At a Glance
- Tasks: Support audits and ensure compliance in clinical trials while working remotely.
- Company: Join a global leader in precision medicine with a passion for rare diseases.
- Benefits: Fully remote position with opportunities for professional growth and development.
- Other info: Dynamic team environment with a commitment to diversity and inclusion.
- Why this job: Make a real impact in groundbreaking cancer research and be valued for your contributions.
- Qualifications: Bachelor's degree in science or healthcare; experience in GCP audits preferred.
The predicted salary is between 40000 - 50000 £ per year.
Precision for Medicine is a global Clinical Research Organisation. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. As our company continues to grow, we are seeking a full-time GCP Auditor to join our team. This position is offered fully remote.
As a GCP Auditor, you will support the audit program and clinical projects to ensure compliance with applicable regulations and Precision procedures. You will be responsible for providing oversight and subject matter expertise to quality and compliance activities, supporting project teams during all stages of a clinical study.
Essential functions of the job include but are not limited to:
- Support the Quality Management System including SOPs, training and CAPA Process and maintain documentation for controlled documents, as required
- Develop and administer training for employees and/or consultants
- Host client/sponsor audits and support regulatory inspections
- Coordinate and conduct assessments of potential and contracted vendors, including vendor audits as warranted
- Coordinate and conduct internal audits of quality systems
- Coordinate and conduct investigator site audits
- Coordinate and conduct trial master file audits
- Participate on computer systems validation projects and systems change control process
- Provide QA consultation and support to assigned project teams internally and externally
- Support and manage reported quality issues and any associated corrective and preventive actions
- Monitor quality systems to provide feedback on compliance risks to QA management and identify opportunities for improvement
- Maintain Q&C trackers, databases, metrics, and files
- Follow applicable regulations and standards, including but not limited to local regulations (US FDA and EU), ICH and company policies and procedures
Who we are seeking:
The ideal candidate will have extensive, working knowledge of managing audits in Clinical Trials environment: routine GCP audits, CRO process audits, Vendor Audits. Working knowledge of GCP/ICH guidelines and FDA regulations and standards. Bachelor’s degree in a science, healthcare, or related field of study; combination of qualifications and equivalent relevant experience may be accepted as an alternative. Availability to travel up to 25% domestically and/or internationally.
Preferred:
- 2 or more years’ experience in QA GCP department in a related industry
- QA certification preferred (e.g., CQA, SQA, etc.)
- Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.)
We invite you to learn more about our growing organization serving our clients that are researching groundbreaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.
GCP Auditor employer: Precision For Medicine
At Precision AQ, we offer a vibrant work environment where innovation meets collaboration, making us an exceptional employer for Project Managers in the HEOR space. Our culture mirrors that of a start-up within a well-established global organisation, providing ample opportunities for professional growth and development while working alongside industry leaders. With a focus on meaningful projects and a commitment to quality, you will thrive in a role that not only challenges you but also allows you to make a significant impact in healthcare outcomes.
StudySmarter Expert Advice🤫
We think this is how you could land GCP Auditor
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like Precision For Medicine looking for candidates who are engaged and informed.
We think you need these skills to ace GCP Auditor
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at Precision For Medicine. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at Precision For Medicine
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with Precision For Medicine’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
