Note: The job is a remote job and is open to candidates in USA. Precision Medicine Group is a unique CRO focused on cultivating a supportive culture and high retention rates among Clinical Research Associates. The Senior Clinical Research Associate will monitor and manage clinical studies, ensuring compliance with protocols and regulations, while also providing training and mentorship to junior staff members.

Responsibilities

• 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

Skills

• 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
• 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
• 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

Company Overview

Company H1B Sponsorship