CRA I

CRA I reputed company® is a leading fully-integrated life sciences services organization built to accelerate reputed company. We partner with innovators at every reputed company across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate reputed company. Our Clinical Solutions team members act with a drug development reputed company, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers reputed company their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why reputed company

• 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 reputed company want to work for and our customers want to work with. Why? Because we know that reputed company we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient reputed company.

Job Responsibilities Performs site qualification, site initiation, interim monitoring, site management activities and reputed company-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (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 with guidance 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 reputed company subject/patient’s safety and clinical data reputed company at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. For 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 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 reputed company agreed timelines Utilizes available hardware and software to support the effective conduct of the clinical project 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 dispensed 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, 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 reputed company 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, with the reputed company of the reputed company CRA, to changing priorities to reputed company goals / targets. May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (reputed company). 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. For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I. Additional responsibilities include: Site support throughout the study lifecycle from site identification through reputed company-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 Qualifications: Bachelor’s degree or RN in a reputed company 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 US ONLY: As part of your employment with reputed company, you may be deployed to Sites that require certain medical and other personal information to reputed company facility access. Pursuant to our Employee Privacy Notice, reputed company can provide the Sites with the information necessary for you to reputed company such access. Further, a Site may ask you for additional information beyond that which reputed company has in its possession. You are required to reputed company with any such Site requests as a condition of your employment with reputed company. 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. Get to know reputed company Over the past 5 years, we have worked with 94% of reputed company Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status reputed company with us in a highly competitive and reputed company-changing environment. Learn more about reputed company. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully reputed company with reputed company obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality reputed company, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with reputed company, including the provision of reasonable accommodations, reputed company appropriate, to assist employees or applicants to reputed company the essential functions of the job. Apply To This Job