Senior Clinical Trial Associate

Catalyst Clinical Research LLC; United Kingdom; On-site; GBP 35,000 - 55,000; Full time

Job summary

An established industry player in clinical research is seeking a Senior Clinical Trial Associate to provide vital administrative support for clinical development teams. In this role, you will ensure compliance with ICH-GCP guidelines while managing documentation and coordinating trial activities. Your expertise will help streamline processes and enhance communication with investigators and study staff. This position offers an opportunity to work in a dynamic environment where your contributions will directly impact the success of clinical trials. If you are passionate about improving patient outcomes through innovative research, this role is perfect for you.

Qualifications

• 2+ years' experience in clinical trial processes and regulatory standards.
• Experience in maintaining Trial Master Files in compliance with ICH-GCP.

Responsibilities

• Support clinical trial activities in accordance with SOPs and ICH-GCP.
• Coordinate collection of essential documents during site set-up.
• Manage clinical trial supplies and maintain trial tracking systems.

Skills

ICH-GCP Knowledge

Clinical Trial Processes

Documentation Management

Communication Skills

Organizational Skills

Technical Skills (PowerPoint, Excel, Word)

Education

Degree in Life Sciences or Nursing

Job description

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.

As a Senior Clinical Trial Associate you are responsible for providing the administrative support to the clinical development/project teams and maintaining a range of clinical documentation. You will be focused on supporting external client teams as well as our internal Clinical Services team. You will work closely with project teams to ensure that Clinical Trial Administration is performed in line with ICH-GCP allowing successful delivery of trials whilst protecting subjects' rights, safety and wellbeing and the production of reliable clinical trial data.

Position Accountabilities/Responsibilities:

• Support the clinical trial activities with regard to time, cost and quality and in accordance with SOPs, ICH-GCP guidelines and relevant regulations
• Set up and maintain the documentation folders associated with product development and the Trial Master File (TMF) in compliance with ICH-GCP
• Ensure the TMF index is kept up to date
• Coordinate the collection of essential documents during site set-up
• Assist in the development of processes and procedures in order to ensure that robust forecasting and scheduling of trials occurs
• Assist the project managers in the production of study reports and updates as required
• Set up trial specific meetings, taking minutes and tracking screening and enrolment across clinical sites
• Track and process investigator site payments
• Manage the clinical trial supplies for a study, including the tracking and shipment of materials e.g. lab kits
• Assists the project team with preparation and shipment of Clinical Trial documentation including: Investigator Site File, Pharmacy File, Investigator Brochure, Protocol and study manuals.
• Update and maintain trial tracking systems in accordance to the demands of the study e.g. investigational product tracking, payment tracking, monitoring visit tracking etc.
• Serve as an office-based point of contact for all sites during the trial
• Develop and maintain good working relationships with Investigators and study staff
• Assist with corporate administration activities according to need and availability

Position Qualifications and Requirements:

Education: Degree or equivalent qualification in life sciences or nursing

Experience:

• • 2+ years' experience in clinical trial processes and procedures including regulatory standards

Required Certifications: N/A

Required Skills:

• A good understanding of ICH-GCP and regulatory requirements
• Proven track record in working within clinical research in the pharmaceutical, CRO or NHS environment
• Experience in maintaining Trial Master Files/Investigator Site Files in compliance with ICH-GCP (ideally experience in using the DIA reference model).
• Ability to work collaboratively with others, influencing and managing conflict
• Willingness and ability to travel domestically (and occasionally internationally) as required
• Excellent verbal and written communication and interpersonal skills
• Strong organisational and time management skills with an ability to multi task and work independently
• Strong technical skills using PowerPoint, Excel and Word

Working Conditions: Sedentary work that primarily involves sitting/standing. Employee may be office or home based.