In-House CRA II/ Senior

Precision for Medicine; City Of London; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading clinical research organization in the UK is seeking an In-House CRA II/Senior In-House CRA to provide support for clinical research studies. This role involves assisting with investigator recruitment, ensuring compliance with study requirements, and managing site interactions. The ideal candidate will have a Bachelor's degree, at least 2 years of CRA experience, and strong proficiency in oncology clinical trials. This position offers an opportunity to work in a dynamic environment with a focus on precision medicine.

Qualifications

• Minimum of 2 years of relevant experience as a CRA or In-House CRA.
• Fluency in English (spoken and written).
• Ability to travel as needed.

Responsibilities

• Assist with investigator recruitment activities using phone scripts.
• Schedule internal and external meetings as required.
• Perform ongoing essential document collection and review.
• Act as site contact for study management issues.
• Ensure timely and complete data entry by sites.

Skills

Strong experience in oncological clinical trials

High proficiency in Microsoft Office

Attention to detail

Education

Bachelor's degree or equivalent

Job description

Overview

In-House CRA II/ Senior In-House CRA position in the UK with Precision for Medicine. The In-house CRA II/Senior In-House CRA provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, SOPs and all applicable guidelines and regulatory requirements (e.g., ICH-GCP, GPP, and country/region-specific regulations). Acts as point of contact for study sites. The In-house CRA II is a solid team member who can execute core responsibilities across several studies using independent judgment and critical thinking, working independently as a study team member with minimum support in complex activities.

Note: This description retains the core responsibilities and qualifications of the role.

Responsibilities

• Assist with investigator recruitment activities using phone scripts, questionnaires, study site materials and other tools for evaluating investigative sites.
• Assist in identifying study sites by performing site feasibility and recruitment tasks (e.g., completing, disseminating, and reviewing responses to site recruitment questionnaires).
• Schedule internal and external meetings as required.
• Prepare Investigator Site Files for distribution to study sites (electronic or physical), coordinating with shipping vendor if required.
• Perform ongoing essential document collection and review, maintenance, and close-out activities, organizing and maintaining site-level data in the trial master file (TMF) under general supervision to ensure sponsor and investigator obligations are met and compliant with ICH/GCP and local regulations.
• Assist with setup and maintenance of site-related data in clinical systems; utilize CTMS to track milestones and activities accurately.
• Act as site contact/liaison for study management issues; address questions, assist with study supplies, and support offsite central monitoring as needed; escalate issues and risks.
• Ensure timely and complete data entry by sites in EDC or other required systems.
• Send updates and updated study core documents to study site personnel.
• Provide logistics support in sample management and tracking, where applicable, and in study supply management.
• Support investigators and staff in local submissions according to regulatory and IRB/IEC requirements.
• Assist in data review (site-level data review, resolutions to queries), facilitate database closure and freezing procedures per study plans.
• Assist with study tracking via CTMS or sponsor-designated systems to ensure reporting is current and complete.
• Document site and sponsor interactions in a timely and professional manner.
• Assist in remote review of the electronic Investigator Site File where applicable.
• Assist with Investigational Product accountability where applicable.
• Consult with project team members regarding study site issues.
• Provide quality review of amended site-level informed consent templates.
• Follow up with sites on trial invoices and ensure CTMS is updated for timely Investigator Payments.
• May attend site visits to ensure sponsor and investigator obligations are met and compliant with regulatory requirements; may mentor an In-house CRA Trainee.
• Performs other duties as assigned by management and ensures tasks are conducted per ICH-GCP, SOPs, project plans, study processes and regulatory requirements.

Qualifications

• Bachelor's degree / international equivalent or equivalent combination of education and experience in a business, scientific or healthcare discipline.
• Minimum of 2 years of relevant experience as a CRA or In-House CRA.
• Strong experience in oncological clinical trials.

Other Requirements

• High proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).
• Customer service demeanor; demonstrate flexibility and teamwork.
• Attention to detail with high accuracy.
• Fluency in English (spoken and written).
• Working knowledge of the drug development process.
• Ability to travel as needed.

Preferred

• Solid experience in clinical research or related fields.
• Excellent organizational skills.
• Ability to work efficiently in a remote work environment.
• Good knowledge and utilization of ICH-GCP, Precision SOPs, and regulatory guidance.
• Strong interpersonal, written and verbal communication skills; self-motivated and able to work independently or in a team.
• Ability to deliver on commitments and maintain professional standards in line with Precision Principles.

Statements

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or need an alternative method for applying, you may contact Precision Medicine Group at [e-mail].