Unblinded Clinical Research Associate

As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.

Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

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

• 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.

Did you know?

In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023.

We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development. www.fortrea.com

Labcorp is proud to be an Equal Opportunity Employer:

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