Clinical Research Associate (CRA)

Job description

Job Description

We are looking for our team a CRA to support the goals of the Global BU by initiating, monitoring, and closing out clinical study sites following GCP and ICH guidelines as well as Novartis SOPs and ensuring that study milestones are met. Represent Novartis Oncology at investigational sites. Central point of communication between Novartis and Investigators for all Oncology clinical trial related activities

Major Activities
- Nominate new sites for clinical trials; analyze capability and make recommendation for trial inclusion.
- Ensure trials are conducted on time and budget, while fully GCP, ICH and Novartis SOP compliant.
- Facilitate preparation and collection of site level documents; resolve problems as required. Plan and execute site initiation and training. Monitor assigned study sites under supervision according to the monitoring plan including source document verification
- Take responsibility for all aspects of site management including monitoring visits, assessment of regulatory compliance, drug supply management and resolution of site problems.
- Track trial execution milestones; identify problems; resolve issues and escalate as Appropriate.
- Create and manage site initiation and patient recruitment plans.
- Develop and execute contingency plans, as needed. Ensure that study milestones are met as planned Prepare study monitoring reports. Manage data collection and clean-up at study sites; resolve technical and content issues as needed to achieve database lock targets.
- Update electronic systems (e.g.ClinAdmin, EDC) as required
- Assist in data query resolution process
- Perform Site Closeout activities under supervision
- Attend Oncology and project specific training as well as general CRA training as required

Desired profile

Minimum requirements

- A degree in a scientific or health care discipline preferred.
- Fluent French and English (oral and written).

1. Demonstrated ability to coordinate, organize and communicate
2. Solid understanding of clinical development process including GCP and ICH guidelines.
3. Proven ability to work on teams and deliver on commitments.
4. Knowledge and experience in international (FDA, EMEA) and local regulations as well as Novartis stand-ards.
5. At least 2 years experience as CRA
6. Good communication skills
7. Ability to manage multiple priorities