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 aware 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

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