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For Companies At a Glance
- Tasks: Support clinical trials from start to finish, managing documentation and timelines.
- Company: Join Autolus Therapeutics, a diverse employer committed to inclusivity and the LGBTQ+ community.
- Benefits: Enjoy a collaborative work environment with opportunities for growth and learning.
- Why this job: Be part of impactful clinical research that makes a difference in patients' lives.
- Qualifications: No specific experience required; just a passion for clinical research and organization.
- Other info: Flexible tasks and responsibilities, perfect for students looking to gain real-world experience.
The predicted salary is between 36000 - 60000 £ per year.
Job Description
This job is with Autolus Therapeutics, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
Role Summary
The Clinical Project Associate will provide support to the Clinical Project Manager/ Clinical Programme Lead and related team members by performing generic clinical trial management procedures and tasks associated with the day to day running of clinical studies/programmes throughout the entire study lifecycle (start up, maintenance and close out); Ensure work is conducted in line with standard operating procedures, policies and good practices.
This is a key Coordination role which links the oversight of the Project Management across Autolus Departments and Vendors to ensure that all Depts and Functions are clear on tasks and timelines within the various projects as well as maintaining the administrative aspects of the trials.
Key Responsibilities
- To support the Clinical Project Manager in all areas of the study e.g. vendor management, country, site and patient management study set up through to close out. To maintain:
- study trackers and dashboards
- Project Management Plan: to update the Project Plan with key dates and milestones as decided by the CPM/CST and various Depts.
- Working with the Accountable CPM to maintain Gannt charts and project timelines
- spreadsheets on an ongoing basis, particularly Monday.com
- Working closely with the CPM and across Departments (including Data Management).
- Under delegation by the CPM: input and maintenance of the Project Management Plan, Risk Management Plan
- Coordination transversally with different Depts in a matrix environment to enable successful and timely study execution
- Tracking of Study Metrics where applicable (time to set up, open queries etc)
- To set up, organize and maintain clinical study documentation files (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, periodic checks, final reconciliations and archiving.
- Responsible for version control and filing of documents within Sharepoint and the TMF.
- Accountable for TMF Contents Management
- Works with the CPM on the Contents of the ISF and also putting together the ISF during site set up
- Maintaining the study TMF to ensure that the TMF is complete and working closely with Vendors to ensure that their Checklists are up to date
- Supports the filing, maintenance, tracking and archiving of Trial Invoices
- Under delegation of the CPM Preparation of EC/IRB submission packages, preparation of Investigator Site Files and distribution study materials to sites.
- Responsible for agendas, Powerpoint slide(s) preparation and meeting (actions) minutes of the Clinical Study Team; alongside meetings with vendors and Investigators
- Review and QC of study documents e.g. ICF
- Coordination of translation of study documents e.g. ICFs
- Responsible for tracking invoices, and maintain PO oversight
- Regular communication with clinical trial vendors to contact clinical sites for specific requests (e.g., enrolment updates, missing documentation, meeting arrangements, TMF management etc.)
- To take over responsibilities for certain specific areas of the project/vendors/mini projects of the clinical study as delegated by the CPM
- To serve as back-up for the CPM during absences
- To have individual ownership of specific tasks/Projects within the Project Management Team
- Understanding of regulatory and ethics processes and procedures in all sectors
- Flexibility to take on different organisational and administrative aspects of the trial
- Support the CSM Team (particularly with admin such as TMF filing and source doc management
#LI-DNI
Clinical Project Associate employer: Autolus Therapeutics
Contact Detail:
Autolus Therapeutics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Project Associate
✨Tip Number 1
Familiarize yourself with clinical trial management software like Monday.com, as this role heavily involves maintaining project timelines and dashboards. Being comfortable with these tools will show your readiness to hit the ground running.
✨Tip Number 2
Understand the importance of regulatory and ethics processes in clinical trials. This knowledge will not only help you in your role but also demonstrate your commitment to compliance and quality in clinical research.
✨Tip Number 3
Network with professionals in the clinical research field, especially those who have experience in project management. They can provide insights and tips that could be beneficial during your application process.
✨Tip Number 4
Be prepared to discuss your organizational skills and how you manage multiple tasks simultaneously. This role requires excellent coordination across various departments, so showcasing your multitasking abilities will be key.
We think you need these skills to ace Clinical Project Associate
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Clinical Project Associate position at Autolus Therapeutics. Understand the key responsibilities and required skills, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasize any previous experience in clinical trial management or project coordination. Use specific examples that demonstrate your ability to manage tasks, maintain documentation, and work with cross-functional teams.
Showcase Your Skills: Mention your proficiency with tools like Monday.com, SharePoint, and any other relevant software. Highlight your organizational skills, attention to detail, and ability to communicate effectively with various stakeholders.
Tailor Your Cover Letter: Craft a personalized cover letter that reflects your enthusiasm for the role and the company. Discuss why you are interested in working at Autolus Therapeutics and how your values align with their commitment to inclusivity and diversity.
How to prepare for a job interview at Autolus Therapeutics
✨Understand the Clinical Trial Lifecycle
Make sure you have a solid grasp of the entire clinical trial lifecycle, from start-up to close-out. Be prepared to discuss how you can support each phase and what specific tasks you would prioritize.
✨Familiarize Yourself with Project Management Tools
Since the role involves using tools like Monday.com for project tracking, it’s beneficial to familiarize yourself with these platforms beforehand. Highlight any experience you have with similar tools during the interview.
✨Showcase Your Coordination Skills
This position requires strong coordination across various departments. Prepare examples from your past experiences where you successfully managed multiple stakeholders or projects simultaneously.
✨Demonstrate Knowledge of Regulatory Processes
Understanding regulatory and ethics processes is crucial for this role. Brush up on relevant regulations and be ready to discuss how you would ensure compliance in your work.
