Role Description
Sponsor Dedicated CRA I - Home Based Portugal
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Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, informed consent forms, and case report forms.
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Develop and implement tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and templates.
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Contribute to the design, implementation, and delivery of processes, programs, and policies, including participating in the development of standard operating procedures (SOPs) and training materials.
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Manage defined components of projects or processes within the area of responsibility, such as coordinating site visits, tracking study progress, and resolving issues.
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Ensure accurate and timely documentation of monitoring activities and findings, including writing monitoring reports, follow-up letters, and action plans.
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Collaborate with cross-functional teams to support clinical trial operations, including working with investigators, site staff, and other stakeholders to ensure smooth study conduct.
Qualifications
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Bachelor's degree in a related field or equivalent experience.
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Minimum of 1 year of experience in clinical research monitoring.
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Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements.
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Excellent communication and interpersonal skills.
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Ability to work independently and manage multiple priorities.
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Proficiency in using clinical trial management systems and other relevant software.
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Location in Lisbon area will be preferred.
Requirements
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Attention to detail and strong analytical skills.
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Problem-solving abilities and critical thinking.
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Ability to work effectively in a team environment.
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Strong organizational and time management skills.
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Proficiency in Microsoft Office Suite.
Benefits
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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.
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We are committed to building an inclusive culture β where you can authentically be yourself.
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We are continuously building the company we all want to work for and our customers want to work with.
Company Description
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 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, youβll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.