Senior Clinical Research Associate, Level I

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🕒 Julho 14

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Thermo Fisher Scientific

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1956

🏥 Saúde

📦 Logística

🏭 Manufatura

Healthcare • Logistics • Manufacturing

A Thermo Fisher Scientific é a líder mundial em servir à ciência, com receita anual de mais de US$ 40 bilhões. Sua missão é capacitar os clientes a tornar o mundo mais saudável, limpo e seguro, apoiando a pesquisa em ciências da vida, solucionando desafios analíticos complexos, aumentando a produtividade dos laboratórios e melhorando a saúde dos pacientes por meio de diagnósticos e do desenvolvimento de terapias que transformam vidas. Com uma equipe global, oferece tecnologias inovadoras e serviços farmacêuticos por meio de marcas como Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon e PPD.

Descrição

• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. • Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. • Assess investigational product through physical inventory and records review. • Documents observations in reports and letters in a timely manner using approved business writing standards. • Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution. • May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. • Conducts monitoring tasks in accordance with the approved monitoring plan. • Participates in the investigator payment process. • Ensures a shared responsibility with other project team members on issues/findings resolution. • Investigates and follows-up on findings as applicable. • Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. • Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). • Performs QC check of reports generated from CTMS system where required. • Participates in investigator meetings as necessary. • Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. • Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. • Ensures trial close out and retrieval of trial materials. • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. • Conducts on-site file reviews as per project specifications. • Contributes to the project team by assisting in the preparation of project publications/tools, and sharing ideas/suggestions with team members. • Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc). • Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. • Responds to company, client and applicable regulatory requirements/audits/inspections. • Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. • Contributes to other project work and initiatives for process improvement, as required.

🎯 Requisitos

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor). • Valid driver's license where applicable. • In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

🏖️ Benefícios

• Professional development opportunities • Flexible working hours