Clinical Research Associate

21 hours ago


Fatih, Istanbul, Turkey Ascot Science Full time

Are you looking for a company that cares about people's lives and health, including yours?

Ascot Science is a fast-growing company seeking to bring the best talent in the industry to our lineup of amazing staff members. As a CRO, Ascot is committed to excellence in clinical trial and pharmaceutical innovation by delivering in-depth expertise - through interdisciplinary experience. Our clients include pharmaceutical companies, medical departments, clinical trials departments, regulatory affairs departments, regulatory authorities, and patient advocacy groups in Turkey and worldwide.

Now we are looking for another member to join our family

Job Overview

As a clinical research associate (CRA), you'll run clinical trials to test drugs for their effectiveness, risks, and benefits to ensure they are safe for the intended use. You'll work on new and existing drugs and will typically be involved in all stages of the clinical trial, including identifying an investigational site and setting up, initiating, monitoring, and closing down the trial.

Clinical trials may be carried out at various stages or phases and include trials on healthy humans, trials on patients with a disease, and studies conducted after the launch of a new drug to monitor safety and side effects.

To verify that the conduct of the study is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s), and report any deviation as per the study procedure.

Job Responsibilities
  1. Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
  2. Communicate with the medical site staff including coordinators, clinical research physicians, and their site staff;
  3. Support preparation of regulatory and/or EC submission when requested;
  4. Investigational product/drug accountability and inventory;
  5. Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
  6. Assess the clinical research site's patient recruitment and retention success and offer suggestions for improvement;
  7. Complete monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance and archive study documentation and correspondence.
Job RequirementsEducation
  • A bachelor's degree in health sciences, medical science, or a scientific field is required.
Experience
  • Four (4) + years of experience in Clinical Trials, at least 2 years in monitoring;
  • Ability to communicate in English (both verbal and written);
  • Ability and willingness to travel;
  • Proficiency in the use of project management tools and techniques (e.g., MS Project, MS Excel, MS PowerPoint).
Skills
  • The ability to build effective relationships with trial center staff and colleagues;
  • The ability to motivate others;
  • An excellent grasp of numeracy and a keen eye for detail;
  • The ability to multitask and think on your feet;
  • A flexible and adaptable approach to work;
  • Organizational, IT, and administrative skills - the job involves a lot of documenting and recording information through computerized processes, such as clinical trial management systems and electronic data capture;
  • An understanding of the importance of good clinical practice (GCP), a legal requirement for all CRAs.
Employment Type

Full-time

Seniority level

Mid-Senior level

Job function

Research, Analyst, and Information Technology

Industries

Pharmaceutical Manufacturing

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