Job DescriptionAs a Senior Clinical Research Associate (SCRA) at Parexel FSP you will be joining a team with a wide variety of experiences and knowledge. We're looking for people like you who want to grow personally and professionally. We recognize and uphold the importance of all peoplethe way we do thingsour quest for innovationand most importantlyour patients.You will have the opportunity to work with one of the global top 20 pharmaceutical companiesworking on oncology studies that deliver real impact.Parexel FSP will offer you world class technology and training catered to your individual experience. You can anticipate less travel and a lower protocol load in comparison to industry peers.If impactflexibilityand career development appeal to youParexel could be your next home.Position Purpose:The Senior Clinical Research Associate (SCRA) will act as the primary site contact and site manager throughout all phases of a clinical research studytaking overall responsibility of allocated sites.Primary Duties:- Coordinates and manages various tasks to achieve Site Ready. Participates and provides inputs on site selection and validation activities. Performs remote and on:site monitoring and oversight activities using various tools. Conducts site visits including but not limited to validation visitsinitiation visitsmonitoring visitsclose:out visits and records visit and non:visit contact reports. Collectsreviewsand monitors required regulatory documentation for study start:upstudy maintenance and study close:out. Communicates with Investigators and site staff on issues related to protocol conductrecruitmentretentionprotocol deviationsregulatory documentationsite audits/inspections and overall site performance. Manages and maintains information and documentation in Clinical Trial Management System (CTMS)Electronic Trial Master File (eTMF) and various other systems. Supports and/or leads audits/inspection activities as needed. Mentors / buddies junior CRAs on process/study requirements and performs co:monitoring visits where appropriate.Qualifications- B.A./B.S.preferred with a strong emphasis in science and /or biology. Minimum 4 years of direct site management and monitoring experience gained within bio/pharma/ or CRO required. Excellent understanding and working knowledge of clinical researchphases of clinical trialscurrent GCP/ICH and country clinical research law and guidelines. Excellent understanding of GlobalCountry/Regional Clinical Research Guidelines and ability to work within these guidelines. Fluent in local languages and English (verbal and written) and excellent communication skills.Why work at Parexel FSP:For results:driven and caring individuals who want to make a meaningful difference in the worldParexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we doand where an inclusive global community helps you be your besttransforming any career into a life:changing achievement.Why Work at Parexel There are pivotal moments in every career:Sharing new treatments. Improving processes. Delivering life:saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?That's Parexel. We're a diverse team of professionals focused on one goal:getting treatments into the hands of those who need them most. Working togetherthe results we bring to our clients and the opportunities we bring to our team get better with every step.How can we help you on your journey? Find your pathand learn more on LinkedIn YouTube Facebook Twitter and Glassdoor.
