Senior CRA - SSU Focus - FSP at Parexel

, , United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

07 Feb, 26

Salary

0.0

Posted On

09 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trials, Site Qualification, Oncology Trials, Site Activation, Study Set-Up, Investigator Training, Site Communication, Document Management, Team Collaboration, Regulatory Compliance, CTMS, eTMF, Source Data Agreement, Recruitment Planning, Monitoring, Life Sciences

Industry

Pharmaceutical Manufacturing

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 role Dedicated 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 eTMF Here are a few requirements specific to this advertised role. Minimum of 3 years' experience independent monitoring. In depth experience of performing SSU activities Oncology trial experience is essential and only candidates with oncology trial experience can be considered. BSc in life sciences is preferred We 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 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. 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-provider Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.

Responsibilities

The Senior CRA will be responsible for the selection and set-up of clinical studies up to site initiation, performing Site Qualification Visits, and ensuring all study site documents are available prior to site activation. They will act as the main line of communication between the sponsor and the site team during study set-up and provide training and support to site staff.