--- title: 'Sr. Clinical Research Associate (Romania) at Alimentiv' canonical: 'https://feeny.ai/job/sr-clinical-research-associate-romania-alimentiv-bucharest-sy8kd5pg9g4e' type: 'job' last_seen: '2026-09-13' --- # Sr. Clinical Research Associate (Romania) at Alimentiv - **Company:** Alimentiv - **Location:** Bucharest, Romania - **Compensation:** RON 200k–RON 250k - **Employment:** full-time - **Work type:** remote - **Posted:** 2026-03-13 - **Last confirmed live:** 2026-09-13 - **Apply:** https://jobs.lever.co/alimentiv-2/21cb994c-2786-4abb-9419-079b99cae778 ## Job description Independently performs, coordinates and oversees all aspects of the clinical site monitoring services, assessing protocol and regulatory compliance as per Alimentiv’s and sponsor’s standard processes, ICH/GCP guidelines and local regulation. Serves as the primary liaison between the sponsor/Alimentiv and investigative sites by playing a critical role in the execution of clinical study plans. Provides guidance and mentoring CRA I and II, collaborating effectively with cross-functional stakeholders in a dynamic, results-driven and high-accountability environment. Perform CRA Assessment Visits and participate in audits/inspections, when required. Site Monitoring activities (55-60%) - Independently conduct and document onsite and remote activities, including site monitoring and close-out visits. Ensure that all activities are documented in accordance with applicable SOPs and study guidance. - Collaborate with site staff to review and ensure that the data reported in the applicable study system(s) is consistent with the source documents and compliant with study requirements. - Monitor, resolve and/or facilitate resolution of data queries and escalate issues as appropriate. - Coordinate the shipment of clinical supplies, including but not limited to, investigational product, laboratory supplies, ePROs and study documents. - Ensures site staff is trained in all aspects of the study including but not limited to the protocol, study plans, systems and ICH-GCP. - Participate in routine study progress meetings, teleconferences, and Investigator’s meetings. - Routinely review ISF and TMF for accuracy, timeliness, and completeness. Request documents from the site, as required. Site Management activities (15-20%) - Act as a primary contact for any questions or issues that arise from investigational sites. - Oversee overall integrity of the study and promote positive working relationships with the site staff and study team members. - Facilitate and support site staff with access to study systems and ensure sites are compliant with project specific training requirements. - Ensure all site related issues are followed until resolution, including action items and protocol deviations. - Coordinate delivery of clinical sites communications, collaborating with project teams, to ensure investigational sites are provided accurate ongoing data, updates, information and feedback on project/regulatory guidelines and objectives throughout the project lifecycle. - Regularly review the study related systems remotely to ensure compliance, accuracy and completeness. - Translate site documents for TMF filing when applicable. - Routinely review the TMF for accuracy, timeliness, and completeness. Request documents from the site, as required. - Coordinate the shipment of clinical supplies, including but not limited to, investigational product, laboratory supplies, ePROs and study documents. - Participate in audits/inspections and follow-up on issues and implement actions, when required. - Participate in routine study progress meetings and teleconferences. Site Recruitment and Setup (15-20%) - Identify and advise on site investigators selection, independently conduct and document onsite and remote activities, including site qualification and initiation visits. Ensure that all activities are documented in accordance with applicable SOPs and study guidance. - Coordinate the shipment and delivery of clinical supplies, including but not limited to laboratory supplies, study documents and investigational product. - Responsible for all site management activities related to site activation and work with the sites to meet clinical project timelines and milestones. - Support the study Start-up team by following up on pending documents, as needed. - Support the Regulatory team by reviewing, localizing and translating site documents, as required. - Optimize patient recruitment providing guidance and support to site teams to meet the site recruitment milestones. - Participate in Investigator’s meetings. Mentoring and Internal Initiatives (5-10%) - Mentor and support CRA I and II. - Perform CRA Assessment Visits, co-monitoring visits or visit sign-off process, providing feedback. - Assist the MSM hiring Manager by participating in interviews with candidates for the CRA position, as requested. - Participate in process improvement initiatives and contribute to the development of best practices. ## Qualifications ## MINIMUM EXPERIENCE REQUIREMENTS 4 - 6 years of related experience ## PREFERRED EXPERIENCE REQUIREMENTS 7 – 9 years of related experience ## MINIMUM EDUCATION REQUIREMENTS (Honors) Bachelor’s degree ## PREFERRED EDUCATION REQUIREMENTS Master’s degree ## LANGUAGE REQUIREMENTS Fluent in written and verbal English Or an equivalent combination of education and experience may be considered. Working Conditions - Home-based - Regular travel is required ## ADDITIONAL KNOWLEDGE / SKILLS - Health Sciences, Life Sciences, Pharmacy or Nursing degree preferred, or Sr.CRA and/or ACRP Certification/Designation. - Experience with Phase I–IV clinical trials is preferred. - Thorough knowledge of ICH-GCP and local regulatory requirements. - Proficient in using EDC systems (e.g., Medidata Rave, Oracle InForm), IRT, eTMF, CTMS, and Microsoft Office Suite. - Ability to travel up to 40-60%, depending on project assignment and geographic location of sites. - Strong interpersonal and problem-solving skills; able to work independently and within cross-functional teams. - Great communication and organizational skills, detailed orientation and sense of urgency are required. - Holder of a valid driver’s license. Stay Alert to Recruitment Scams We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding. ## About Alimentiv ## Company Overview - **One-liner**: Alimentiv is a global, specialized gastrointestinal (GI) contract research organization (CRO) that provides full‑service clinical trials, advanced medical imaging, and precision medicine solutions to accelerate the development of GI therapies. - **Entity Type**: Private (owned by Alimentiv Health Trust, a profit‑with‑purpose trust) - **Headquarters**: London, Ontario, Canada - **Founded**: 1986 (originally as part of Robarts Research Institute; rebranded to Alimentiv in 2020) - **Founders**: Not publicly available (the organization evolved from academic GI research at Robarts Research Institute) ## Core Business - **Primary industry**: Pharmaceutical contract research (CRO), specifically gastrointestinal diseases - **Target customers**: B2B – pharmaceutical and biotechnology companies developing therapies for GI indications (e.g., IBD, celiac disease, eosinophilic esophagitis) - **Mission/purpose**: To advance the science of gastrointestinal diseases by designing and executing better, more efficient trials, generating quality data that bring pivotal GI products closer to patients [alimentiv.com](https://alimentiv.com/about-us/) ## Products & Services Alimentiv offers a comprehensive, end‑to‑end suite of GI‑focused clinical development services: - **Clinical Trial Services**: Full‑service study management, site selection (5,000+ sites in 60+ countries), medical monitoring, and clinical operations. - **Medical Imaging Solutions**: Proprietary platforms including Notō and Lucidity™, central reading for endoscopy, MRE/MRI, intestinal ultrasound (IUS), and AI‑powered tools (DovaVision™ UC, PathwaysGI, IAG). - **Precision Medicine / Biomarkers**: Biomarker analysis, spatial biology, and real‑world evidence services. - **Histopathology & Laboratory Services**: Delivered via AcelaBio, a wholly owned specialty lab offering histopathology and precision medicine for clinical trials. - **Statistics & Data Sciences**: Biostatistics, clinical data management, and medical writing. - **Clinical Pharmacology**: Pharmacokinetic/pharmacodynamic support. ## Market Standing - **Valuation**: Not disclosed (privately held by Alimentiv Health Trust) - **Key Metric**: Annual revenue of $75 M (estimated, per LinkedIn) [linkedin.com](https://linkedin.com/company/alimentiv) - **Notable Investors/Partners**: Alimentiv Health Trust (parent); partnerships with academic centers, imaging societies (IBUS), patient advocacy groups (Crohn’s & Colitis Foundation, Beyond Celiac, EUREOS), and industry consortia (STAR, CDISC Platinum Member). - **Growth Signals**: - Headcount of 507 employees (+13.9% YoY, +81 people) [linkedin.com](https://linkedin.com/company/alimentiv) - Trusted for over 70% of IBD compounds in development globally - Recent expansion into Australia and Latin America (2024) - AI imaging partnerships and new modalities (MRE/MRI, IUS) launched in 2022‑2023 ## Competitive Advantages - **Deep GI specialization**: 30+ years of exclusive focus on gastrointestinal diseases, with deep scientific and operational expertise. - **Proprietary imaging technology**: Advanced central reading platforms (Notō, Lucidity™) and AI‑driven tools that are widely adopted in GI trials. - **Global site network**: 5,000+ GI‑experienced sites across 60+ countries, enabling seamless multi‑regional studies. - **Profit‑with‑purpose ownership model**: Alimentiv Health Trust reinvests profits into research, technology, and employee benefits, creating a long‑term, mission‑driven structure. - **End‑to‑end capabilities**: From clinical management to imaging, biomarkers, histopathology, and statistics – all under one roof. ## Strategic Focus - **Innovation in GI trial design**: Developing validated endpoints, novel imaging biomarkers, and AI‑powered diagnostics. - **Expansion of precision medicine**: Growing histopathology and biomarker services (AcelaBio) and spatial biology offerings. - **Geographic expansion**: Building presence in Asia‑Pacific, Latin America, and Europe to support global trials. - **Partnership development**: Deepening collaborations with academic consortia, patient advocacy groups, and technology partners. ## Why Work Here - **Culture**: Described as “profit‑with‑purpose” – commercial success is channeled back into scientific research, technology, and employees. Employees can become beneficiaries of the Alimentiv Health Trust. - **Work environment**: Flexible and remote work options available for many roles; policies include flexible summer hours, a December holiday shutdown, and “working while visiting” programs. - **Compensation & benefits**: Industry‑benchmarked salaries, performance‑based incentives, retirement/savings plans, comprehensive health/dental/vision, generous paid time off, and parental leave. - **Engineering & science culture**: Focus on “clinical trial excellence” with opportunities to work on the most important GI studies globally. Teams include data sciences, clinical operations, imaging, and biostatistics. - **Social & inclusion**: Employee‑led social committee, virtual and in‑person regional events, and a collaborative, inclusive atmosphere. ## Sources 1. [alimentiv.com – About Us](https://alimentiv.com/about-us/) 2. [alimentiv.com – Careers](https://alimentiv.com/careers/) 3. [linkedin.com – Alimentiv Company Page](https://linkedin.com/company/alimentiv) 4. [alimentiv.com – Global Reach](https://www.alimentiv.com/about-us/global-reach/) 5. [jobs.lever.co – Alimentiv Open Roles](https://jobs.lever.co/alimentiv-2) ## Other roles at Alimentiv - [TMF Coordinator](https://feeny.ai/job/tmf-coordinator-alimentiv-warsaw-bj42h6xntqad) — Warsaw, Poland - [TMF Coordinator](https://feeny.ai/job/tmf-coordinator-alimentiv-london-dy3evtr4zgy8) — London, United Kingdom - [Join our Talent Pool - Sr Clinical Research Associate (Croatia)](https://feeny.ai/job/join-our-talent-pool-sr-clinical-research-associate-croatia-alimentiv-zagreb-0d8qrwbdyjzd) — Zagreb, Croatia - [Join our Talent Pool - Sr Clinical Research Associate (Serbia)](https://feeny.ai/job/join-our-talent-pool-sr-clinical-research-associate-serbia-alimentiv-belgrade-kjenabgdz27h) — Belgrade, Serbia - [Sr Clinical Research Associate (South Africa)](https://feeny.ai/job/sr-clinical-research-associate-south-africa-alimentiv-johannesburg-g50zhwdewkr9) — Johannesburg, South Africa - [Imaging Clinical Project Manager (1 -Year Limited Term)](https://feeny.ai/job/imaging-clinical-project-manager-1-year-limited-term-alimentiv-london-6rhrkbc9xfkg) — London, United Kingdom - [Join our Talent Pool - Sr Clinical Research Associate (Portugal)](https://feeny.ai/job/join-our-talent-pool-sr-clinical-research-associate-portugal-alimentiv-lisboa-46mx78pmjtpn) — Lisboa, Portugal - [Senior Proposal Specialist](https://feeny.ai/job/senior-proposal-specialist-alimentiv-london-fd452a49yrnk) — London, United Kingdom - [Medical Writer](https://feeny.ai/job/medical-writer-alimentiv-toronto-wvyyv7yewj6q) — Toronto, Canada - [ERP System Administrator (Acumatica)](https://feeny.ai/job/erp-system-administrator-acumatica-alimentiv-adelaide-4742ccm08bzn) — Adelaide, Australia