In-House Clinical Research Associate (Poland)
WFA Digital Insight
The demand for remote clinical research professionals has surged in recent years, with a 25% increase in job openings in 2025 alone. As the pharmaceutical industry continues to shift towards decentralized clinical trials, the need for skilled Clinical Research Associates has never been more pressing. Alimentiv is at the forefront of this change, and this In-House Clinical Research Associate role offers a unique opportunity to work with a cutting-edge company. With the rise of remote work, candidates with strong digital skills and experience in clinical trial management are in high demand. Before applying, candidates should be aware of the importance of regulatory compliance, data management, and stakeholder collaboration in this role.
Job Description
About the Role
The In-House Clinical Research Associate role at Alimentiv is a critical position that supports and observes clinical site monitoring services in-house. As a key member of the clinical trial team, you will be responsible for providing monitoring and site management activities for full-service studies, ensuring compliance with protocol, SOP, and regulatory requirements. Your day-to-day activities will involve collaborating with investigative sites, managing data, and overseeing site performance.The clinical trial industry is rapidly evolving, with a growing emphasis on decentralized trials and remote monitoring. As a Clinical Research Associate, you will play a vital role in ensuring the success of these trials, working closely with site teams, sponsors, and regulatory agencies. Your expertise in clinical trial management, data analysis, and regulatory compliance will be essential in driving the success of Alimentiv's clinical trials.
You will be working as part of a dynamic team, reporting to the Clinical Operations Lead, and collaborating with other stakeholders, including project managers, data managers, and quality assurance specialists. Your strong communication and interpersonal skills will be critical in building strong relationships with site teams, sponsors, and regulatory agencies.
What You Will Do
- Conduct remote data review, support data query and closure activities, and perform remote activities for investigational sites in accordance with corporate, sponsor, and regulatory standards
- Manage site-specific documents, including creation, review, and filing of essential documents in the Trial Master File (TMF)
- Assist Clinical Research Associates with preparation for site visits, including running reports, QC of files, and checking for missing documents
- Perform Case Report Form review, query generation, and resolution against established data review guidelines and the monitoring plan
- Monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA
- Assist with the coordination of study visits, shipment of study supplies, and system access or updates
- Manage sites to ensure compliance with protocol requirements, study visits, and data entry timelines
- Liaise with the project team and others to distribute and track clinical trial supplies, ensuring that sites have sufficient supplies to continue recruitment
- Assist in submissions and notifications to Ethics Committees and Regulatory Authorities
- Support patient recruitment, providing guidance to site teams on inclusion/exclusion criteria
What We Are Looking For
- Undergraduate university degree (Bachelor or Honors Bachelor) in a related field, such as life sciences, nursing, or pharmacy
- 1-3 years of experience in clinical trial management, preferably in a pharmaceutical or biotechnology company
- Strong knowledge of clinical trial regulations, including ICH GCP, and regulatory requirements
- Experience with electronic data capture (EDC) systems, clinical trial management systems (CTMS), and other relevant software
- Excellent communication, interpersonal, and problem-solving skills
- Ability to work independently and as part of a team, with a strong focus on collaboration and communication
- Strong attention to detail, with excellent organizational and time management skills
- Ability to travel, as required, for site visits and other business purposes
Nice to Have
- Experience with decentralized clinical trials and remote monitoring
- Knowledge of multiple EDC systems and CTMS
- Certification in clinical trial management, such as CCRA or CCRP
- Experience with quality assurance and auditing
Benefits and Perks
- Competitive salary and benefits package
- Opportunity to work with a cutting-edge company in the pharmaceutical industry
- Collaborative and dynamic work environment
- Professional development and training opportunities
- Flexible working hours and remote work arrangements
- Access to the latest technology and tools
- Recognition and reward for outstanding performance
- Comprehensive health and wellness program
- Generous paid time off and holiday entitlement
How to Stand Out
- Develop a strong understanding of clinical trial regulations, including ICH GCP, and regulatory requirements to stand out in this role
- Create a portfolio of your experience in clinical trial management, including examples of successful trials and challenges overcome
- Highlight your ability to work independently and as part of a team, with a strong focus on collaboration and communication
- Be prepared to discuss your experience with EDC systems, CTMS, and other relevant software, and how you have applied them in previous roles
- Research Alimentiv's company culture and values to demonstrate your enthusiasm for the company and the role
- Prepare examples of how you have managed site performance, implemented action plans, and ensured compliance with protocol requirements
- Don't be afraid to ask questions during the interview process, such as what a typical day looks like in this role or what opportunities there are for professional development
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