Clinical Research Associate

Avania is currently looking for a Clinical Research Associate, located in Australia_
- Working for Avania is working in a diverse environment; from performing studies in a pre-market phase to PMCF studies, with start-ups to multinationals. All within a broad spectrum of diverse medical devices, IVDs, biologics, and device-drug combination products, internationally with a customized approach. As a CRA you will be the lead for several studies running in parallel, in all associated clinical trial phases, from regulatory submissions to close out visits, from site management to sponsor management, all in cooperation with our medical writing department and data analytics department._
- As we believe that believe collaboration yields the best results, we value teamspirit. Several inhouse and international active team trips are organized each year in order to share knowledge, build an open communication and comradery._

**Clinical Trial Monitoring**:

- Oversee clinical trial activities at investigational sites (will require travel to investigational sites).
- Conduct and write accurate visit reports in accordance with SOPs and GCP, including pre-study, site initiation, routine monitoring, and close-out visits.
- Interact with and guide study investigators and study coordinators in conducting clinical trials in accordance with study protocols.
- Ensure data entered on the CRFs by investigational sites is performed in a timely manner and verify that data is consistent with patient clinical notes, known as source data/document verification (SDV).
- Collaborate with analytical services as appropriate, to obtain clean database, resolve queries and conduct or participate in data reviews (both internally and with sponsor), identifying and communicating trends or erroneous data.
- Monitor site’s completion of action items between visits.

**Study-Specific Documents and Files**:

- Prepare for audits and inspections.
- Participate in internal TMF reviews, as needed.
- Review and write informed consent forms.
- Review of protocols, investigator brochures on compliance with applicable regulations and CRFs in development.

**Regulatory Affairs**:

- Prepare submissions to Ethics Committees (ECs) and Competent Authorities (CAs)/Food and assist in administrative tasks for submissions.
- Prepare confidentiality agreements and complete templates of clinical trial/investigator agreements.
- Prepare annual trial progress reports for IRBs/ECs and CAs/FDA under supervision.
- (Assist in) reporting Serious Adverse Event to Sponsor, IRBs/ECs, CAs/FDA and investigators.

**Communication and Meetings**:

- Participate in project meetings and investigator meetings and write minutes.
- **Additional Responsibilities**:

- Perform submissions to Ethics Committees (ECs) and Competent Authorities (CAs) and follow up until approval is obtained.
- Prepare annual trial progress reports for IRBs/ECs and CAs/FDA.
- Report Serious Adverse Events to Sponsor, IRBs/ECs, CAs/FDA and investigators.
- Prepare clinical trial agreements and discuss/negotiate between site and Sponsor.
- B.A./B.S. or equivalent experience in a (para)medical, scientific or health related discipline or related work experience.
- Previous experience with medical device or medical technology studies strongly preferred
- Ability to understand basic and complex medical details
- GCP-ICH-E6, FDA regulations and ISO 14155, 13485 and 9001 knowledge where applicable
- Knowledge of regulatory regulations and guidelines on medical devices
- Ability to travel
- Fluent English, spoken and written

**We offer**
- Dependent on your experience, a well outlined training program will be setup to become a medical devices expert
- The possibility to be involved in and be responsible for all aspects of a medical device clinical investigation
- The opportunity to work internationally thereby enhancing your experience
- A dynamic, enthusiastic team

We look forward to receive your motivation and CV