Location: Poland - 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, and will be 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:
- Manages and coordinates the assigned clinical projects under the supervision of the Project Manager (PM)/ Senior Project Manager (SPM)
- Manages all project specific services required by the Sponsor (centralized lab exams, drug shipments, documents shipment, etc.)
- Manages the correct development of the clinical project, interacting with the Sponsor and the Investigators under the supervision of the PM/SPM
- 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
- Collects and manages study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.)
- Collaborates with the Clinical Trial Administrators (CTAs)/Clinical Research Associates (CRAs)in terms of local authorities approval activities
- Collaborates with the CTAs in archiving activities
- Organizes and participates in Monitor's and Investigator's Meetings
- Takes part in the periodic project update meetings
- Informs PM/SPM about any issues
- Performs, if necessary, co-monitoring visits for the assigned clinical projects
- Carries 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 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
- Experience in performing submissions to Ethics Committees and Competent Authorities is desirable
Specific Role Requirements and Skills:
- Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements
- Advanced in English and local language(s)
- Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
- Willingness to travel
The Benefits of Working for CROMSOURCE in Poland:
- Internet compensation of up to PLN 80 per month
- Insurances: Group Accident (employer funded), medical care and social fund (as per Polish regulations)
- PPK Pension participation (as per Polish regulations)
- Mobile phone if applicable
- Meal Vouchers
- Flexible working hours
- Occasional work from home
- Holidays: Between 20 and 26 days per year, depending on seniority
- Refund on corrective glasses for computer work (as per Polish regulations)
- Annual Christmas party
- Seniority Bonus
- Excellent work-life balance
- Full performance and development process with end of year reviews
- 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, Clinical Trials, Submissions, GCP, Medical Devices
Associate Project Manager, Project Assistant