This individual will 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.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

• Accountable for all aspects of site management including ensuring completion and delivery of all local activities required for high quality set up, execution and completion of studies to agreed timelines. 
• Performs operational site evaluation visits, study initiation visits, on and off site monitoring visits at the required frequency (Risk Based Monitoring) and site closeout visits. 
• Collaborates with the study teams to conduct study feasibility and site selection. Performs site evaluation visits, determines the feasibility of conducting protocols with reference to study complexity, staff availability, clinical facilities, potential for recruiting patients, site selection and ability to comply with ICH GCP investigator and GSK requirements for clinical studies.  
• Works with Local Delivery Lead (LDL) to carry out a local study / site level risk assessment. Assists with audits and inspections. 
• 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.  
•  Ensure that critical study timelines related to monitoring activities are achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related milestones are met.  
• Maintain good relationships with site while communicating and implementing patient inclusion / exclusion criteria, study stop/go decisions, timeline changes, early termination of studies and changed status of studies. 
• Work with the sites to ensure they address data queries in a timely manner. Ensure Investigator and site staff receives safety reports and new safety information in a timely manner. 
• Assist (depending on local practices) with submission of Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs) and maintain communication with RA and ECs to ensure all regulatory requirements are met in timely manner throughout the study. 
• Ensure all necessary study supplies are available at sites in a timely manner and appropriate accountability is maintained during the study. Ensure all unused study supplies are accounted for and destroyed appropriately. 
• Ensure clinical study activities are conducted in accordance with the clinical trial agreement and related contracts. 
• Responsible for maintaining the sponsor files during the life of the study. Assisting with archiving at the end of study in accordance with relevant GSK SOPs, policies and local regulatory requirements.  
• Delivers appropriate training to site staff and other relevant parties, as required.  
• Accountable to acquire and maintain an optimal level of knowledge in all areas to effectively perform study activities. May take on role of local expert/champion or subject matter expert in a business system / process. 
• Share best practices within the LOC and with colleagues in other LOCs. 
• Acquire and maintain an appropriate level of knowledge on the pathology of disease area being studied, the study compound, the study protocol and all study related activities. 
• Attendance at internal project meetings and relevant training courses. Participate continuously in relevant training courses to improve personal / professional skills. Keep up to date with all the changes / required knowledge on ICH GCP, GSK written standards and attending appropriate training sessions. 
• Available and willing to travel as job requires. 
   

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Scientific Degree or equivalent experience. Any general science e.g. life science, medicine, clinical research, pharmacy etc. This role requires a good understanding of scientific and medical information and an ability to apply this understanding to the conduct of clinical research activities.
• 1- 3 years experience of clinical study monitoring or equivalent experience in the clinical research field is an asset. Knowledge of local regulations, IND/ICH GCP - guidelines, GSK written standards.
• Good English and local language written and verbal communication skills, given the interactions with GSK R&D staff, centrally or LOC based.
• Able to work within teams and independently. Ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity.
• Good collaboration and organization skills with ability to interact well with all levels of management and staff. Internally, interactions with relevant functions from the Regional and Central team. Externally, communicate and work effectively with medical staff/physicians/scientists who are often senior within their field, being mindful of their standing within the medical and/or research community).

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Advanced degree preferred but not essential. Any general science e.g. life science, medicine, clinical research, pharmacy etc. These roles interface directly with external physicians and other clinical site staff and must be able to convey GSK positions and requirements to a highly educated external partner group.

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Ability to work in an environment that is constantly evolving with new processes and systems, internally and externally. The CRA needs to be able to adapt to these changes quickly and efficiently.
• A variety of problems (simple and highly complex) can occur during a clinical study. Problems or mistakes at investigational sites are identified by CRA during the monitoring visits for a study and needs to be resolved quickly and effectively in line with strict regulations regarding clinical studies.
• Proactive, conscientious and precise in delivery of quality work even when under pressure. Flexible with high learning and change agility.
• Collaborative, building strong internal and external relationships.
• Strong planning & organizational skills, and the ability to work efficiently and effectively in a dynamic environment

*This is a job description to aide in the job posting, but does not include all job evaluation details.

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