Oferty pracy: quality control specialist

About this role:

The In-House Clinical Research Associate (also known as Trial Operations Clinical Research Associate, T-CRA) supports the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO’s mission of building a world class shared clinical technology, process innovation and clinical operations team, in partnership with the company’s divisions, through technology enablement, high-touch customer service, study acceleration, and high-quality data collection.

Driving principles and behaviors for this role are caring, diversity, global collaboration, high performance, meaningful innovation, winning spirit.

Location: Madrid (preferred), Milan or any BSC hub

This role has a hybrid work model.

Through coordination with the Contract & Budget team, and collaboration with divisional and regional clinical teams, the T-CRA conducts clinical trial site start-up activities related to the preparation and approval of regulatory documents, ensuring they are conducted consistent with service level agreements, legal and regulatory standards, and applicable company policies and procedures. Specifically, these activities will include:

• Ethics Committee (EC) submissions and approvals.
• Site informed consent form (ICF) customizations & negotiations.
• Essential regulatory document collection.
• Collaboration with Regulatory Affairs for Competent Authority (CA) submissions and approvals and other site start-up support activities, as applicable.

The T-CRA also provides support in enrollment, follow-up, and closure of clinical trial activities.

Your responsibilities will include:

• Work independently and proactively to coordinate all necessary activities for site regulatory submissions and essential document collection for allocated clinical research sites.
• Manage multiple sets of essential regulatory documents across several studies and division portfolios.
• Partner with clinical sites and or Ethics Committees and BSC Legal Department to support the negotiation and customization of Informed Consent Form (ICF)
• Develop and foster clinical research site relationships to become a subject matter expert in the site start up regulatory process across multiple studies.
• Leverage knowledge of site regulatory processes and division priorities to meet clinical study goals and objectives.
• Manage to achieve target IRB/EC timelines by assisting clinical research sites with the application submission process and approval tracking.
• Manage and problem solve site start up challenges that arise to mitigate impact to service level agreement and study goals.
• Develop, prepare, complete and track required regulatory, ICF and legal documentation.
• Document clinical research site and investigator readiness for participation across multiple studies
• Support internal quality audits, regulatory inspections, as applicable.
• Update and maintain study-specific startup and close out trackers.
• Update and maintain site specific metrics in Clinical Trial Management Systems, file and maintain site documents in eTMFs.
• Provide updates to leadership on site start up activities, investigator readiness, regulatory submission, approval status, etc.
• Escalate challenges and/or initiate outreach to Principal investigators, clinical research site coordinator, divisional clinical study leads and/or other stakeholders when appropriate.
• Ensure compliance with appropriate regulatory requirements (ICH/GCP, MDR, GDPR, etc.) and internal SOPs/WI, policies & procedures.

What we are looking for in you:

Minimum Qualifications

• Bachelor’s Degree, or an equivalent combination of experience and education.
• Background with Submitting Studies to the Ethics Committee in Italy
• Fluency (written and spoken) in English, Italian a 3rd language will be a plus and highly considered.
• Ability to multi-task: support several studies and/or personnel simultaneously, work in a very fast-paced environment.
• Ability to work in a team environment and possess clear, concise communication & presentation skills – written and verbal.
• Must be comfortable interacting with clinical research site personnel via phone and email.
• Experience working with clinical trial management systems (e.g., Siebel CTMS, Veeva) and clinical document control systems / eTMF.

Preferred Qualifications

• Research Coordinator or In-House Clinical Research Associate / Clinical Research Associate (monitor)/Study Start up specialist experience.