CRA II - Ukraine
Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority. Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
The Clinical Research Associate will perform clinical trial monitoring activities in compliance with trial protocol, ICH-GCP/ISO 14155, applicable local laws and regulations, company policies, and quality standards.
The Clinical Research Associate will manage study-site activities to ensure collection of accurate clinical data within prescribed timelines; identify, resolve, mitigate, and escalate risks and issues; take responsibility for multiple studies; and work independently with team support.
You’ll be accountable for:
Delivering high-quality, timely monitoring reports for sponsor approval per Clinical Monitoring Plan timelines.
Scheduling site visits for monitoring as required by protocol monitoring visit windows.
Ensuring the validity, correctness, and completeness of clinical data reviewed and collected at assigned sites as dictated by trial protocol, ICH-GCP/ISO 141155, and customer requirements.
You’ll be responsible for:
Monitoring data — remotely, on site, and via other approved modes — with a focus on data integrity and patient safety, in accordance with specific country regulations.
Planning day-to-day activities for study monitoring and setting priorities by site.
Preparing for and conducting qualification, study initiation, interim monitoring, and close-out visits at investigator sites.
Working with the line manager and CM to ensure that visit metrics are maintained as required.
Gauging the quality of clinical deliverables and addressing quality issues with team members.
Providing accurate and timely trip reports and records of hours worked.
Managing query resolution with study sites and Premier Research data management operations.
Maintaining the project tracking system of subjects and site information.
Participating in Investigators’ Meetings as assigned by Project Managers.
Maintaining contact with investigator sites via telephone calls between visits.
Ensuring adherence to study timelines and budgets.
Identifying and escalating potential risks and identifying retraining opportunities for site study teams.
You’ll also contribute by:
Being a resource for other CRAs, mentoring CRA's as appropriate and sharing knowledge and best practices.
Participating in training offered to increase therapeutic knowledge and keeping current with regulations and FDA guidance.
In specific countries or situations, assuming country-specific responsibilities and/or being named a subject-matter expert in one or more areas; e.g.: start-up, regulatory, site contracts, office management.
Assuming additional duties on certain projects, such as clinical management for smaller or less complex studies.
Experience and Qualifications:
Bachelor’s Degree or equivalent experience required
Previous on-site monitoring experience with all types of site visits is required
Working knowledge of FDA Guidance Documents / EU Directives / local regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures
Ability to multitask and work effectively in a fast-paced environment with changing priorities
Strong verbal and written communication skills
Fluency in written and verbal Ukrainian and English is mandatory. Any other language is a bonus.
Excellent organizational and time-management skills, able to meet deadlines
Self-starter with lots of common sense and able to act on own initiative
Accountable, dependable and strong commitment
Applies clear and consistent performance standards and handles problems decisively and objectively
Customer service focused in approach to work, both internally and externally
Maintains a positive, results orientated work environment
Travel requirement up to 75-80%
You must be eligible to live and work in Ukraine in order to apply for this role