Site Activation Partner I
hace 3 semanas
Parexel FSP is seeking a highly skilled Site Activation Partner I to join our team. This role is responsible for leading or supporting operational activities from start up to close out, for assigned studies and investigator sites.
Key Responsibilities- 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.
- Provide support to resolve issues or concerns and timely escalation of site issues where applicable.
- Prepare, validate and submit regulatory documents such as completed IIP, Institutional Review Board (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.
- Post site activation, initiate and coordinate activities and essential documents management with the investigator's sites towards the compilation of a high quality documents and updates through the life cycle of a study such as the documents management for protocol amendments, FDA 1572/Attestation revisions, ethics committee annual approvals and other activities required during study conduct.
- Ensure maintenance of IRB/Ethics and other committees' activities as applicable.
- Responsible for timely filing of documents to Trial Master File (TMF) and assisting with periodic quality review of study files for accuracy and completeness.
- Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines.
- Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests.
- Provide functional updates on a country and site level as required.
- Establish tools for efficient updates to study team as needed regarding site status, issues, delays, approvals.
The ideal candidate should have a Bachelor of Science or Bachelor of Arts degree or equivalent, with a minimum of 2 years relevant experience in clinical site management.
This position requires knowledge of clinical research and development processes, key operational elements of a clinical trial, and ability to gain command of process details.
The estimated salary for this role is $60,000 - $80,000 per annum, depending on location and experience.
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