Sofia, Bulgaria
Internship Explorer
Internship Explorer
A great opportunity for students eager to begin a career in Clinical Research and gain hands‑on exposure to the work of Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs). Key Responsibilities Training & Onboarding Participate in a structured onboarding program covering Clinical Research, ICH-GCP, clinical monitoring principles, and study operations. Complete assigned learning modules and attend team‑led trainings, workshops, and knowledge‑sharing sessions. Build a foundational understanding of trial phases, safety reporting, regulatory requirements, and quality expectations. CRA & CTA Role Shadowing Shadow experienced CRAs and CTAs to observe daily responsibilities and decision‑making in real study environments. Gain exposure to study monitoring, risk‑based monitoring concepts, and site relationship management. Assist with preparation for visits, follow‑up tasks, and tracking activities. Site Monitoring & Field Exposure Opportunity to observe on‑site visits of all major types, including: Site Selection Visits (SSVs) Site Initiation Visits (SIVs) Interim Monitoring Visits (IMVs) Close-Out Visits (COVs) Observe IP accountability, subject reimbursement procedures, source documentation review, and essential document checks alongside CRAs. Support reconciliation of monitoring findings and action items under supervision. Documentation & Study Management Assist with eTMF filing, document QC checks, and maintenance of trial trackers. Help prepare study materials, site communications, and newsletters. Support regulatory document collection, site staff list updates, and study file organization. Learn how to work with clinical systems such as CTMS, eTMF, and study portals. Team Collaboration Participate in Site Management team initiatives, continuous improvement activities, and internal projects. Attend team meetings, study calls, and cross‑functional discussions to gain broad exposure to clinical trial operations. Contribute fresh ideas and support process optimization activities.
