Join Thermo Fisher Scientific and make a positive global impact. Our mission is to enable customers to improve health outcomes worldwide. We provide resources to help you achieve your career goals while advancing life-changing therapies through research and development. With our PPD clinical research portfolio, we conduct clinical trials in 100+ countries and innovate in laboratory, digital, and decentralized clinical trial services.

At PPD® clinical research services, our Clinical Operations colleagues provide end-to-end assistance for clinical trials on a global scale. We handle study start-up, monitoring, and study closeout, working on both commercial and government contracts. Our focus is to collaborate with clients in defining and advancing clinical programs, minimizing delays, and ensuring the delivery of high-quality and cost-efficient clinical studies.

Key Responsibilities

• 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.  

• Communicates 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.  

• Ensures 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.  

• Maintains 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.  

• Works with the sites to ensure they address data queries in a timely manner. Ensure Investigator and site staff receive safety reports and new safety information in a timely manner.  

• Assists (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.  

• Ensures 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.  

• Ensures 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.  

• Shares best practices within the LOC and with colleagues in other LOCs.  

• Acquires and maintains 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. Participates continuously in relevant training courses to improve personal / professional skills. Keeps 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. 

Qualifications

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor).

• Bachelor's degree or equivalent experience in a life sciences related field or a Registered Nursing certification.

• Effective clinical monitoring skills.

• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.

• Excellent understanding and demonstrated application of ICH GCPs, applicable regulations, and procedural documents.

• Well-developed critical thinking skills.

• Ability to manage Risk Based Monitoring concepts and processes.

• Effective oral and written communication skills.

• Ability to maintain customer focus through good listening skills and attention to detail.

• Effective interpersonal skills.

• Strong attention to detail.

• Effective organizational and time management skills.

• Flexibility and adaptability in a wide range of scenarios.

• Ability to work in a team or independently as required.

• Good computer skills: proficient knowledge of Microsoft Office.

• Good English language and grammar skills.

• Good presentation skills.