Clinical Research Associate (CRA)

Активни огласи од Талискер Проект Менаџмент ДООЕЛ:

Project Assistant

Talisker Project Management Ltd is a provider of outsourced drug and medical device development services to pharmaceutical, nutraceutical, biotechnology and health organizations in Republic of North Macedonia. Due to our successful development, we are looking for highly motivated and responsible candidates for the position of:
Clinical Research Associate (CRA)
The Responsibilites:

  • Site selection and qualification;
  • Set-up of a study with regard to submission and approval process and preparation of the documentation as per all applicable local requirements;
  • Coordinates, assists (if needed) and participates in any trainings and meetings (incl. Investigator Meetings) related to the specific study;
  • Provides monitoring and quality control of the work of investigational sites; plans and performs monitoring visits in accordance with GCP and the study protocol;
  • Reviews and reports all protocol deviations/violations, all AE/ SAEs to sponsor and takes the responsibility for accurate performing of SDV process, ensures proper transferring of CRF data to DM;
  • Reports trial progress to the client by writing reports and collecting trial specific data, keeping correspondence, participating in project meetings and teleconferences;
  • Ensures the study is conducted in accordance with international and national regulatory requirements: prepare and follow up EC and regulatory submission; keep EC and Regulatory authorities informed about any protocol and ICF changes, report SAEs, submit study progress report at least once per year;
  • Provides any requested internal progress reports and completion of the relevant files;
  • Ensures proper termination and performs any activities related to close out of all study sites and proper finalization of contracted tasks;

The Person:

  • Graduate or postgraduate degree in the filed Medicine or Pharmacy;
  • Good analytical and problem-solving skills;
  • Strong communication skills and ability to work in a team;
  • Proficiency in English;
  • Computer literacy (Word, Excel, and Power Point);
  • A valid driving license and readiness to travel within the country and abroad;

The Company Offer:

  • Job-specific training;
  •  Work for successful company, excellent career development opportunity in a perspective professional field;
  • Very competitive remuneration package;
  • Additional benefits related to work performance.