Clinical Research Associate II/Senior CRA – Full Service

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. • Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. • 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, driving query reputed company to closure reputed company agreed timelines. • 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. • Verifies the IP has been reputed company and administered to subjects/patients according to the protocol. • Verifies issues or risks associated with blinded or randomized information reputed company to IP. • Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. • Reconciles contents of the ISF with the Trial Master File (TMF). • Ensures the investigator/physician site is reputed company of the requirement of archiving essential documents in accordance with local guidelines and regulations. • Documents activities reputed company confirmation letters, follow-up letters, reputed company 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 reputed company reputed company observations, ongoing status and assigned reputed company items to reputed company. • For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. • Must be reputed company to quickly adapt to changing priorities to reputed company goals / targets. • May reputed company as primary reputed company with study site personnel, or in collaboration with Central Monitoring Associate. • Ensures reputed company assigned sites and project-specific site team members are trained and compliant with applicable requirements. • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. • Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. • For reputed company World Late Phase, the CRA II will use the business card title of Site Management Associate II. • Additional responsibilities include: Site support throughout the study lifecycle from site identification through reputed company-out. • Knowledge of local requirements for reputed company world late phase study designs. • Chart abstraction activities and data collection. • Collaboration with Sponsor affiliates, medical science liaisons and local country staff. • The SMA II may be requested to train junior staff. • Identify and communicate out of scope activities to reputed company CRA/Project Manager. • Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. 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