SITE MANAGEMENT ASSOCIATE I VTY481

Psi-cro


Site Management Associate I PSI CRO AG Bogota, D.C., Capital District, Colombia Join our international team as a Site Management Associate I, supporting clinical research projects by streamlining communication, maintaining systems, and managing documents and information. Responsibilities include: - Acting as the main contact between site personnel and CRAs, assisting with queries and EDC completion. - Serving as the primary contact for vendors, study supplies, and access management. - Ensuring pre-study testing of local site facilities is completed. - Assisting monitors with documentation in CTMS and tracking site issues and actions. - Managing clinical supplies' order, receipt, storage, distribution, return, and reconciliation. - Handling regulatory submissions and notifications, staying updated on local regulations. - Coordinating audits and inspections. - Managing the TMF at site and country levels, including document filing and updates. - Organizing and tracking training for site teams on vendor systems. - Reviewing study documentation and translation statuses. - Ensuring proper safety information flow with investigative sites. Qualifications: - Degree in Life Sciences. - Experience in administrative roles, preferably internationally. - Experience as a CTA in CROs and in clinical research. - Knowledge of local regulations. - Proficiency in English and Spanish. - Skillful in MS Office. - Ability to work dynamically in a team and communicate effectively. Additional Information: Advance your career in clinical research by coordinating tasks and growing with the company. Details: - Seniority level: Entry level - Employment type: Full-time - Job function: Administrative - Industry: Pharmaceutical Manufacturing #J-18808-Ljbffr

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