Senior Clinical Research Associate (CRA)

Вакансия № 4-15828688 в городе (населенном пункте) ОАЭ от работодателя "Confidential" на сайте www.RABOTKA.com.ru "Агрегатор вакансий".

Город, регион: ОАЭ (населённый пункт) места работы.

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Компания: Confidential (организация, фирма, ИП);

Репутация работодателя Confidential:

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Зарплата: от 2500 американских долларов;

Требования к работнику:

Дополнительные требования:
не указаны

Дополнительное описание вакансии:
We are a team of clinical trial experts who are dedicated to the success of our clients, so that ultimately patients can receive much-needed treatments. Our CRAs are responsible for remote site qualification, initiation, interim monitoring, site management and study close-out visits for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). This position will ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Experience: 5+ years' experience with research related activities with clinical practice, ICH guidelines, FDA and MoH regulations, IND and SAE reporting, and protection of human research participant standards, regulations, and laws. Experience in Infectious Disease, Rare Disease or Respiratory would be plus. Certifications: Clinical Research Certification CCRC/CCRP is preferred. Job Description: Provide leadership and direction to clinical site management team members from study start through to closure. Point of escalation for clinical site management and investigator sites. Drafting (and finalizing) the Clinical Monitoring Plan (CMP) and customization of WCT monitoring visit report/letter templates, site/monitoring tools. May assist in the design and development of additional study-related documents including (but not limited to) Informed Consent Form (ICF) templates, Case Report Forms (CRFs), CRF guidelines/instructions Data Management Plan, etc. Training and management of CRA team on all clinical aspects of the study with support from Project Management, Medical Monitoring, and Sponsor as needed. Ensures the CRA team is staffed to meet the monitoring demands of the project or program in compliance with the approved budget and CMP. Supports Project Management in the development of an implementation of a recruitment strategy in countries and sites assigned. Along with the Project Manager, LCRA will lead the tracking of recruitment and revision of site-specific recruitment plans as needed to ensure enrollment stays on target. Works with Project Management to take responsibility for the quality of the site data and addressing any identified needs with action plans with measurable metrics to ensure data cleaning is completed as specified. Supports Project Management in the review of data trends and trip report issues identified for re-training of sites or CRA team. Escalate issues and trends per study expectations. Formulates regional monitoring strategy and accountable for Forecasting of site visits w/CRA team in line with CMP to ensure staffing needs are met and any identified backlog is appropriately addressed. Review/finalize trip reports according to SOPs, expectations and as outlined in the annotated report Ensures all project follow up letters are prepared and follow up actions from stakeholders (any site visits) are closed. May perform site qualification, initiation, interim monitoring, and/or closeout site visits as needed. If budgeted, conduct co-visits for the specific study. The focus of the visit is to ensure the quality of the site, of the CRA work and of the study procedures. Act as the main line of communication between the sponsor and the investigator developing and writing trial protocols (outlining the purpose and methodology of a trial); presenting trial protocols to a steering committee; designing data collection forms, known as case report forms (CRFs); coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects; managing regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs; identifying and assessing the suitability of facilities to be used as the clinical trial site; identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site; liaising with doctors/consultants or investigators on conducting the trial; setting up the trial sites, which includes ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product. Plus training the site staff to trial-specific industry standards; monitoring the trial throughout its duration, which involves visiting the trial sites on a regular basis; verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV); collecting completed CRFs from hospitals and general practices; writing visit reports; filing and collating trial documentation and reports; ensuring all unused trial supplies are accounted for; closing down trial sites on completion of the trial; discussing results with a medical statistician, who usually writes technical trial reports; archiving study documentation and correspondence; preparing final reports and occasionally manuscripts for publication Provide management to the clinical research assistants to ensure that their role and contribution is optimized. Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. Education/Eligibility: A minimum of 5+ years' field monitoring experience required. BA/BS degree in biology, science, nursing or other clinical research-related area or equivalent education and experience required. Must have previous experience as a Lead CRA (or equivalent) or Project Management role coordinating clinical operations activities. Excellent written and verbal English communication skills required. Recent experience in Infectious Disease, Rare Disease or Respiratory would be plus. Bachelor degree in science or equivalent is required. Who can join immediately. Willingness to travel required.

Вакансия № 4-15828688 относится к сфере деятельности: "Медицина, фармацевтика" » "Клинические исследования".

Вы можете перейти к просмотру актуальных предложений работы выбранного населенного пункта с учетом сферы деятельности вакансии № 4-15828688: "Медицина, фармацевтика в населенном пункте текущего места труда" » "Клинические исследования в населенном пункте текущего места труда".

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(Переходите на веб-страницу сайта-партнёра «Служба Занятости Населения (электронная)» с вакансией № 4-15828688 на должность "Senior Clinical Research Associate (CRA)" в городе (населенном пункте, регионе) ОАЭ, где находится телефон, Telegram, Skype, Viber, WhatsApp, E-mail, адрес работодателя "Confidential")