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Alimentiv

Runs clinical trials for digestive disease treatments

Senior Clinical Research Associate

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeBelgrade, SerbiaNo salary listed

About the Job

Requirements

  • A bachelor’s degree (Honours) in Life Sciences, Health Sciences, Pharmacy, Nursing or a related discipline is required.
  • Four to six years of relevant clinical research experience is required.
  • Strong clinical site monitoring experience across clinical trial activities from site start-up through close-out is required.
  • Thorough knowledge of ICH-GCP, clinical research principles and applicable local regulatory requirements is required.
  • Proficiency with clinical trial systems such as EDC, IRT, eTMF, CTMS and Microsoft Office is required.
  • A strong understanding of site management, including site activation, recruitment, training, issue resolution and maintenance of essential documentation, is required.
  • The ability to work effectively with investigative sites, sponsors and cross-functional teams is required.
  • Strong organizational, problem-solving and prioritization skills, attention to detail and a sense of urgency are required.
  • The ability to work independently, demonstrate sound judgement and manage competing priorities in a results-driven environment is required.
  • Fluent written and verbal English is required.
  • Willingness and ability to travel approximately 40–60%, depending on project requirements and geographic location, is required.
  • A valid driver’s license is required.

Responsibilities

  • Independently conduct and document onsite and remote monitoring activities, including site qualification, initiation, monitoring and close-out visits across Serbia and Croatia.
  • Ensure investigative sites comply with study protocols, ICH-GCP, applicable regulations, SOPs and project-specific requirements.
  • Serve as the primary point of contact for assigned sites, managing site-related questions, issues, action items and protocol deviations through to resolution.
  • Review clinical trial data, source documentation and study systems to ensure accuracy, completeness, data integrity and compliance.
  • Support site selection, activation and recruitment activities, working with sites to achieve study milestones and patient recruitment targets.
  • Ensure sites are appropriately trained on protocols, study systems, processes and applicable requirements throughout the study lifecycle.
  • Maintain oversight of essential study documentation, including ISF and TMF, ensuring documents are complete, accurate and filed in a timely manner.
  • Collaborate with sponsors, project teams, vendors and investigative sites to support study timelines, resolve issues and maintain effective working relationships.
  • Participate in audits and inspections, Investigator Meetings, study meetings and other project activities as required.
  • Provide mentoring and support to CRA I and II colleagues, participate in co-monitoring and CRA assessment activities, and contribute to process improvement initiatives.

Desired Qualifications

  • A master’s degree is preferred.
  • Seven to nine years of clinical research experience is preferred.
  • Experience with Phase I–IV clinical trials is preferred.
  • Experience with Medidata Rave or Oracle InForm is preferred.
  • Experience mentoring or supporting junior CRAs is preferred.

About the Company

Alimentiv

Runs clinical trials for digestive disease treatments

Alimentiv runs clinical trials for pharmaceutical and biotechnology companies developing treatments for gastrointestinal diseases. Its contract research services cover study design, site monitoring and regulatory submissions, with medical imaging used to measure how patients respond to treatment. The company combines central image reading with tissue analysis and biomarker testing through sister laboratory AcelaBio. Sponsors pay for trial execution, scientific consulting and statistical services that support drug development from early studies through regulatory review. Founded in 1986, Alimentiv is headquartered in London, Ontario, and operates internationally.

Company size
501-1,000
Company stage
Not listed
Total funding
Not listed
Headquarters
London, Canada
Founded
1986

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