Senior CRA - SSU Focus - FSP
Source: Himalayas
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Parexel is seeking an experienced Senior CRA in the UK with a focus on Site Start-Up (SSU) activities for oncology trials. This remote, full-time role involves managing site selection, qualification, and initiation, acting as a key liaison between sponsors and sites, and ensuring timely document uploads. The ideal candidate must have at least 3 years of independent monitoring experience and in-depth SSU expertise, with oncology trial experience being essential.
Job Description
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 is currently seeking an experienced CRA to join us in the UK. You will be assigned to one of our key sponsors in the region, focusing on SSU visits and activities for your assigned trials in the UK.Whether you see your future path in fields such as clinical operations, project management, line management, or other positions, we have a world of opportunity waiting for you.Some specifics about this advertised roleDedicated to one client.Responsible for the selection and set-up of clinical studies up to site initiation.Performs Site Qualification Visits (on site or remote), completes SQV reports and inputs into site selection.Ensures that all study site documents under their responsibility are available, have been reviewed and uploaded to CTMS prior to site activation.Customizes plans with site team (eg. site recruitment plan, source data agreement)Acts as the main line of communication between the sponsor and the site team during study set-up.Trains, supports, and advises Investigators and site staff including pharmacy and other support departmental staff in study related assessments.Actively participates in local study team and set-up team meetings.Uploads time critical documents to eTMFHere are a few requirements specific to this advertised role.Minimum of 3 years' experience independent monitoring.In depth experience of performing SSU activitiesOncology trial experience is essential and only candidates with oncology trial experience can be considered.BSc in life sciences is preferredWe care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.Who are ParexelParexel 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.Not quite the role for you?Join Our Talent Community and we’ll reach out with job alerts when positions that match your career interests become available. We’ll also share periodic updates about the latest company news and events.Sign up today https://jobs.parexel.com/functional-service-providerOriginally posted on Himalayas
Full Description
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 is currently seeking an experienced CRA to join us in the UK. You will be assigned to one of our key sponsors in the region, focusing on SSU visits and activities for your assigned trials in the UK.Whether you see your future path in fields such as clinical operations, project management, line management, or other positions, we have a world of opportunity waiting for you.Some specifics about this advertised roleDedicated to one client.Responsible for the selection and set-up of clinical studies up to site initiation.Performs Site Qualification Visits (on site or remote), completes SQV reports and inputs into site selection.Ensures that all study site documents under their responsibility are available, have been reviewed and uploaded to CTMS prior to site activation.Customizes plans with site team (eg. site recruitment plan, source data agreement)Acts as the main line of communication between the sponsor and the site team during study set-up.Trains, supports, and advises Investigators and site staff including pharmacy and other support departmental staff in study related assessments.Actively participates in local study team and set-up team meetings.Uploads time critical documents to eTMFHere are a few requirements specific to this advertised role.Minimum of 3 years' experience independent monitoring.In depth experience of performing SSU activitiesOncology trial experience is essential and only candidates with oncology trial experience can be considered.BSc in life sciences is preferredWe care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.Who are ParexelParexel 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.Not quite the role for you?Join Our Talent Community and we’ll reach out with job alerts when positions that match your career interests become available. We’ll also share periodic updates about the latest company news and events.Sign up today https://jobs.parexel.com/functional-service-providerOriginally posted on Himalayas