Clinical Research Associate at GSK

Job Purpose
To ensure that clinical studies are conducted at investigator sites in compliance with;

• the current approved protocol and any protocol amendment(s),
• ICH GCP
• GSK Written Standards
• applicable local laws and regulatory requirement(s)

So that the rights, safety and well-being of human subjects is protected and that the reported study data is accurate, complete, and verifiable from source documents.

Essential Job Responsibilities

• Fully accountable for ALL aspects of site management including ensuring completion and delivery of all local activities required to ensure high quality set up, execution and completion of studies to agreed timelines and budget.
• Communicate progress and relevant study information or escalate issues of the study to the local study management team and other key stakeholders e.g. CRA Manager / Lead as appropriate.
• Accountable to acquire and maintain an optimal level of knowledge in all areas to effectively perform study activities.
• Build effective long-term collaborative relationships, and to uphold the reputation of GSK.

Knowledge/ Education / Previous Experience Required

Minimum Level of Education

• Scientific Degree or Equivalent Experience

Preferred Level of Education

• Masters of Science or equivalent. Advanced degree preferred but not essential

Area of Specialisation

• Any general science e.g. life science, medicine, clinical research, pharmacy etc.

Minimum Level Of Job-Related Experience Required

• 1- 3 years experience of clinical study monitoring or equivalent experience in the clinical research field is an asset
• Good English language written and verbal communication skills.
• Advanced/expert level of MS Office (PowerPoint, Excel, Word & Outlook)
• Has some level of technical expertise.

Other Job-Related Skills/Background

• Strong written and verbal communication skills in English and local language (if applicable), good presentation, negotiation and influencing skills.
• Able to work within teams and independently.
• Ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity.
• Good interpersonal skills.
• Strong planning & organizational skills, and the ability to work efficiently and effectively in a dynamic environment.
• Recognizes potential obstacles and works to resolve them within set timelines, takes responsibility for own actions.
• Respects confidentiality in terms of PII.
• Proactive, conscientious and precise in delivery of quality work even when under pressure
• Effective at analyzing and escalating issues, solving problems and resolving conflicts in a timely manner.
• Flexible with high learning and change agility
• Collaborative, building strong internal and external relationships.
• Knowledge of local regulations, IND/ICH GCP - guidelines, GSK written standards
• Available and willing to travel as job requires
• Strong computer skills with good eye for detail
• Acts as role model in line with GSK core values and behaviors