CRA II - FSP, Romania
Other
WFA Digital Insight
As the demand for clinical research professionals continues to grow, with a 25% increase in job postings over the past year, skilled CRAs are in high demand. This role at Fortrea stands out for its emphasis on innovative medical advancements and flexible work arrangements. With the global clinical trials market projected to reach $68.9 billion by 2026, experienced professionals can leverage their skills to drive groundbreaking research. Before applying, candidates should be aware of the importance of staying up-to-date with ICH GCP guidelines and local regulatory requirements.
Job Description
About the Role
The Clinical Research Associate (CRA) role at Fortrea is an exciting opportunity for professionals to be at the forefront of medical advancements in various indications, including Oncology, Neurology, and Gene Therapy. As a CRA, you will play a critical role in ensuring the success of clinical trials, working closely with investigational sites to ensure compliance with protocols, regulatory requirements, and Good Clinical Practice (GCP). Your day-to-day responsibilities will involve conducting site visits, reviewing and verifying clinical data, and providing ongoing training to site staff. You will be the primary point of contact for investigational sites, ensuring smooth study operations and addressing any issues that may arise. The CRA role is a key part of the clinical trial process, and your work will have a direct impact on the development of new treatments and therapies.What You Will Do
- Conduct site visits to ensure compliance with protocols, regulatory requirements, and GCP
- Review and verify the accuracy of clinical data collected from study sites
- Provide ongoing training to site staff on study protocols and regulatory requirements
- Prepare monitoring reports, maintain study records, and contribute to overall trial documentation
- Serve as the primary point of contact for investigational sites, ensuring smooth study operations
- Conduct Source Document Verification (SDV) to ensure the accuracy of clinical data
- Collaborate with the study team to resolve any issues that may arise during the trial
- Develop and maintain relationships with investigational sites to ensure long-term collaboration
- Stay up-to-date with ICH GCP guidelines and local regulatory requirements
- Participate in investigator meetings and other study-related activities
- Develop and implement corrective action plans to address any issues that may arise during the trial
What We Are Looking For
- Life Sciences University degree or certification in a related allied health profession
- Thorough understanding of ICH GCP Guidelines and local regulatory requirements
- Thorough knowledge of monitoring procedures and basic understanding of the clinical trial process
- Fluency in Romanian and English, both written and verbal
- Relevant experience in clinical research, preferably as a CRA
- Strong communication and interpersonal skills
- Ability to work independently and as part of a team
- Strong attention to detail and organizational skills
- Ability to travel to investigational sites as required
Nice to Have
- Experience with electronic data capture (EDC) systems
- Knowledge of regulatory requirements for clinical trials in Romania
- Experience with project management tools and software
- Certification in a related field, such as CCRA or ACRP
Benefits and Perks
- Flexible work arrangements, including remote and hybrid options
- Career growth opportunities in a supportive environment
- Dedicated Line Manager to provide guidance and support
- Opportunity to work on innovative studies with a leading sponsor
- Attractive salary and benefits package
- Opportunities for professional development and training
- Collaborative and dynamic work environment
How to Stand Out
- Ensure you have a thorough understanding of ICH GCP guidelines and local regulatory requirements before applying.
- Highlight your experience with clinical trials and monitoring procedures in your application.
- Develop a strong portfolio that showcases your skills and experience as a CRA.
- Be prepared to discuss your experience with electronic data capture (EDC) systems and other clinical trial software.
- Research the company and the specific role to understand the company culture and values.
- Practice your communication and interpersonal skills, as these are critical for success in this role.
- Be prepared to discuss your experience with project management tools and software.
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