Site Care Partner/SCRA - FSP - Remote

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel are currently recruiting for an experienced Senior CRA to join one of our key sponsors in Europe, based in Norway you will be working on sites throughout the country,

As a Site Care Partner, you will be the main client point of contact for investigative sites throughout a study life cycle and be the face of the client; 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. 

You will be a Subject Matter Expert helping to optimize 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.  

Some specifics about this advertised role

Site Start Up and Activation:

• Deploy GSSO site strategies by qualifying and activating assigned sites
• Supports processes to optimize country & site selection activities including review and assessment of the draft potential site list & provide PTA output for site selection.
• Supports the Feasibility Strategy and Analytics Lead to ensure that high quality feasibility results are delivered
• Collaborate with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices (as applicable).
• Provide country/regional level input to country strategy, feasibility, and protocol design in collaboration with relevant Medical Affairs colleagues, and with input from external clinical experts as required.

Study Conduct and Close Out:

• Act as operational point of contact for all site-level questions, liaising with and escalating to appropriate teams to respond and resolve questions.
• Review Site Monitoring Reports
• Support the site with revision and submission of ICD documents (and amendments).
• Working with other roles, maintain system management (e.g., EDC , Shared Investigator Platform, Site Profile and other systems as applicable) at site level ensuring alignment across platforms.
• During the conduct of the study, the Site Management Organization Assessment is reviewed with the site, when applicable, on an annual basis following site initiation and updated as needed. In addition, the SMO Assessment is reviewed and updated when major staffing, contracting, or other significant site changes/issues occur to confirm that continuity and contingency plans are current.
• Review and manage site practices that differ from client practices and liaise with study management and Business Process Owners as needed.
• Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback.

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

You’ll be an influential member of the wider team.

What we are looking for in the this role

For every role, we look for professionals who have the determination and courage always to put patient well-being first.

That to us is working with heart.

Here are a few requirements specific to this advertised role.

• Previous in depth experience working as a Senior CRA within oncology studies
• In depth experience working with challenging clinical trial sites
• Experience building and developing strong working relationships
• Masters Degree ideal but not essential.