Careers at SMS-oncology
Senior Clinical Research Associate (Senior CRA)
As a Senior CRA at SMS-oncology you are responsible for ensuring that investigational sites perform our clinical studies according to the study protocol and in compliance with SOP's, applicable regulations and the principles of Good Clinical Practice. You will act as the main line of communication between the sponsor and the investigator and will perform regular monitoring visits. Moreover, you will assist in identifying, selecting and initiating investigational sites.Role and Responsibilities
- Identifying and recruiting investigational sites
- Performance of selection and initiation visits
- Assisting in the preparation of regulatory submission packages and obtaining approval from investigational sites
- Provide input on study related documents
- Performing monitoring visits to verify that source data/documents and other trial records are accurate, complete, and maintained
- Verifying patient eligibility and communicate document protocol violations and non-compliance
- Verifying whether Serious Adverse Events are reported according to safety regulations
- Checking drug accountability at the investigational sites
- Acting as the main line of communication between the sponsor and the investigator
- Preparation and maintenance of all necessary study files and documentation
- Ensuring that investigators achieve their patient recruitment targets
- Liaising with the project manager to ensure he/she is kept informed
- Preparation of monitoring visit reports
- Ensuring a timely and accurate resolution of data management queries
- Assisting in the performance of feasibility studies for new proposals
- Supporting site staff in preparation for trial site audits and inspections
- Participation in the training of new Clinical Research staff
- Maintaining a good level of scientific knowledge within the therapeutic areas
Qualifications and Characteristics of the Ideal Candidate
- Degree in medicine, health care, life sciences or related fields
- At least 2 years of monitoring/CRA experience
- Experience with coordinating other CRAs or leading a team
- Great interest in oncology
- Ability to review and evaluate clinical data
- In-depth knowledge of Good Clinical Practice (GCP) and local regulations and processes
- Experience in clinical research preferred
- Good communication skills
- Representative and outgoing
- Administrative excellent
- Self motivated and proactive
- Willingness to travel at least 25% of the time (international and domestic: fly and drive)
- Understanding of the Dutch language
- Fluency in written and spoken English
- Foreign language skills preferred
- In possession of driving license
Contact
For more information please us at Recruitment@SMS-oncology.com