WPISZ SŁOWA KLUCZOWE

Clinical Research Coordinator

Clinical Research Coordinator
Miejsce pracy: Gdańsk

Medicover Integrated Clinical Services (MICS) is a specialised business unit with the objective to help bring innovative therapies and diagnostics to the market. MICS is focusing on clinical applications and clients from pharmaceuticals, diagnostics biopharma, biotech, contract research organisations (CROs), biobanks, and other players. We have been providing bespoke services to our clients and their patients for over 20 years, making strategic use of Medicover assets, including laboratories with state-of-the-art diagnostic equipment, medical clinics and hospitals, as well as the vast expertise and enthusiasm of a workforce that has grown to more than 28,500 professionals.

 

MICS’ services include and are organised along discrete lines of activity, including: Central Lab Services, Biospecimen Management, Patient Recruitment, Management and Data, and Precision Medicine. Tightly integrated in all Medicover geographies and beyond, MICS employs a dedicated team of highly specialized experts including clinical and diagnostics experts, contract research professionals, account managers, project managers, logistics, regulatory and commercial experts.

The major markets are Germany, Ukraine, Romania and Poland.

 

Due to fast growth of Medicover Integrated Clinical Services (MICS) we are looking for new Analytical Project Manager. The opportunity to become a member of a team with many years of experience in managing clinical trials.

We are located in one of the newest offices close to the heart of Gdańsk.

Jakie wyzwania czekają na tym stanowisku?
  • To provide technical support for planning, conducting and documenting all project – related activities within office and/or laboratory parts of the department;
  • Archiving all project-related documents;
  • Responsible for working in accordance to actual regulatory guidelines and internal SOPs.
  • Training of new CRC and/or CRA employee;
  • Assigning tasks to CRC or CRA;
  • Supervising CRC activities;
  • Documenting his/her activities using MICS QMS forms;
  • Preparing the study specific documentation (laboratory manual, project specific instructions, reference values lists, etc.);
  • Conducting CTLMS-LIS project specific validation;
  • Documenting sample and data discrepancies;
  • Collection of source data from testing labs;
  • Performs sample quality assessment;
  • Reports delivery to clients/sites;
  • Completion of the internal trackers;
  • Formal checking of analytical results;
  • Documenting sample errors (DCFs, NTFs, Rejection Notes, Phone call notes) and all actions during the study and adding appropriate documents into the study files;
  • Documenting all changes to client in a timely manner (ex. NTFs for legal holidays, changes which occur during the study, etc.);
  • Preparing archiving documents;
  • To provide support for the APM functions if needs;  
  • To approve the laboratory results report (formal and essential approval);
  • To contact with investigator;
  • Formal checking of project reference values list;
  • Participation to SIVs if asked;
  • Data cleaning;
  • To assist the APM in the coordination of supplies for each clinical study;
  • To coordinate all logical aspects of the project;
  • Shipment/packages quality assessment;
  • Tracking of kits expiration at study sites;
  • Performing kits quality control;
  • Coordination of study samples partially tested to other labs (affiliate, subcontracted, etc);
  • Perform materials/shipment packages quality assessment;
  • Completion of all MICS forms related to logistic issues;
  • Sampling kit design;
  • Planning, conducting and documenting all study related logistics;
  • To coordinate all laboratory activities regarding the project;
  • To supervise preparation and assembly of lab shipments;  
  • Registration the samples into LIS/CTLMS;             
  • Maintaining and developing study related relationships with subcontracted labs and vendors;
  • Ensure that all laboratory results will be sent of properly.

 

Do oczekiwań wobec Kandydatów należą...

Education:

  • Masters degree, preferable – Medical or Biological; at least 2 years experiences as a Clinical Research Assistant related experience preferred or similar role;
  • Must possess excellent organizational an interpersonal skills.
Language Ability:
  • English – communicative, other languages preferable;
  • Ability to read and interpret documents, write routine reports and Correspondence.
Math Ability:
  • Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, circumference, and volume;
  • Ability to apply concepts of basic algebra and geometry.
Reasoning Ability:
  • Ability to apply common sense understanding to carry out instruction furnished in written, oral, or diagram form;
  • Ability to deal with problems involving several concrete variables in standardized situations.     
Computer skills:
  • To perform this job successfully, an individual should have a ‘better than’ working knowledge of Microsoft Office applications including MS Word, Excel, and PowerPoint.
Co oferujemy osobom, które dołączą do naszego zespołu?
  • Full-time job;
  • Hybrid-work;
  • Contract of employment;
  • Work flexible hours;
  • Medical Care;
  • Multisport Card;
  • Private insurance.

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