Staffing services voor de Life Sciences industrie

Clinical Research Coördinator in Leiden 32-36 uur

Clinical Operations Leiden W&S #1105

The organization

The mission of our client is to save the lives of patients with blood cancers. To strengthen their team they are seeking a Clinical Research Coordinator, a fantastic opportunity working for a great cause on the cutting edge of science in a growing organization. The organization currently counts 90 employees in Europe and the Dutch office is located in Leiden, but there is a lot of flexibility working from home.

The Position

As one of the Study Coordinators, you will manage a number of national and/or international, multi-centre (non-)interventional studies. Your job is to coordinate people and processes to ensure that the studies assigned to you are delivered on time and within the scope of the budget. You are involved in all phases of a study, from start-up to reporting.

Your responsibilities include developing detailed study plans, setting up and managing resources and timelines, collecting and maintaining essential documents, overseeing vendor services (e.g. site monitoring), organizing patient registration, designing the CRFs, organising statistical activities (e.g. interim and final study reports) and planning publications. If needed, you will also ensure that all regulatory and ethical approvals are in place at the beginning of and for the duration of the studies.

If you thrive on communicating and collaborating with others, this position will not disappoint you. As Study Coordinator, you are the primary liaison between the company and collaborating pharmaceutical companies, investigators and vendors, as well as the central contact point for your internal project team members. When the teams grows, you can also supervise more junior staff.

  • Organise and manage the day-to-day activities involved in carrying out national and international research studies (clinical, PASS, non interventional);
  • Set up and manage timelines for the studies, keeping all parties informed of progress;
  • Coordinate/manage/oversee the activities of all parties involved; oversee the preparation and negotiation of study contracts, organise and participate in meetings/conference calls (e.g. with Steering Committee, country leads, investigators, statisticians, writing committee, pharmaceutical industry), ensure compliance with contracts, GDPR, the study protocol and regulations;
  • If applicable, assist with protocol (amendment) writing and CRF design;
  • Collect essential documents and manage eTMF;
  • Prepare study plans, e.g. project management plan, risk management plan, monitoring plan, patient recruitment and retention plan, etc.;
  • Organise patient registration and monitor recruitment;
  • Oversee site and data management to yield high-quality and reliable study data;
  • Review and approve data reports (e.g. progress reports for the Steering Committee, national Ethics Committes and competent authorities, monitoring reports, statistical study reports, etc.), manuscripts and publications;
  • Perform co-monitoring visits, if applicable;
  • Draft summary reports for senior management and principal investigator meetings; attend such meetings, provide administrative support and give presentations;
  • Oversee the regulatory and ethics committee status in all countries and sites involved;
  • Assist with the on-going development and maintenance of Standard Operating Procedures, standard forms and work instructions.

Profile

  • Higher vocational education (medical/paramedical backgroud);
  • Experience within a clinical research environment, unfortunately we cannot consider junior candidates
  • Up-to-date knowledge of clinical research regulations and implications of GDPR;
  • Knowledge of medical terminology;
  • Broadly experienced in PC applications, like MS Office, SPSS;
  • Good organisational and communication skills;
  • Skilled in establishing and managing data collection;
  • Fluency in English is required.

Offer

You will be working in a great team with warm colleagues and a company with a strong goal. Besides the base salary you will for example receive a 13th month, holiday allowance, flexible hours, collective healh insurance and a pension scheme.

More information

Interested in this position? Please respond via this website. For questions, please contact Albert Hollemans via 0622639519 / albert@heraklespharma.nl. It will be appreciated to send your CV upfront.

More information about this vacancy

Albert Hollemans

Associate Director Business Development