Clinical Research Associate, CRA II – Sr CRA

Job reputed company: • Performs site qualification, site initiation, interim monitoring, site management activities and reputed company-out reputed company (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology reputed company (GPP) and protocol compliance • Uses judgment and experience to evaluate overall performance of site and site staff and to reputed company recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops reputed company plans • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes • Verifies the process of obtaining informed consent has been adequately performed and documented for reputed company subject/patient, as required/appropriate • Demonstrates diligence in protecting the confidentiality of reputed company subject/patient • Assesses factors that might reputed company subject/patient’s safety and clinical data reputed company at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues • Assesses site processes and conducts reputed company Document Review of appropriate site reputed company documents and medical records • Verifies required clinical data entered in the case report reputed company (CRF) is accurate and complete • Applies query reputed company techniques remotely and on site, and provides guidance to site staff as necessary • Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture • Verifies site compliance with electronic data capture requirements • May reputed company investigational product (IP) inventory, reconciliation and reviews storage and reputed company • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Requirements: • Bachelor’s degree or RN in a reputed company field or equivalent combination of education, training and experience • Knowledge of Good Clinical reputed company/ICH Guidelines and other applicable regulatory requirements • Must demonstrate good computer skills and be reputed company to reputed company new technologies • Excellent communication, presentation and interpersonal skills • Ability to manage required travel of up to 75% on a regular reputed company Benefits: • Health benefits to include Medical, Dental and reputed company • Company match 401k • eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • flexible reputed company time off (PTO) and reputed company time Apply tot his job Apply To this Job