Site Activation Partner I
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Job Description
Site Activation Partner at Parexel managing clinical trial operations from start-up to close-out. Ensuring compliance with timelines, laws, and Good Clinical Practices in Brazil.
Responsibilities:
- Responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Client standards.
- Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation.
- Register investigator sites and Client stakeholders in Client registries and systems as required.
- Work directly and interact with investigator sites to confirm readiness for site start-up by reviewing study site profile ready in Shared Investigator Platform (SIP) or reviewing/completing critical information Sheet.
- Take the lead to resolve issues or concerns and timely escalation of Site issues where applicable.
- Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines.
- Manage and coordinate with other supporting roles to ensure timely site activation and operational activities.
- Support the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study.
- Assist with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
Requirements:
- School diploma/certificate with equivalent combination of education, training and experience
- Minimum 2 years’ relevant experience in clinical site management
- Experience working in the pharmaceutical industry/or CRO in study site activation is preferred
- Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
- Good technical skills and ability to learn and use multiple systems
- Demonstrated knowledge of clinical research and development processes, Key operational elements of a clinical trial, and ability to gain command of process details
- Understand the quality expectations and emphasis on right first time.
- Demonstrate compliance with all applicable company, regulatory and country requirements.
- Attention to detail evident in a disciplined approach
- Ability to work independently and also as a team member
- Ability to organize tasks, time and priorities, ability to multi-task
- Understand basic medical terminology, GCP requirements and proficient in computer operations.
- Must be fluent in Local language and in English. Multilanguage capability is preferred.
Benefits:
- Health insurance
- Flexible work arrangements
- Professional development opportunities
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