Senior Clinical Research Associate

About you:

• You are calm, thoughtful, and responsive when things don’t go as planned.
• You are well-prepared, whether it be for an investigator meeting, site visit or project team update, always staying two steps ahead of the game.
• You find quick and creative ways of overcoming difficulties.
• You have an impeccable eye for detail.
• You identify potential study risks and propose solutions on how to mitigate them.
• You take responsibility in the quality and outcomes of your work.
• You are adept at handling conflict by using tried and true resolution strategies.

How we will keep you busy and support your growth:

You will monitor and own the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards. You will coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).

Senior CRAs handle appropriately sized clinical trials, and support Project Managers with trials that are larger in scope. You will also have the opportunity to train and mentor junior staff members. You will interact directly with clients, initiate payments, and participate in proposal activities, including development and client presentations.

Qualifications:

• Minimum Required:
  • University degree life science/pharmacy/other health related discipline or equivalent experience in a scientific or healthcare discipline or be a licensed health care professional.
  • 3.5 years or more as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. Significant site management experience or equivalent experience in clinical research
  • Oncology monitoring experience
• Other Required:
  • Excellent communication and organizational skills are essential. A team player
  • Evidence of a client focused approach
  • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
  • Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed
  • Fluency in English and Turkish
• Preferred:
  • Graduate, postgraduate degree
  • Experience monitoring in rare and complex therapeutic areas
  • Experience monitoring EDC trials and HER records
  • Experience in bioharma or relevant therapeutic area
  • Start up experience