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

Role Summary

Clinical Research Associate II, Medical Device – Boston, East Coast & Central US. The CRA 2 is responsible for site monitoring and site management across clinical studies in accordance with Fortrea, Sponsor SOPs, and Regulatory Guidelines. May act as Local Project Coordinator or Lead CRA as assigned, and may assume line management responsibilities for projects of limited scope.

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 the study staff have received the proper materials and instructions to safely enter patients into the study.
  • Ensure the protection of study patients by verifying informed consent procedures and protocol requirements adhere to regulatory requirements.
  • Ensure the integrity of data submitted on Case Report Forms or other data collection tools by careful source document review.
  • Monitor data for missing or implausible data.
  • Ensure efficient use of Sponsor and Fortrea resources, including managing travel expenses according to 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 and trip report review as assigned.
• Review progress of projects and initiate actions to achieve target objectives.
• Organize and present at Investigator Meetings.
• Participate in protocol and Case Report Form development as assigned; contribute to writing clinical trial reports.
• Interact with internal groups to evaluate needs, resources, and timelines.
• Act as contact for clinical trial supplies and other suppliers (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 Quality Control visits when requested.
• Recruit investigators, prepare EC submissions, regulatory notifications, translate study documentation, organize meetings, and other tasks as instructed.
• Negotiate study budgets with investigators and assist with statements of agreements as assigned.
• Track and follow-up on SAE reporting, produce reports, narratives and follow up of SAEs.
• Independently perform CRF review; query generation and resolution per guidelines on Fortrea or client data management systems.
• 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 a local client contact as assigned.
• Perform other duties as assigned by management.

Qualifications

• University or college degree (life science preferred) or related allied health certification; nursing certification or medical/lab technology degree acceptable. Alternatively, minimum of 3 years relevant clinical research experience.
• Thorough knowledge of regulatory requirements and the drug development process; fluent in local language and English.
• Fortrea may consider relevant equivalent experience in lieu of educational requirements.

Experience

• One year of Clinical Monitoring experience.
• Knowledge of SAE reporting and data review processes; advanced site monitoring, site management, and registry administration skills.
• Ability to work with minimal supervision; strong planning, organization, and communication skills.
• Ability to train and supervise junior staff; ability to resolve project-related problems; works well in a matrix team environment.
• Valid Driver's License.

Preferred Qualifications

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

Physical Demands / Work Environment

• Travel requirements: 60-80% overnight.
• Office environment with travel to client/site locations; potential domestic and international travel.
• Physical ability to sit for extended periods, operate a vehicle safely, and lift/light carrying up to 15-20 lbs; regular attendance and varied hours may be required.