Study Start-Up Coordinator
hace 1 día
About Novasyte
Novasyte is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.
We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world.
Job Overview
We are seeking a highly skilled Study Start-Up Specialist I/II to join our team. The ideal candidate will possess excellent communication skills, both written and verbal, as well as strong organizational and interpersonal skills.
Key Responsibilities
- Site Activation: Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual guidelines.
- Servicing as Single Point of Contact (SPOC): Serve as SPOC in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
- Maintenance Activities: Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
- Reviewing Documents: Review regulatory documents for completeness and accuracy.
- Tracking Progress: Track progress, approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
Requirements
- Bachelor's Degree: A Bachelor's degree (or equivalent), preferably in science or related field.
- Relevant Experience: 6 months - 4 years relevant experience, preferably in study start-up and maintenance activities.
- Language Skills: Strong written and verbal communication skills, including proficiency in English, both verbally and written.
Benefits
- Competitive Salary: Competitive salary package.
- Opportunities for Growth: Opportunities for growth and professional development.
- Culture: Our company culture values teamwork, innovation and excellence.
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