Unblinded Clinical Research Associate

1 week ago

Melbourne, Australia Labcorp Full time

As uCRA, you typically will:

- Own all aspects of pharmaceutical site management as described in the study monitoring plans
- Ensure accurate pharmacy documentation
- Maintain investigational medicinal product (IMP) accountability
- Ensure blinded and unblinded site staff members can work in a coordinated manner without compromising the blinded monitors
- Oversee that IMP supplies are maintained in suitable storage conditions and are accurately reconstituted, dispensed, administered, returned and destroyed.
- Cooperate closely with blinded CRA site leads to ensure contracts and agreements (e.g. Site Blinding Plans) are developed and signed off per the unblinded delivery requirements.
- Review Case Report Forms (CRF), generate queries and resolve issues in accordance with established data review guidelines on Covance or client data management systems
- Write trip reports after each onsite or remote visit
- Support the sites (pharmacies) with any issue / question they have concerning the IP (investigational product)
- Conduct regular eTMF (Trial Master File) updates
- Participate in regular study team calls and internal departmental meetings
- Travel within local state and/or country (dependent on site allocation and business need), on rare occasions international travel may be required

**Experience**:

- Experience in clinical research
- Minimum 12 months previous unblinded monitoring experience
- Awareness of applicable clinical research regulatory requirements such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)
- Working knowledge of Microsoft Word, Excel and PowerPoint
- Effective time management and organizational skills and a keen attention to detail
- Ability to establish and maintain effective, trustful working relationships with internal and external stakeholders
- Business fluency in local language, both spoken and written - as well as a good command of oral and written English are a must.

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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