**company description** we are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. a dynamic, global company founded in 1995, we bring together more than 2,800 driven, dedicated and passionate individuals. we work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information. **only cvs in english will be accepted.** **you will be responsible for**: - being the main point of contact between site personnel and cra involved in the project helping on query resolution and edc completion. - serves as the primary sites’ contact point for vendors, study supplies, and - access management. - ensure that pre-study testing (scans, mri/ct qualification questionnaires, test ecgs, etc.) of local site facilities is completed - act as the one who will ensure the order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies. - ensures regulatory and ethics committee submissions and notifications, meaning you will need to be up to date on local regulations and dispositions. - coordinate preparation for and follow-up on site, tmf and systems´ audits and inspections. - manage the tmf on a site and a country level for regularly and file documents. prepare, distribute, and update investigator site files (isf) and isf checklists. - arrange and track initial and on-going proj...
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 ...
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