# CRA II/ Sr CRA phase I **Company**: Syneos Health **Location**: DEU-Remote **Work arrangement**: remote **Experience**: senior **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/DEU-Remote/CRA-II--Sr-CRA-phase-I_25113071?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_4e4c8845-afb ## Description Syneos Health is seeking a senior CRA for one of its clients, a biopharmaceutical company. The successful candidate will have demonstrated proficiency in traditional on-site monitoring models, including full source data verification, investigational product accountability, and strict adherence to ICH/GCP and regulatory requirements. **Job Responsibilities** - Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. - Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site. - Conducts Source Document Review of appropriate site source documents and medical records. - Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records. - Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary. - May perform investigational product (IP) inventory, reconciliation and reviews storage and security. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. - Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. - Supports subject/patient recruitment, retention and awareness strategies. - Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. - Understands project scope, budgets, and timelines for own and others' activities in the clinical team. - May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate. - Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. - May provide training or mentorship to more junior level CRAs. **Qualifications** - Bachelor's degree or RN in a related field or equivalent combination of education, training and experience - Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements - Experience as CRA with a strong background in oncology clinical trials across all phases of development - Must demonstrate good computer skills and be able to embrace new technologies - The ideal candidate will have hands-on experience supporting solid tumor indications such as melanoma, breast, ovarian, prostate, and lung cancer. - Phase I oncology experience is essential for this role - Excellent communication, presentation and interpersonal skills. - Multilingual capabilities, English and German - Ability to manage required travel of up to 75% on a regular basis ## Skills ### Required - Good Clinical Practice - ICH Guidelines - oncology clinical trials - computer skills - English - German ### Nice to have - solid tumor indications - Phase I oncology experience - Toll-Like Receptor (TLR) pathways - PARP1 inhibitors - Werner helicase protein --- Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/DEU-Remote/CRA-II--Sr-CRA-phase-I_25113071?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)