Clinical Research Specialist

Há 7 horas

Rio de Janeiro, Brasil beBeeClinicalResearch Tempo inteiro

Clinical Research Associate Job Description This role plays a pivotal part in designing and analyzing clinical trials, interpreting complex medical data, and advancing innovative treatments and therapies. Onsite and remote monitoring activities are completed in accordance with ICH-GCP guidelines, applicable regulations, SOPs, and study processes. The protection of study participants is verified by confirming informed consent procedures and protocol have been performed in accordance with applicable regulations. Clinical data integrity is ensured, and the study is conducted in compliance with approved protocol, GCP, applicable regulations, and SOPs. The investigative site staff is managed to facilitate trial deliverables, such as subject enrollment and data deliverables. The Investigational Product (IP) is properly managed and accounted for. Reports of investigational site findings and updates to applicable tracking systems are written and submitted. Observed deficiencies, issues, and corrective and preventative action plans are escalated as appropriate. Essential documents are managed as required by local regulations and ICH-GCP guidelines before, during, and after a clinical study; data queries are resolved. A key risk assessment and management responsibilities are performed throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation. Audit preparation and follow-up activities are participated in as needed. A variety of onsite and offsite monitoring visit types are independently performed. Information for assigned sites is gathered and reviewed, and inconsistencies are identified. With limited guidance from project and functional management, risks are assessed and escalated as appropriate. Non-complex ad-hoc, short-term assignments are assisted with in support of additional studies or departmental initiatives. A preceptor role may be served, providing training to less experienced clinical team members. An undergraduate degree or international equivalent in a clinical, science, or health-related field from an accredited institution; healthcare professional licensure, i.e., registered nurse. Previous experience supporting clinical trials including solid on-site monitoring experience in CROs or pharma companies. Key Skills and Qualifications The ideal candidate will possess excellent communication and interpersonal skills. A strong understanding of ICH-GCP guidelines, regulatory requirements, and clinical research practices is necessary. Bachelor's degree in life sciences or related field. 2+ years of experience in clinical research or relevant industry. Strong understanding of ICH-GCP and regulatory requirements. Excellent communication and interpersonal skills. Why Join Our Team We offer a dynamic and supportive work environment that fosters growth and development. Our team is passionate about making a difference in people's lives through clinical research. About Us We are a leading global provider of contract research services. Our mission is to accelerate the delivery of safe and effective therapeutics to patients worldwide.

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