsibilities, and can serve as Local Project Coordinator or Lead CRA as assigned. Located in the North East US with regional travel required (approximately 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 study staff have received proper materials and instructions to safely enter patients into the study.
  • Ensure protection of study patients by verifying informed consent procedures and protocol requirements per regulatory requirements.
  • Ensure data integrity by careful source document review of CRFs or other data collection tools; monitor for missing or implausible data.
  • Efficiently perform monitoring tasks according to SOPs and guidelines, including managing travel expenses per Fortrea 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; serve as lead monitor for a protocol or project; assist in monitoring plan development and trip report review as assigned.
• Review project progress and take actions to achieve objectives; organize and present at Investigator Meetings.
• Participate in protocol and Case Report Form development; participate in writing clinical trial reports; coordinate with internal teams on needs, resources, and timelines.
• Act as contact for clinical trial supplies and other vendors; manage registry activities as prescribed in project plans; undertake feasibility work when requested.
• Conduct, report, and follow up on Quality Control visits; recruit investigators, prepare regulatory submissions, notify authorities, translate study documentation, and organize meetings as instructed.
• Negotiate study budgets with investigators and assist legal with statements of agreements; track and follow up on SAE reporting and narratives; perform CRF review and data queries as assigned.
• Assist with training and development of new employees; coordinate designated clinical projects as Local Project Coordinator (with supervision as applicable); may serve as local client contact.
• Perform other duties as assigned by management.

Qualifications

• Required: University or college degree (life science preferred), or certification in a related allied health profession; or nursing certification, medical or laboratory technology; or minimum of 3 years relevant clinical research experience in pharma/CRO industries.
• Required: Thorough knowledge of regulatory requirements and understanding of the drug development process; fluent in local language and English (written and verbal).
• Required: Ability to work with minimal supervision; strong planning, organizational, and computer skills; ability to train and supervise junior staff; ability to work in a matrix environment; valid driver's license.
• Preferred: One or more years of additional experience in related fields (medical, clinical, pharmaceutical, laboratory, research, data analysis, data management, or technical writing).
• Preferred: Local project coordination and/or project management experience.

Experience

• Minimum: 4+ years of Clinical Monitoring experience for Senior CRA 2 level; 2+ years for CRA 2 level.
• Understanding of SAE reporting and documentation; advanced site monitoring and site management skills; advanced registry administration skills.
• Demonstrated ability to work with minimal supervision, strong planning and organizational skills, and effective communication.
• Ability to train and supervise junior staff; ability to resolve project-related problems; ability to work within a project team; proficient in a range of computer packages.
• Valid Driver's License.

Physical Demands

• Travel requirements: 30-40%+ overnight.