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Alimentiv
Alimentiv
201 – 500 Angajați
Asistență medicalăConsultanțăLogistică
Alimentiv este o organizație specializată de cercetare clinică pe bază de contract, care deservește domeniile bolilor gastrointestinale și hepatice. Compania combină managementul studiilor clinice, operațiunile centrelor de studiu, sprijinul de reglementare, medicina de precizie și imagistica medicală avansată pentru a contribui la dezvoltarea terapiilor gastrointestinale. Cu o experiență de peste trei decenii, Alimentiv operează printr-o rețea globală de specialiști medicali și operaționali din peste 60 de țări, oferind servicii de cercetare clinică, informații bazate pe biomarkeri și capacități de imagistică ce sprijină desfășurarea studiilor și recrutarea pacienților.
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Senior Clinical Research Associate – Serbia (Remote)

Senior Clinical Research Associate overseeing gastrointestinal clinical trial monitoring across Serbia and Croatia. The role supports site compliance, recruitment, study documentation, and CRA mentoring at Alimentiv, a global CRO.

RSSerbiaRemoteNormă întreagăSeniorLimbă Obligatorie: englezăCercetare clinică
Google Cloud PlatformOracle

Descriere

  • Independently perform and document onsite and remote monitoring activities, from site qualification and initiation through monitoring and close-out visits across Serbia and Croatia
  • Verify that investigative sites follow study protocols, ICH-GCP, relevant regulations, SOPs, and project requirements
  • Serve as the primary contact for assigned sites, addressing questions, issues, action items, and protocol deviations
  • Assess clinical trial data, source records, and study systems for accuracy, completeness, integrity, and compliance
  • Assist with site selection, activation, recruitment, study milestones, and patient enrollment targets
  • Train site personnel on study protocols, systems, procedures, and applicable requirements
  • Keep essential trial records current, including the Investigator Site File and Trial Master File
  • Coordinate with sponsors, project teams, vendors, and investigative sites
  • Take part in audits, inspections, Investigator Meetings, study meetings, and other project activities
  • Coach CRA I and CRA II colleagues, support co-monitoring and CRA assessments, and help improve processes

Cerințe

  • Bachelor’s degree with Honours in life sciences, health sciences, pharmacy, nursing, or a related field
  • Four to six years of relevant clinical research experience
  • Substantial experience monitoring clinical sites from start-up through close-out
  • Detailed knowledge of ICH-GCP, clinical research practices, and applicable local regulations
  • Working proficiency with EDC, IRT, eTMF, CTMS, and Microsoft Office
  • Strong capability in site management, including activation, recruitment, training, issue resolution, and essential documentation
  • Excellent communication, interpersonal, and relationship-management abilities
  • Well-developed organisation, problem-solving, and prioritisation skills
  • Capacity to work independently, apply sound judgement, and manage competing demands
  • Availability and ability to travel approximately 40–60%
  • Valid driver’s licence
  • Fluent written and spoken English
  • Experience with Phase I–IV trials, Medidata Rave or Oracle InForm, and mentoring junior CRAs is preferred

Beneficii

  • Education reimbursement program for full-time employees
  • Monthly mobile phone and remote-work allowance, subject to role eligibility
  • One-time office setup allowance for items such as a scanner, printer, additional monitor, or office furniture
  • Working While Visiting program allowing up to four weeks per year
  • Flexible Summer Hours Program from May through September
  • Employee referral incentive
  • Full-time employees become beneficiaries of the Alimentiv Trust after one year and permanent members after five years
  • Optional Alimentorship formal mentoring program
  • Annual in-person social events at the country or regional level
  • Leadership development programs for people leaders based on seniority
  • Social committee and other optional initiatives
  • Additional benefits may apply according to the employment country, local policies, and eligibility

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