Senior Clinical Research Associate
An exciting Clinical Research Organsation (CRO) is looking for a Senior Clinical Research Associate to join their team in Russia, St Petersburg. This is an amazing opportunity to bring your experience and knowledge to a company that effectively contributes to medicine.
- Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
- Develops strong site relationships and ensures continuity of site relationships through all
phases of the trial.
- Performs clinical study site management/monitoring activities in compliance with ICH, GCP,
- Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated
- Gains an in depth understanding of the study protocol and related procedures.
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve
- Participates & provides inputs on site selection and validation activities.
- Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
- Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.
- Performs co-monitoring visits where appropriate
Skills and Requirements
- Min. 2 years of direct site monitoring experience in a bio/pharma./CRO.
- Ability to travel domestically and internationally per country regulations approximately
- Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
- Good understanding and working knowledge of clinical research, phases of clinical trials,
current GCP/ICH & country clinical research law & guidelines.
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to
work within these guidelines.
- Demonstrated high level of monitoring skill with independent professional judgement
- Demonstrates and projects professional demeanor and communication consistent with
organizational policies and practices.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Reem Iskandarani on 02038542629 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.