Senior Clinical Research Associate
Background & Qualifications
- University degree, preferably from Healthcare related areas (Pharmacy, Veterinary, Chemistry, Biology, Medical etc. Faculties),
- Good level of English,
- Minimum 3 years experiences in a CRA position
- Strong communication and negotiation skills,
- Ability to prioritize and handle multiple tasks,
- Effective planning and organizational skills with a result-oriented approach,
- Analytical thinking, critical reasoning ability,
- Good command of MS Office applications,
- No restriction to travel,
- Driving License,
- No military obligation for male candidates.
- Perform monitoring and site management activities for phase trials projects to assess the progress of clinical projects at assigned investigative/physician sites
- Ensure clinical project is conducted, recorded, and reported in accordance with the protocol, Company SOPs, ICH-GCP, and all applicable local and legal requirements.
- May assume clinical functional leadership tasks are assigned, actions as Lead CRA for project
- Train, support and advise Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
- Drive performance at the sites. Proactively identify and ensure timely resolution to study-related issues and escalate them as appropriate.
- Perform regular Site Quality Risk Assessments and adapt monitoring intensity accordingly during the study.
- Ensure data query resolution in a timely manner.
- Work with data management to ensure the robust quality of the collected study data.
- Collaborate with local MSLs as directed by LSM or line manager.