Inhouse CRA

For one of our clients, a medical device company based in Machelen, we are looking for an enthusiastic Inhouse CRA to come on board and join the team to cover sites located in Flanders and in the Netherlands.
This position is open for bilingual candidates Dutch and English, with a first experience in clinical research. This opportunity is hybrid working : 2-3 days/week office-based at client's location in Machelen.

Job Description

The Inhouse Clinical Research Associate (Inhouse 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.

Through coordination with the Contract & Budget team, and collaboration with divisional and regional clinical teams, the Inhouse 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 - Review/adaptation of ICF
• Essential regulatory document collection - Request /collection of relevant (i.e., Regulatory Docs, CV/ML) investigator/site documentation.
• Collaboration with Regulatory Affairs for Competent Authority (CA) submissions and approvals and other site start-up support activities, as applicable.

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

Responsibilities

• Work independently and proactively to coordinate all necessary activities for site regulatory submissions, site activation 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 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. Ensure submission to Ethical committees following country/region regulations.
• 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. Authorize site to enroll when all required processes are completed, and docs collected.
• 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.
• Review and upload documents in applicable database
• Provide updates to leadership on site start up activities, investigator readiness, regulatory submission, approval status, etc.
• Participates in study-specific meetings, teleconferences, and trainings.
• Collaborates with cross-functional team members and study sites throughout all study phases.
• Participation on Audit preparation activities. Support internal quality audits, regulatory inspections, as applicable.
• 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.

Requirements

• University degree, or an equivalent combination of experience and education.
• A first experience in clinical research. Experience in study submission to the Ethics Committee (Netherlands and Belgium) is a strong asset.
• Bilingual Dutch/English. Being trilingual Dutch/English/French is an asset.
• Experience working with clinical trial management systems (e.g., Siebel CTMS, Veeva) and clinical document control systems / eTMF.
• Ability to multi-task: support several studies and/or personnel simultaneously.
• 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, email.

Benefits

• Fulltime position
• A balanced salary package based on your capabilities and experience, including extra legal benefits
• Hybrid working : 2-3 days/week home-based.

Vacancy number: 25382