Description
We are seeking a Senior Clinical Research Associate II (Sr CRA II) to join our team. As a Sr CRA II, you will be responsible for site monitoring and site management for clinical studies according to Fortrea and/or Sponsor Standard Operating Procedures and Regulatory Guidelines.
Responsibilities:
- Conduct site monitoring and site management for clinical studies
- Ensure implementation of project plans and function as leader for projects of limited scope
- Manage study site monitoring, including routine monitoring and close-out of clinical sites
- Maintain study files and conduct pre-study and initiation visits
- Liaise with vendors and perform other duties as assigned
- Ensure study staff have received proper materials and instructions to safely enter patients into the study
- Verify informed consent procedures and protocol requirements are adhered to
- Monitor data for missing or implausible data
- Ensure audit readiness at the site level
- Travel may be required, including air travel
- 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
- Review progress of projects and initiate actions to achieve target objectives
- Organize and make presentations at Investigator Meetings
- Participate in development of protocols and Case Report Forms
- Participate in writing clinical trial reports
- Interact with internal work groups to evaluate needs, resources, and timelines
- Act as contact for clinical trial supplies and other suppliers
- Responsible for registry management
- Undertake feasibility work and conduct Quality Control visits
- Recruit potential investigators and prepare EC submissions
- Negotiate study budgets with potential investigators
- Track and follow-up on Serious Adverse Event (SAE) reporting
- Independently perform CRF review and query generation and resolution
- Assist with training and mentoring of new employees
- Coordinate designated clinical projects as a Local Project Coordinator
Qualifications:
- University or college degree in a related allied health profession
- Certification in a related allied health profession (e.g., nursing licensure)
- Equivalent amount of experience can be substituted as appropriate
- Thorough knowledge of regulatory requirements and drug development process
- Fluent in local office language and in English, both written and verbal
- Three-Four years of Clinical Monitoring experience
- Advanced site monitoring skills, study site management skills, and registry administration skills
- Ability to work with minimal supervision and good planning and organization skills
- Good computer skills with good working knowledge of a range of computer packages
- Advanced verbal and written communication skills
- Ability to train and supervise junior staff
Preferred Qualifications:
- Thorough knowledge of company SOPs regarding site monitoring
- Experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management, or technical writing)
- Local project coordination and/or project management experience
- Ability to maintain confidentiality of data and information
- Demonstrated ability to conduct clinical operations activities effectively and efficiently
- Methodical approach to work and strong understanding of medical and clinical research terminology