Description
The Senior CRA I is responsible for site monitoring and site management of clinical studies according to Fortrea and/or Sponsor Standard Operating Procedures and Regulatory Guidelines.
The Senior CRA I will assure the implementation of project plans, act as a leader for projects of limited scope, and assume line management responsibilities as assigned.
Key responsibilities include:
- Conducting site monitoring, including routine monitoring and closeout of clinical sites
- Maintaining study files and conducting pre-study and initiation visits
- Liaising with vendors and other stakeholders
- Ensuring the protection of study patients and the integrity of data submitted
- Monitoring data for missing or implausible entries
- Managing travel expenses and ensuring audit readiness at the site level
- Preparing accurate and timely trip reports
- Managing small projects and serving as a lead monitor for a protocol or project
- Reviewing progress of projects and initiating actions to achieve target objectives
- Organizing and making presentations at Investigator Meetings
- Participating in the development of protocols and Case Report Forms
- Interacting with internal work groups to evaluate needs, resources, and timelines
- Acting as a contact for clinical trial supplies and other suppliers
- Undertaking feasibility work and conducting Quality Control visits
- Recruiting potential investigators and preparing EC submissions
- Negotiating study budgets with potential investigators
- Tracking and following up on Serious Adverse Event reporting
- Independently performing CRF review and query generation and resolution
- Assisting with training and mentoring of new employees
The ideal candidate will have:
- A university or college degree in life sciences or a related field
- At least 3 years of clinical research experience in the pharmaceutical or CRO industries
- Thorough knowledge of regulatory requirements and the drug development process
- Fluent English and local office language skills
- Advanced site monitoring, study site management, and registry administration skills
- Ability to work with minimal supervision and prioritize workload
- Good planning and organization skills, computer skills, and verbal and written communication skills
- Valid Driver's License
Preferred qualifications include:
- Additional experience in a related field
- Local project coordination and/or project management experience
The physical demands of the job include:
- 60-80% overnight travel requirements