study start up specialist - halandri

Do you hold a life science degree and have work experience, in clinical research? Is your experience in clinical development or start up/regulatory process as a Study start up specialist?

Great news for you, we are looking for a Study start up specialist to become the member of a leading CRO.

If you want to build a solid work experience and win an exciting career opportunity  as a Study start up specialist, please apply now!

The company offers the following benefits for this Study start up specialist role:

• Competitive remuneration package
• Dynamic working environment, focused on company’s values

The Study start up specialist we are looking for will be responsible for preparing all the documentation necessary for the submission of clinical studies to the Competent Authorities and Ethics Committees of reference, in order to obtain regulatory and ethical administrative authorization. 

Key Accountabilities

• Support Clinical Research Team with accurate updating and maintenance of clinical system that track site compliance and performance with clinical trial’s timelines
• Handle preparation, handing, distribution, filing and archiving of clinical trial documentation and reports following regulatory requirements and standard operating procedures, in close collaboration with Clinical Research Associates/ team.
• Submission management: preparation, execution, follow-up to hospital sites, National Ethics Committee and Health Authorities (all types of submissions, according to regulatory requirements and standard operating procedures) where applicable, in close collaboration with the clinical trial team (internal and/ or external)
• Contract management: preparation, execution, follow-up to hospital sites/ institutions (YPEs/ Universities/ Private) and local vendors
• Payments management: execution of payments and follow-up until deposits to vendors’/ investigator’s/ institutions’ bank accounts (all types of payments)
• Perform accounting actions (i.e., Goods Receipt, accruals, provisions) in the system whenever a service is provided and ensure proper phasing and reporting of costs monthly respecting timelines provided by finance department
• Vendor management: ensure appropriate documentation is in place for vendor selection/ management following standard operating procedures/ guidelines and maintain documentation in the vendor management system
• IMP handling: assist clinical research associate with timely order, preparation, handling, relabeling and distribution of clinical trial supplies and maintenance of the relevant tracking information. Handle communications with sites and local depot, whenever required
• Filing management: preparation and maintenance of binders for Trial Master Files and Investigators Folders. Arrange transfer of Trial Master File to central warehouse, where appropriate
• Document management system: scanning of documentation timely and with high quality. Perform quality check until completion
• Trainings: perform timely all mandatory trainings assigned to role
• Ensure Audit/ Inspection readiness and support
• Perform assigned administrative tasks to support team members with clinical trial execution

The ideal candidate for the Study start up specialist role will be expected to have the following:

• Awareness of applicable regulatory requirements i.e., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines and relevant local regulations
• Knowledge of protocol requirements as provided in company training
• Computer Literacy
• Good written and verbal communication skills in both Greek and English language

• Effective time management and organizational skills
• Interpersonal and intrapersonal qualities
• Competencies to collectively solve problems or make progress toward a common goal

At least 1 year

If this sounds like you, we want to hear from you today! Should you need additional information,  please contact me Dora Tzevelekou at 2166001387.

Please note that after the screening of all the CVs received, we will only contact the candidates who meet the requirements of the job to arrange an interview. All applications are considered strictly confidential.