Logo for Alimentiv

In-House Clinical Research Associate (Poland)

Alimentiv

Role overview

Qualifications

  • Undergraduate university degree (Bachelor or Honors Bachelor)
  • 1-3 years' related clinical research experience with initial and ongoing training
  • Knowledge of ICH GCP and regulatory standards/guidelines

Responsibilities

  • Site management and monitoring activities to ensure protocol, SOP, and regulatory compliance
  • Remote data review, data query resolution, and support of Risk Based Monitoring (RBM) activities
  • Assist with submissions and notifications to Ethics Committees and Regulatory Authorities (as applicable)
  • Liaise with project teams and investigative sites to coordinate site visits, study materials, patient recruitment, and TMF/document management

About the company

Alimentiv logo

Alimentiv

Pharmaceuticals

From 1986 to 2020 we operated as Robarts Clinical Trials and built a strong foundation in the medical research community. In 2020, we became Alimentiv but retained our commitment to clinical trials, medical imaging, and precision medicine for GI-related ailments.

Company details

Company typeSME
IndustryPharmaceuticals
Company size201 - 500

Links

Website LinkedIn See all jobs

Your match analysis

See how your profile stacks up against this role.

We compared the job requirements to your profile to show where you're strong and where you fall short.

Job description

This position will support and observe clinical site monitoring services inhouse and provide monitoring and site management activities for full-service studies assessing for protocol, SOP and regulatory compliance. Responsibilities include site management activities to help drive investigative sites and patient recruitment, compliance and oversight.  Conduct remote data review, support data query and closure activities, support Risk Based Monitoring (RBM) activities, assess data collection and (regulatory) document collection, perform remote activities for investigational sites in accordance with corporate, sponsor and regulatory (ICH GCP and other) standards and guidelines. Represents the corporation by maintaining collaborative relationships with stakeholders.

Site Management
  • Serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per SOPs, Monitoring Plan and study guidance, including creating contact reports for each telephone session (outbound or inbound) with sites.
  • Act as the first point of contact for site when the CRA is absent.
  • Manage and file site specific documents in (e) TMF.
  • Assist Clinical Research Associates (CRA) with preparation for site visits (i.e. running reports, QC of files and checking for missing documents in the TMF, resolving action items and queries from previous visits).
  • Perform Case Report Form review, query generation and resolution against established data review guidelines and the monitoring plan.
  • Monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.
  • Assist with the coordination of study visits, shipment study supplies and system access or updates.
  • Manage sites to ensure compliance with protocol requirements, study visits, and data entry timelines.
  • Liaise with the project team and others to distribute and track clinical trial supplies, e.g. Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.
  • Liaise with the Project Coordinator, Project Manager and or Clinical Operation Lead (COL) in the production of Status Reports.
  • Assist in submissions and notifications to Ethics Committees and Regulatory Authorities. As applicable in region.
  • Occasionally, if needed, perform remote visits (i.e. qualification, site initiation, interim and close out visits) as required by the monitoring plan, but does not perform remote monitoring that requires SDV.
  • General Monitoring Responsibilities: perform onsite visits as co-monitor if needed.
  • Supports preparation for audit and required follow-up actions.

    • Site Setup and Startup Support
  • Potentially support with identification and recruit site investigators, coordinate the movement and delivery of trial materials, samples, tests, and forms, including investigational medicinal products, protocols, SOPs, CRFs, project documents, forms, and support tools.
  • Support patient recruitment providing guidance to site teams of inclusion/exclusion criteria.

    • Training and Development
  • Support and observe primary assigned CRAs at both onsite and remote visits.
  • Support COLs with remote site management activities.
  • Participate in all study related activities, including but not limited to training, team meetings and provide any necessary updates to the study team.

    • Qualifications
  • Undergraduate university degree (Bachelor or Honors Bachelor), & 1-3 years' related experience with initial and On-going training.
    • PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report. 

    Apply once. Then go straight to the hiring manager.

    After you apply, unlock the direct contact details of the people who actually make the call. A quick follow-up makes you 5x more likely to land an interview.

    MR

    Marcus Rivera

    Chief Revenue Officer

    m.rivera@company.com
    linkedin.com/in/marcusrivera
    Unlocked after you apply
    ·

    Research Assistant Related jobs

    PolandResearch Assistant

    Other jobs at Alimentiv

    Premium

    Reach out to the hiring manager directly.

    Gain access to the contact details of the hiring managers who actually decide, and reach out to network with them directly. That, plus more when you upgrade:

    • Full match report with fit score and gaps
    • Career diagnostics on how recruiters read you
    • Curated company matches and warm intros
    • 48h early access to new roles

    Cancel anytime.