Ir à oferta completa

SPONSOR DEDICATED SR CRA I - HOME BASED PORTUGAL

Descrição da oferta de emprego

Description Sponsor Dedicated Senior Clinical Research Associate I - Home Based Portugal Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do.
We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
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 achieve their goals.
We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our employees, across 110 countries already know.
WORK HERE MATTERS EVERYWHERE Why Syneos Health 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 our Total Self culture – where you can authentically be yourself.
Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with.
Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job responsibilities Performs site qualification, site initiation, interim monitoring, site management 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 via review of site source documents and medical records 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.
Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; 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 project 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, and may, with supervision, lead, 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.
May provide training or mentorship to more junior level CRAs.
May perform training and sign off visits for junior CRA staff, as assigned.
May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager.
For Real World Late Phase (RWLP), the Sr.
CRA I will use the business card title of Sr.
Site Management Associate I.
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 As required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country 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 Identify operational efficiencies and process improvements Develop country level informed consent forms Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared Participate in bid defense meetings Qualifications What we’re looking for 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.
Basic level of critical thinking skills expected.
Ability to manage required travel of up to 75% on a regular basis Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across Sites and + Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.
Learn more about Syneos Health.
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 comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Ir à oferta completa

Detalhes da oferta

Empresa
  • Indeterminado
Localidade
  • Em todo Portugal
Endereço
  • Indeterminado - Indeterminado
Data de publicação
  • 31/10/2024
Data de expiração
  • 29/01/2025
Radioterapia I Reino Unido I NHS
Vitae Professionals

Oferta:- contrato permanente com o nhs;- visto de trabalho;- possibilidade de iniciarem sem hcpc - obrigatório fazer inscrição;- oferta de relocation package que inclui apoio com inscrição na ordem, mudança e exame de inglês;- 6 meses de treino e desenvolvimento de carreira para uma boa adaptação;- plano......

Channel sales portugal security systems
Grupo arestora

Main tasks: analyze the market in portugal region and better understand sales channel in portugal regions... maintain customer partnership in portugal improve brand market share and product coverage continually... 5 years or above experience of channel sales in it or relevant industry is preferred;......

Agentes necessários em toda Portugal
BricoDepot

Requisitos do trabalho sem experiência este é um trabalho de meio período que ocorre principalmente on-line, você pode fazê-lo no seu celular ou computador... você deve receber nosso convidado em portugalagentes necessários em toda portugal, este é um trabalho de meio período que ocorre principalmente......

Assistente administrativo francês em Lisboa, Portugal
SpotOn Connections

Nosso cliente, um provedor reconhecido de serviços em seguros de saúde e administração de fundos de pensão, está procurando um assistente administrativo francês para o seu escritório em lisboa, portugal... um compromisso de longo prazo e experiência na indústria de seguros é preferido......

GERMAN SPEAKING CUSTOMER SUPPORT AGENT REMOTE IN PORTUGAL
SpotOn Connections

If you are interested in the above position, kindly forward your cv to barbara luvisotto montagnini on *****@*****... join our team in portugal! responsibilities: answer to customer queries and requests, in a simple way keeping your smile, ensuring their satisfaction through a unique customer experience......

Mudou-se para Portugal e procura oportunidade? (m/f)
Century21Porto

Temo-nos apercebido que os profissionais que mudaram para portugal recentemente e começaram a trabalhar connosco são pessoas extremamente motivadas e empenhadas no seu trabalho... perfil: elevada capacidade de organização e gestão de tempo; carater responsável, proativo e empreendedor; fortes competências......

Calceteiro (m/f) - Zona Centro de Portugal
Altifel SA

Oferta:-vencimento inicial acima da média, variável de acordo com a experiência profissional anterior e outras valências demonstradas... requisitos mínimos:-experiência anterior na área da construção civil ou similar;-elevado sentido de responsabilidade e espírito de trabalho em equipa......

Intérprete | Crioulo Cabo-verdiano e Inglês (M/F) | Portugal
Get The Job

Se te identificas com o objetivo de melhorar a convivência entre diferentes culturas, então chegou a tua vez de fazer parte desta equipa de intérpretes e tradutores empenhados em oferecer serviços linguísticos de alta qualidade! quer seja uma consulta médica depois de um dia preguiçoso a apanhar sol......

Consultor(a) comercial segmento luxo i premium
Unpredictable talents

Boa capacidade de comunicação e argumentação... apenas serão contactados(as) os(as) candidatos(as) selecionados... acompanhamento permanenteassistência administrativa, jurídica, de marketing e comunicação... as melhores ferramentas tecnológicas do mercado... o que oferecemos: as melhores comissões do......

Consultor(a) comercial segmento luxo i premium
Unpredictable talents

Boa capacidade de comunicação e argumentação... apenas serão contactados(as) os(as) candidatos(as) selecionados... acompanhamento permanenteassistência administrativa, jurídica, de marketing e comunicação... as melhores ferramentas tecnológicas do mercado... o que oferecemos: as melhores comissões do......