Description
The Senior CRA I is responsible for site monitoring and site management, ensuring clinical studies are conducted according to Fortrea and Sponsor Standard Operating Procedures and Regulatory Guidelines.
The Senior CRA I will implement project plans, lead 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 ensuring the protection of study patients
- Verifying informed consent procedures and protocol requirements are adhered to
- Ensuring data integrity and monitoring data for missing or implausible data
- Managing travel expenses and ensuring audit readiness at the site level
- Preparing accurate and timely trip reports
- Managing small projects and serving as lead monitor for a protocol or project
- Reviewing progress and initiating actions to achieve target objectives
- Organizing and making presentations at Investigator Meetings
- Participating in protocol development and writing clinical trial reports
- Interacting with internal work groups and acting as contact for clinical trial supplies and vendors
The Senior CRA I will also be responsible for:
- Registry management
- Feasibility work
- Conducting Quality Control visits
- Recruitment of potential investigators
- Negotiating study budgets
- Tracking and following up on Serious Adverse Event reporting
- Independently performing CRF review and query generation
- Assisting with training and mentoring new employees
Qualifications:
- University or college degree in life sciences or related field, or certification in a related allied health profession
- 3 years of clinical research experience in pharmaceutical or CRO industries
- Thorough knowledge of regulatory requirements and drug development process
- Fluent in local office language and English
Experience:
- 3 years of clinical monitoring experience
- Advanced site monitoring and study site management skills
- Ability to work with minimal supervision and good planning and organization skills
- Good computer skills and advanced verbal and written communication skills
- Ability to train and supervise junior staff
Physical Demands/Work Environment:
- Travel requirements: 60-80% overnight