Job Description Senior Clinical Research Associate -Oncology at ClinChoice (View all jobs) United Kingdom ClinChoice isa global full-service CRO dedicated to professional development andproviding an excellent work-life balance, with a quality-focused,collaborative “one-team” culture. We are looking for two dynamicprofessionals to join our in-house team as a Senior ClinicalResearch Associate (Senior CRA) on a permanent basis. You will beworking on 2-3 trials, where you will be responsible for sitemanagement (including start-up), both on-site and remotely, whileworking on projects from our varied client base, ranging from smallto big pharmaceutical, biotechnology, medical device and consumerhealth companies. Previous experience monitoring oncology and/orrespiratory clinical trials is required. Join our team: you can bepart of making a difference in peoples' lives and experience afulfilling and rewarding career! Main Job Tasks andResponsibilities: - Keep professionally abreast of all scientific,regulatory and operational aspects relevant to the clinicalprojects assigned. - Assist in the selection of sites, siteevaluation visits, initiation visits and ensure follow-up byobtaining the pre-study documentation to ensure good start-up ofthe investigation sites. - May act as Feasibility Associate. -Train site staff in all study procedures. - Conduct periodicmonitoring visits, including completion of monitoring visit report.Review at each visit the accuracy, legibility, completeness andquality of the Case Report Forms (CRF). - Conduct source dataverification and in-house review of clinical data and ensure timelyresolution of data queries to guarantee reliable clinical data. -Manage the investigational products (storage, inventory, dispensingrecords, packaging and labelling) and the trial material(Investigator Study File (ISF), CRF, questionnaires, diaries, etc.)to ensure timely and correct supply to the site. - Cooperate withthe site staff to ensure proper reporting from the site for safetyissues (AEs, SAEs, SUSARs, etc.) and their follow-up, guaranteeingtimely and appropriate handling of safety issues. - Conduct andreport study termination and related activities (e.g. archiving)guaranteeing smooth completion of the project. - Act as the maincontact person for the site in order to ensure close follow up. -Provide general support to the Clinical Research Division onquality control of clinical data. - Address appropriate teammembers about any issues that can jeopardise the conduct of theclinical projects assigned in a timely manner. - Report to the Headof department on all activities performed during the study and sendall relevant documents according to the timelines and therequirements agreed for each single clinical trial. - Developtraining material and give training in collaboration with theTraining & Qualification Management Unit. - May assist withcontract negotiation with sites on study budget after appropriatetraining. - Assist with the preparation of the study, including CRFdesign/development, write CRF instructions and organise the studyfiles and documents to ensure good start-up of the investigationsites. - May support the submission process in the projectincluding submission requirements, timelines, informed consentdevelopment, etc.. - Guide and supervise Clinical ResearchAssociate I (CRA I) in order to coach and train them on the job.Education, Experience and Skills: - University Degree inscientific, medical or paramedical disciplines. - Proven experienceas a CRA, performing on-site monitoring activities. - Experiencewith oncology or respiratory trials is required. - Strong knowledgeof clinical trial operations, GCP/ICH Guidelines and otherapplicable regulatory requirements. - Fluent in English and locallanguage(s). - Proficiency in Microsoft Office (e.g., Word, Excel,Outlook). - Willingness to travel. The Application Process Once youhave submitted your CV, you will receive an acknowledgement that wereceived it. If you have the requirements we need, you will beinvited for phone interview as the first step. Unfortunately, dueto the number of applications we receive, we cannot reply toeveryone individually if you are not successful. Who will you beworking for? About ClinChoice ClinChoice is a global full-serviceCRO specializing in clinical development and functional solutionsfor pharmaceutical, biotechnology, medical device, and consumerhealth companies. We have over 28 years of proven high-qualitydelivery and results across all our services with over 4,000professionals in more than 20 countries across the Americas,Europe, and Asia-Pacific. We are on a mission to contribute to ahealthier and safer world by accelerating the development andcommercialization of innovative drugs and devices. Join ourpassionate team and make a meaningful impact on global healthcare!Our Company Ethos Our mission drives our culture: to contribute toa healthier and safer world by accelerating the development andcommercialization of innovative drugs and devices. Our employeesare the most valuable company asset and they are the fulcrum aroundwhich all ClinChoice activities are built and close management andtraining is the core instrument to develop and maintainhighly-qualified personnel. The continuous training keeps theresources qualified in terms of competence and expertise and givesto all personnel the clear tools needed to manage both internal andclient processes with the same methodology. The success of thesecore values is evidenced by our below industry average turnoverrates. ClinChoice is an equal opportunity employer. We have basedour success on attracting, developing, and promoting talent guidedby diversity and inclusivity. Our employees come from very diversebackgrounds: gender, race, beliefs, and ethnicities. We recognizethis is our strength and celebrate it. Key words: Clinical ResearchAssociate, CRA, Site Management, Site Manager, Monitor, Monitoring,Oncology, Rare Disease, Rheumatology, Respiratory, Travel,Submissions, Ethics, CRO, Contract Research Organisation#LI-LG1
