Course Assistant (“Missione CRA” Training Program)

Course Assistant (“Missione CRA” Training Program)

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Job details

Work location: Mesagne (BR), hybrid or full-remote.

Schedule: Full-time.

Contract: CCNL Commercio (starting RAL €35k). The gross annual salary (RAL) will be commensurate with the experience of the selected candidate.

About us

ClinOpsHub S.r.l. was founded in 2014 by Stefano Lagravinese and, after years of providing services to various clients in the field of Clinical Research, in 2019 it was registered as a Contract Research Organization (CRO) on the AIFA website, in compliance with the requirements set out by Ministerial Decree 15.11.2011 (CRO Decree).

ClinOpsHub S.r.l. provides support services to Pharmaceutical Companies, Trial Sites, Laboratories and other CROs at national and international level, ensuring high quality standards thanks to a well-trained team of young professionals.

In view of the imminent increase in projects in the area of quality assurance for clinical trials, we plan to strengthen the Quality Assurance Department. We are therefore looking for a resource to support ClinOpsHub’s Quality Assurance Consultants in managing department projects, in accordance with company SOPs, guidelines, and national and international regulations. The selected resource will travel to customer sites and serve as a direct point of contact with them.

Main responsibilities

Maintain systems and processes in compliance with GCP.

Draft and/or revise SOPs.

Manage non-conformities and CAPA.

Promote continuous improvement of the quality management system.

Manage selection and qualification of company suppliers.

Keep the internal quality system up to date to ensure compliance with procedures, guidelines, and applicable regulations.

Report significant quality gaps and/or risks to upper management and actively participate in problem resolution.

Be present during possible inspections by regulatory bodies and external audits (by clients or ISO 9001:2015 auditors).

Perform quality checks on study documentation (ISF at the trial site and TMF at the sponsor), including study protocols, Investigator’s Brochure, informed consent forms, CRFs, etc.

Support company auditors in preparing and managing system and study-specific audits, to ensure compliance with the sponsor’s study protocols, GCP, industry guidelines, and clinical trial regulations.

Serve as a Quality Assurance Consultant for clinical sites/laboratories/sponsors and CROs, ClinOpsHub clients, providing QA consulting remotely and/or on site as agreed.

Profile and requirements

Education:

Second-cycle degree in a scientific field (preferably Master’s/PhD in Biology, Biotechnology, Pharmacy/CTF, Life Sciences, etc.).

GCP QA qualification per the requirements of Art. 3 of Ministerial Decree 15.11.2011 (“Definition of minimum requirements for Contract Research Organizations (CROs) involved in clinical trials of medicinal products”).

Available to travel.

IT skills: Good command of the Office suite (Excel, Word, Outlook).

Organization: ability to plan and manage activities effectively, meeting deadlines and optimizing resources.

Interpersonal skills: ability to communicate and collaborate within a team, fostering a positive and productive work environment.

Logical mindset: ability to analyze problems in a structured way and identify effective solutions through a methodical, rational approach.

Prioritization: ability to identify and focus on the most critical objectives, adapting flexibly to business needs.

Language: Excellent command of English.

Experience: At least 1 year of experience. Experience as QA for Phase 1 studies is a plus.

What we offer

Continuous training.
Opportunities for professional growth in a young and dynamic environment.
Company benefits.

This job advertisement is open to both men and women, pursuant to Legislative Decree of April 11, 2006 No. 198 “Code of Equal Opportunities between Men and Women,” and to people of all ages and nationalities, pursuant to Directive 2000/78/EC “Equal Treatment in Employment.” In line with the principles of inclusion, diversity, and equal opportunities, we inform you that, in the event of equal scores between candidates, priority will be given to the candidate belonging to a category currently underrepresented within our team, in accordance with our commitment to promoting diversity. xysqume

With regard to your application, ClinOpsHub S.r.l. will process personal data in compliance with the GDPR, applying the rules concerning the retention period of personal data.

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