At a Glance
- Tasks: Monitor clinical study sites and ensure compliance with protocols while managing projects.
- Company: Join a leading clinical research organisation dedicated to advancing healthcare.
- Benefits: Competitive salary, travel opportunities, and professional development in a dynamic field.
- Other info: Opportunity for career growth and mentorship in a supportive environment.
- Why this job: Make a real difference in patient care through innovative clinical research.
- Qualifications: Degree in life sciences or relevant certification; 3+ years of clinical research experience.
The predicted salary is between 54000 - 66000 $ per year.
- Monitor and manage clinical study sites, including routine monitoring, closeout, pre-study, and initiation visits
- Maintain study files and liaise with vendors
- Ensure study staff receive materials and instructions to safely enroll patients
- Verify informed consent procedures and protocol compliance
- Review source documents and monitor data for missing or implausible information
- Ensure site-level audit readiness and prepare accurate, timely trip reports
- Manage small projects and serve as lead monitor for assigned protocols or projects
- Review project progress and initiate actions to achieve objectives
- Organize and present at Investigator Meetings
- Participate in protocol, Case Report Form, and clinical trial report development
- Coordinate clinical trial supplies and vendors
- Manage registry activities and undertake feasibility work
- Conduct, report, and follow up on Quality Control visits
- Recruit investigators and support ethics committee and regulatory submissions
- Negotiate study budgets and assist with agreements
- Track and follow up on Serious Adverse Event reporting
- Perform CRF review, query generation, and resolution in data management systems
- Train, mentor, and develop new employees
- Coordinate designated clinical projects as a Local Project Coordinator and act as local client contact when assigned
- Perform other duties assigned by management
Requirements
- University or college degree in life science preferred, or certification in a related allied health profession from an appropriately accredited institution
- Nursing certification, medical technology, or laboratory technology qualification accepted
- Minimum 3 years of relevant clinical research experience may substitute for the education requirement
- At least 3 years of clinical monitoring experience
- Thorough knowledge of regulatory requirements, including basic understanding of requirements in other countries
- Thorough understanding of the drug development process
- Fluent in the local office language and English, written and verbal
- Full understanding of Serious Adverse Event reporting, reports, narratives, and follow-up
- Advanced site monitoring skills
- Advanced study site management skills
- Advanced registry administration skills
- Ability to work with minimal supervision
- Good planning and organization skills
- Good computer skills and working knowledge of computer packages
- Advanced verbal and written communication skills
- Ability to train and supervise junior staff
- Ability to resolve project-related problems and prioritize workload for self and team
- Ability to work within a project team and effectively in a matrix environment
- Valid driver's license
- Ability to travel, including 60-80% overnight travel
- Core Competencies
Demonstrates advanced clinical monitoring and site management skills, with a thorough understanding of regulatory requirements and the drug development process.
Proficient in Serious Adverse Event reporting and capable of training and supervising junior staff while managing clinical study sites effectively.
- Highest-signal resume keywords
- Clinical Monitoring Experience
- Regulatory Requirements Knowledge
- Serious Adverse Event Reporting
- Advanced Site Management Skills
- Clinical Research Experience
- ATS Optimization Keywords Hard Skills
- Clinical Monitoring
- Site Management
- Registry Administration
- Data Management Systems
- Protocol Compliance
- Quality Control
- Feasibility Assessment
- CRF Review
- Project Coordination
- Budget Negotiation
- Soft Skills
- Planning and Organization
- Verbal and Written Communication
- Problem Resolution
- Team Collaboration
- Supervision and Training
Certifications & Qualifications
- Nursing Certification
- Medical Technology Qualification
- Laboratory Technology Qualification
- Industry Keywords
- Clinical Research
- Drug Development Process
- Informed Consent Procedures
- Investigator Meetings
- Ethics Committee Submissions
- Tools & Technologies
- Clinical Trial Management Systems
- Data Management Software
- Computer Packages
Senior Clinical Research Associate employer: Jobtailor
As a Network Engineer with us, you'll thrive in a dynamic work environment that prioritises innovation and collaboration. We offer competitive benefits, a strong focus on employee development, and opportunities to work with cutting-edge technologies while supporting Small and Medium Business clients. Our inclusive culture fosters growth and encourages proactive problem-solving, making it an ideal place for those seeking meaningful and rewarding employment.
We think you need these skills to ace Senior Clinical Research Associate
Communication Skills
Problem-Solving Skills
Time Management
Adaptability
Teamwork
Organizational Skills
Compassion
