Description
The Senior CRA I is responsible for site monitoring and site management. You will be responsible for clinical studies according to Fortrea and/or Sponsor Standard Operating Procedures and Regulatory Guidelines.
You will assure the implementation of project plans, as assigned, and function as leader for projects of limited scope. You may also assume line management responsibilities and act in the project role of a Local Project Coordinator or Lead CRA.
Responsibilities:
- Conduct site monitoring, including routine monitoring and closeout of clinical sites, maintenance of study files, and 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 according to regulatory requirements
- Review source documents to ensure data integrity
- Monitor data for missing or implausible data
- Manage travel expenses in an economical fashion according to Fortrea's travel policy
- 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
- Participate in protocol development and 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
- Undertake feasibility work and conduct Quality Control visits
- Recruit potential investigators, prepare EC submissions, and notify regulatory authorities
- Negotiate study budgets with potential investigators
- Track and follow-up on Serious Adverse Event reporting
- Independently perform CRF review and query generation
- Assist with training and mentoring new employees
- Coordinate designated clinical projects as a Local Project Coordinator
Qualifications:
- University or college degree in life sciences or related field, or certification in a related allied health profession
- 3 years of relevant 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, study site management, and registry administration skills
- Ability to work with minimal supervision and good planning and organisation 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