Senior Clinical Research Associate
4 days ago
We are seeking a highly experienced Senior Clinical Research Associate to join our specialized SRS/FSP team at TFS HealthScience. As a key member of our global team, you will play a critical role in advancing clinical trials, ensuring their quality, integrity, and success from initiation through to completion.
Key Responsibilities- Submission and Amendment Support: Lead and assist with submissions and amendments to ethics committees, ensuring the highest standards of accuracy and compliance.
- Regulatory Reporting: Oversee periodic safety and compliance reports to ethics committees, guaranteeing all regulatory requirements are met.
- Pre-activation and Site Initiation Visits (SIV): Support and contribute to site pre-activation and participate in Site Initiation Visits to kickstart trial success.
- Monitoring and Site Management: Conduct both on-site and remote monitoring to maintain trial quality; build and maintain strong relationships with site teams.
- Documentation and Closeout: Manage the electronic Trial Master File (eTMF) and lead site closeout visits, ensuring a smooth and compliant closure of the trial.
- Experience: A minimum of 5 years in clinical monitoring within CRO, biotech, or pharmaceutical environments.
- Education: Bachelor's degree in Life Sciences, Nursing, or a related field.
- Regulatory Expertise: In-depth knowledge of ICH-GCP guidelines and Swedish regulatory requirements.
- Technical Proficiency: Expertise in clinical trial management systems (CTMS) and eTMF platforms.
- Communication Skills: Strong verbal and written communication skills, with the ability to build rapport with site staff and sponsor representatives.
TFS HealthScience is a full-service, global Contract Research Organization (CRO) with over 27 years of experience in delivering tailored clinical research services. We build solution-driven teams working towards a healthier future, bringing together over 800 professionals in more than 40 countries. Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decision-making and foster a culture of mutual respect and collaboration.
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Clinical Research Associate
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Solna Municipality, Sweden TFS HealthScience Full timeTransforming Healthcare through Clinical ExcellenceWe are seeking a highly experienced Senior Clinical Research Associate to join our specialized SRS/FSP team at TFS HealthScience. As a global leader in the pharmaceutical and biotech sectors, we invite you to be part of our journey in advancing clinical trials and ensuring their quality, integrity, and...
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