Site Name: China - Shanghai - PuDong New District - Lane 999 Huanke Road - Building18 Posted Date: Nov 1 2024 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. In addition to the monitoring duties of a CRA, the Senior CRA will demonstrate the ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity. Provide training and monitoring support for new and less experienced CRAs as and when required. Ensures competency of less experienced CRAs by participating in joint site visits or co-monitoring visits. Take a leadership role in standardizing processes within and across LOCs, identifying and sharing best practices and continuous improvement. Provide leadership in resolving complex monitoring issues through discussion with other CRAs, local study management and other GSK departments as appropriate. Job purpose and key responsibilities: Responsible to contribute to the wider business by taking on leadership roles representing monitoring interests on internal and cross functional process improvement teams, standardizing processes, identifying and sharing best practices and continuous improvement. Act as a role model, coach, mentor for new or less experienced CRAs on processes, study, technical and behavioural competencies including resolving difficult situations. 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. At 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. Communicate progress and relevant study information or escalate issues of the study to the local study delivery lead 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. 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. 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. 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. 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. 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. 3+ years’ experience in clinical research (monitoring) required, with experience in all stages of study lifecycle (start-up, recruitment and close out). Given the nature of the job and the coaching/mentoring role, a minimum experience of 3 year in the domain is required as well as a profound operational knowledge of clinical research. 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 organisation 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: Advanced degree preferred but not essential. Any general science e.g. life science, medicine, clinical research, pharmacy etc. These roles interface directly with external physician and other clinical site staff and must be able to convey GSK positions and requirements to a highly educated external partner group. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. 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