Clinical Research Associate II, Medical Device - West Coast or Midwest

Role Summary

Clinical Research Associate II, Medical Device - West Coast or Midwest. The CRA 2 is responsible for site monitoring and site management for clinical studies conducted under Fortrea or Sponsor SOPs and regulatory guidelines. May serve as lead monitor or Local Project Coordinator on 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 staff have proper materials and instructions to enter patients into the study; protect study patients by verifying informed consent and protocol adherence; ensure data integrity through source document review; monitor data for missing or implausible data.
• Manage travel expenses in an economical fashion according to Fortrea 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; serve as lead monitor for a protocol or project; assist in establishing monitoring plans and trip report review as assigned.
• Review progress of projects and initiate appropriate actions to achieve target objectives; organize and present at Investigator Meetings.
• Participate in the development of protocols and Case Report Forms 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 the 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, translation of study docs, 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 reporting, production of reports and narratives, and follow-up of SAEs.
• Independently perform CRF review; query generation and resolution against data review guidelines; assist with training and development of new employees.
• Coordinate designated clinical projects as a Local Project Coordinator and may act as a local client contact as assigned.
• Perform other duties as assigned by management.

Qualifications

• Minimum: University or college degree (life science preferred), or related allied health certification; or minimum of 3 years relevant clinical research experience in pharma or CRO industries.
• Thorough knowledge of regulatory requirements and the drug development process; fluent in local language and English (written and verbal).
• Fortrea may consider relevant equivalent experience in lieu of education.

Experience

• Minimum 1 year of Clinical Monitoring experience.
• Understanding of SAE reporting and follow-up; advanced site monitoring and registry administration skills.
• Ability to work with minimal supervision; strong planning, organizational, and communication skills.
• Ability to train and supervise junior staff; ability to work in a matrix environment.
• Valid Driver's License.

Preferred Qualifications

• Additional year(s) of experience in related fields (medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
• 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, including domestic and international travel.
• Physical requirements include sitting for extended periods, repetitive hand movements, occasional crouching/stooping, bending/ twisting, light to moderate lifting (up to 15-20 lbs).