Our client, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, is looking for experienced CRAs / SCRAs with different therapeutic experiences to join a global success story. They are seeking a 0.8 - 1.0 FTE for Germany. This post can be home based for those with previous experience and a home office.
JOB ROLE: Working within a highly qualified team you will identify, select, initiate and close-out investigational sites for clinical studies, ensuring that applicable regulations and principles of ICH-GCP and company/client SOP''s are adhered to.
PRINCIPAL RESPONSIBILITIES include:
Recruitment of investigators
Conduct regular monitoring visits in accordance with our client''s site monitoring SOP''s
Independent and proactive coordination of all activities required to set up and monitor a study, completing study status reports and study documentation
Timely submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested
Participate in preparing and reviewing study documentation and feasibility studies
Managing sponsor generated queries efficiently and responsible for study cost effectiveness
Participate, if requested, in the preparation of and review of study documentation
Responsible for the conduct/management of any aspect(s) of a project, when requested and authorized by a Project Manager.
Act in a Lead role on a study if appropriate. .
Participate in training and mentoring new staff up to Clinical Research Associate level as appropriate.
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
Degree in science, medicine or equivalent
Previous monitoring experience of medium sized studies, including study start up and close out.
Knowledge of ICH GCP guidelines
Fluency in English and local language
PERSONAL SKILLS & ATTRIBUTES:
Excellent written and verbal communication skills
Computer literate with Microsoft Office
Ability to produce accurate work to tight deadlines within a pressurized environment
Excellent interpersonal skills will be essential to enable you to deal with any queries in a timely manner
Available to travel both internationally and domestically at least 60% of the time
Possess a valid driving license
BENEFITS OF THE ROLE: This company has an outstanding track record with a style of work that has been rated as the highest in the in the industry. They are committed to providing all the assistance and support you require to enable you to reach your goals. Salaries are competitive and they offer an excellent benefits package including financial and long service awards.
Fforde is acting as a recruitment agency/business.
KEYWORDS: CRO, Clinical, Clinical Research, Clinical Research Associate, SCRA, Senior Research Associate, Research Associate, Drug Development, Pharmaceutical, Clinical Studies, Clinical Trials, Science, ICG, GCP, ICH, Cardiology, Oncology