FSP is a global leader in clinical research services, committed to developing breakthrough treatments to address the world’s most challenging health concerns. Our team, which powers the renowned PPD® clinical research portfolio, brings high levels of scientific and clinical expertise. By partnering with leading organizations, FSP is at the forefront of clinical trials that contribute to advancing medical innovations.
Responsibilities in Job
As an FSP Clinical Trial Coordinator I, you will play a crucial role in supporting the project team and facilitating smooth site activation for clinical trials. Key responsibilities include:
- Providing administrative and technical support to the project team.
- Reviewing internal, country, and investigator files to ensure compliance and audit readiness.
- Assisting in the timely processing and organization of essential trial documents within the electronic Trial Master File (eTMF).
- Coordinating the distribution of non-clinical study materials, such as Investigator Site Files (ISF) and Pharmacy binders.
- Maintaining study-specific documentation, tracking project activities, and supporting regulatory submissions.
- Collaborating with internal departments to align site start-up activities with the project timeline and addressing any risks or site issues.
Qualifications
To be considered for this position, candidates should meet the following qualifications:
- A Bachelor’s Degree in Life Sciences is preferred.
- 1-3 years of experience in a Clinical Research Coordinator (CRC) or Clinical Trial Coordinator (CTC) role.
- Familiarity with clinical research regulations, including ICH Good Clinical Practices (GCP).
- Excellent English communication skills, both oral and written.
- Strong knowledge of electronic Trial Master File (eTMF) systems.
Skills
The ideal candidate should possess the following skills:
- Strong organizational skills with a high level of attention to detail.
- Ability to manage multiple tasks efficiently and work both independently and as part of a team.
- Solid proficiency in MS Office (Word, Excel, PowerPoint) and the ability to master clinical trial databases.
- Proven customer service orientation and the ability to manage risk effectively.
- Good interpersonal skills and judgment, enabling you to navigate regulatory environments and support global feasibility processes.
- Experience in site capacity management and clinical trial coordination will be a plus.
