Clinical Project Associate

Job content

Are you ready to take a step up to progress into Clinical Project Management?

Here is a great opportunity to grow into this role and work alongside experienced project managers as a Clinical Project Associate.

With previous experience in clinical trial administration and good knowledge and understanding of the roles within the clinical team, you can soon be setting up new trials from scratch, i.e., documentation, tracking systems, supporting the internal team and external sites and much more.

This is a great opportunity for an experienced Clinical Trial Administrator or a Clinical Research Associate looking to become a Clinical Project Manager, to get involved in almost every aspect of the set-up and maintenance of clinical trials. With a science related degree, and a minimum of 2 years’ experience in clinical trials you will quickly expand your knowledge and experience within this role, as you will be working within a small, versatile, multi-disciplinary team with a common goal.

Good proven computer skills, most importantly Microsoft Outlook, Excel, Word and PowerPoint. Knowledge of electronics systems (e.g., eTMF, file sharing platforms etc.) would be beneficial. Experience with Microsoft Project would be a great advantage.

Great communication skills are essential, written and spoken, as you will be working with external site personnel, service providers, suppliers as well as the internal team.

Quality matters, your ‘good eye for detail’ matters, your ‘willingness’ and ‘can-do attitude’ matters. In this highly regulated environment, quality and compliance are not negotiable.

This permanent role will be full-time and based in the Oxford area, so you must be within a commutable distance. In current times there may be flexibility to work from home, but ultimately your presence in the office with the team is required. The role comes with a comprehensive benefits package and competitive remuneration.

Key Roles & Responsibilities

• Working to regulatory requirements and within the company Quality Management System, keeping up to date with industry changes via self-training as well as organised internal or external training courses.
• Assisting the clinical trial team with trial start-up activities, involving scanning, filing, trial documentation (forms/templates) creation/review/formatting, database entry, sending and receiving documents, regulatory/ethical submission reviews etc.
• Creating new, and working with, existing tracking systems, updating and maintaining them on a regular basis in order to give instant clear status updates of the clinical trial activities.
• Tracking study recruitment and laboratory reports.
• Ensuring effective document version control and checking documents for accuracy and completeness.
• Preparing files for successful audit.
• Ordering, sending and tracking trial supplies.
• Tracking payments using budget sheets.
• Assisting the Clinical Operation Team in meeting regulatory standards and timelines, managing own workload, acting independently to prioritise tasks to meet all deadlines.
• Acting as central point of communication for complete study team, including study sites and CROs.
• Effectively communicating with internal and external team members, escalating any issues encountered in a timely manner.
• Assisting the study monitors in the preparation of monitoring visits and the review of Investigator Site Files.
• Organising external meetings, travel and accommodation.
• Attending company/team meetings as required.
• Maintaining confidentiality and security of company business at all times.
• Ad hoc administrative support, arranging meetings, note taking, etc.
• Forging effective working relationships with external service providers (e.g. Clinical Research Organisations for Trial Master File, laboratory services, courier, printing services etc.), overseeing outsourced work, ensuring efficient and effective performance.

PERSON SPECIFICATION

Education and qualifications

• Educated to degree level (life or medical science discipline).
• Excellent team-working skills with the ability to interact and communicate effectively (both verbal and written) with professionals in a multi-disciplinary team.
• Experienced in document management systems/electronic data rooms.

Key personal skills and abilities

• Knowledge of the clinical trial process and roles of the team members.
• Proven ability to take initiative and pro-actively contribute to role responsibilities.
• Strong written and verbal communication skills.
• Proven ability to prioritise, plan ahead and manage a high volume of work to meet deadlines, both prescribed and self-imposed.
• Methodical approach with meticulous record keeping and attention to detail with focus on quality.
• Highly organised, with the ability to use own initiative and work unsupervised, with a creative approach to problem solving.
• Excellent team-working skills with the ability to interact and communicate effectively with professionals in a multi-disciplinary team.
• Able to maintain confidentiality and personal integrity in all aspects of work.
• Able to cope under pressure and be flexible with changing priorities or unforeseen circumstances in a challenging environment.

Interested? Apply now, we are waiting to hear from you.

ALL APPLICANTS MUST BE ELIGIBLE TO LIVE AND WORK IN THE UK.

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