Senior Clinical Research AssociateFull-timeCompany DescriptionWe are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.PSI’s business is about conducting clinical research of novel medications. We work at the interface of R&D, pharmaceutical industry and healthcare science and provide services to big and mid-sized pharmaceutical companies. We help our clients to generate data about safety and efficacy of medications and bring the best ones to market. By conducting global clinical research trials, PSI makes cutting-edge treatment available in drugstores all over the world and helps patients with serious medical conditions to improve or even save their life. Help us to make sure that PSI medical and business documents are clear to patients, physicians, regulatory authorities, and clients.We offer an inspiring story of the company that has grown organically from a handful of countries to global presence. PSI is a mature company with standards and practices, but we do not stand still. Every day, there is a figurative Everest to climb, and you will not get bored here.Job DescriptionWe’re searching for a knowledgeable, team-oriented Senior CRA to manage the clinical aspects of full-service global projects in Taiwan. As a Senior CRA at PSI, you will work on the frontline of communication with project stakeholders, ensuring the successful conduct of clinical trials in a variety of therapeutic indications. You will maintain the highest quality standards in the industry, while performing and supervising study start-up, clinical monitoring and site management activities on the country/regional level.Location: Taipei, TaiwanTraining, mentoring and supervising study level responsibilities for Junior CRAsPreparation, conduct, and reporting of selection, initiation, routine and closeout monitoring visitsDelivering training of investigators, site staff and project teamsWork with complex studiesPerform CRF review, source document verification and query resolutionBe responsible for site communication and managementBe involved in site identification processContact for clinical investigators, vendors and support services in regard to study progressParticipate in feasibility researchPreparation and delivering of presentations at Investigator’s MeetingsPreparation for and attendance at company’s audits; resolution of audit findingsSupport to Regulatory Affairs in procurement of site regulatory documentsMaintenance of study-specific automated tracking systemsQualificationsCollege/University degree in Life Sciences or an equivalent combination of education, training & experienceMinimum of 4-5 years of demonstrable, independent on-site monitoring experience or equivalent expertiseExperience in Inflammatory Bowel Disease, Oncology, Infectious Diseases is a plusExtensive experience in conducting all types of monitoring visits in Phase II and/or III clinical trials.Proficiency in feasibility assessment and study set-up processes is highly desirable.Demonstrated ability to plan effectively, multitask efficiently, and thrive in a dynamic team environment.Superior communication, collaboration, and problem-solving skills are essential.Willingness and ability to travel.If you like to train and support others on their clinical research steps, and are also looking forward to future Lead Monitor roles, this position may just be the right one for you.Additional InformationWhat you’ll get:Competitive salaryWe offer hybrid work arrangement - 2 days flexi and 3 days in officeDevelopment and learning opportunitiesChance to make a real impact in a meaningful industryPSI is a passionate, organically grown, and award-winning full-service CRO who dares to be different. As a dynamic and global company, we bring together more than 3000 driven and dedicated experts across 60 countries working collectively to help make a positive impact on patient lives.How are we different?PSI is privately owned by the very people who founded the company 30 years ago, and they’re still working here today. As a result, we have grown organically around the globe and have kept our company fully independent, giving us significant advantages and freedoms.Being a Part of the TeamAs a part of the PSI team, you will have a fair degree of ownership and autonomy to make nuanced country-and department-specific adjustments while nurturing the global PSI culture that unites us across six continents.You will receive continuous support from your global peers and join a fast-paced, innovative, and results-oriented working environment with lean communication lines. We pride ourselves on being approachable, receptive to new ideas, and open to feedback.Growth OpportunitiesPSI is proud to invest in our people, from entry-level team members to senior leaders, helping you identify and hone your unique strengths at every step of your career. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career.By clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy applyI'm interestedI'm interestedPrivacy Notice
