CRA II/Snr CRA

Location

United States

Posted

11 days ago

Salary

0

Seniority

Mid Level

No structured requirement data.

Job Description

CRA II/Snr CRA

Syneos Health

Role Description Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action 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 each subject/patient, as required/appropriate. - Demonstrates diligence in protecting the confidentiality of each subject/patient. - Assesses factors that might affect subject/patient’s safety and clinical data integrity 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 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. - Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within 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 perform investigational product (IP) inventory, reconciliation and reviews storage and security. - Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. - Verifies issues or risks associated with blinded or randomized information related 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 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. - 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 able to quickly adapt to changing priorities to achieve goals / targets. - May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. - Ensures all 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 Real 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 close-out. - Knowledge of local requirements for real 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 Lead CRA/Project Manager. - Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. 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. - Must demonstrate good computer skills and be able to embrace new technologies. - Excellent communication, presentation and interpersonal skills. - Ability to manage required travel of up to 75% on a regular basis. Requirements - US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. - Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. - Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. - You are required to comply with any such Site requests as a condition of your employment with Syneos Health. - Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. Benefits - We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. - We are committed to building an inclusive culture – where you can authentically be yourself. - Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. - We are continuously building the company we all want to work for and our customers want to work with.

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