Location: Brussels, Belgium - home/office based
Schedule: Full-time, permanent
CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Project Coordinator. You will be responsible for supporting Project Managers on assigned projects and for performing regulatory submissions while working on projects from our varied client base, ranging from small to mid-sized pharma, biotech and medical device companies.
Join our team and help us deliver clinical trials that will improve patients lives.
Main Job Tasks and Responsibilities:
- Manage and coordinate assigned clinical projects under the supervision of the Project Manager
- Manage all project specific services required by the Sponsor (centralized lab exams, drug shipments, documents shipment, etc.)
- Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators under the supervision of the Project Manager
- Keeps him/herself professionally abreast of all scientific, regulatory and operative aspects relevant to the clinical projects he/she will be assigned
- Should be knowledgeable, following appropriate trainings, in the application process for clinical studies, in force in the country(ies) of work. Accordingly he/she can be required to provide updates on the topic, whenever relevant
- Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.)
- Collaborate with the Clinical Trial Administrators/Clinical Research Associates in terms of local authorities approval activities
- Collaborate with the CTAs in archiving activities
- Organize and participate in Monitor's and Investigator's Meetings
- Take part in the periodic project update meetings
- Inform Project Manager about any issues
- May perform co-monitoring visits for the assigned clinical projects
- Carry out, after appropriate and documented training/past experiences, the monitoring of the sites for the assigned projects, when requested and if applicable
- May acts as Feasibility Associate (FEA) after appropriate and documented training
Education, Skills and Experience:
- University Degree in scientific, medical or paramedical disciplines
- Previous experience in the clinical research industry, in either a CRA or project coordination function
- Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements
- Experience in performing submissions to Ethics Committees and Competent Authorities is desirable
- Advanced in English and local language(s)
- Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
- Willingness to travel
Our Benefits in Belgium:
- Group and hospitalization insurance
- Electronic meal vouchers
- Internet reimbursement
- Excellent work-life balance
- Full performance and development process with end of year reviews
- Team events and end of year party
- Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
- Employee satisfaction survey - your feedback is important for continuous improvement
The Application Process
Once you have submitted your CV, you will receive an acknowledgement email. If you have the requirements we need, you will be invited for phone interview as the first step.
Who will you be working for?
CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.
Our Company Ethos
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.
CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
Key words: Project Coordinator, Junior Project Manager, Associate Project Manager, Associate Study Manager, Junior Study Manager, PC, PM, CTA, Submissions, Ethics, CRA, CRO, Contract Research Organisation
Associate Project Manager