Site Care Partner I
hace 1 semana
About Parexel FSP
Parexel FSP is a leading Contract Research Organization (CRO) that transforms scientific discoveries into new treatments. We are a company that conducts vital clinical studies for sponsors, including the world's leading biotech's and top 50 pharmaceutical companies.
About the Role
We are seeking a highly skilled Site Care Partner I to join our team. As a Site Care Partner I, you will be the main Client point of contact for investigative sites and accountable for safeguarding the quality and patient safety at the investigator site.
Key Responsibilities
- Ensure that sites receive necessary support and engagement, issues are resolved, and client's reputation is upheld throughout study lifecycle.
- Be the main client point of contact for investigative sites; accountable for site start up activities through activation; accountable for building and retaining investigator site relationships and providing support from site recommendation through the lifecycle of studies; accountable for site level recruitment and operational success, and accountable for safeguarding the quality and patient safety at the investigator site.
- Contribute to country and site selection activities by proactively collaborating with key stakeholders and providing local intelligence to country outreach surveys, investigator strategies and client pipeline opportunities under supervision.
Requirements
- A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology.
- Candidates for this job would hold the following levels of education/experience: BS/BSc/MS/MSc or equivalent + 5 years of clinical research experience and/or quality management experience.
- Skills in more than one language are an advantage in this role; English is required.
- Solid knowledge of clinical development processes with strong emphasis on monitoring.
- Demonstrated ability to oversee a 3rd party and/or demonstrated ability in Quality Assurance (preferred).
- Site Management/Monitoring (CRA) experience needed.
- Project management experience preferred in the clinical development area.
- Ability to lead, troubleshoot and influence for delivery.
- Experience implementing centrally designed and developed initiatives on a local basis.
- Demonstrated knowledge of quality and regulatory requirements for applicable countries.
- Demonstrated knowledge of site intelligence at country/cluster level in support of site recommendation.
- Demonstrated knowledge of clinical trial methodology and the drug development process, related to monitoring clinical trials, GCP, Food and Drug Administration (FDA), or country-specific regulatory environment.
- Demonstrated experience in site activation and startup.
- Demonstrated networking and relationship building skills.
- Demonstrated ability to manage projects and cross-functional processes.
- Availability to travel regularly within country and region is required (3 – 5 visits per month).
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