Clinical Research Associate II
2 weeks ago
As a leading global contract research organization (CRO), Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.
Key Responsibilities
The successful candidate will be responsible for all aspects of study site monitoring, including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, and liaison with vendors.
Requirements
- Responsible for all aspects of site management as prescribed in the project plans
- Ensure the study staff who will conduct the protocol have received the proper material and instructions to safety enter patients into the study
- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
- Monitor data for missing or implausible data
- Ensure the resources of the Sponsor and Labcorp Drug Development are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines
Additional Responsibilities
The successful candidate may be required to work in a client-facing environment, track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE, and independently perform CRF review; query generation and resolution against established data review guidelines on Labcorp Drug Development or client data management systems.
Fortrea is a global contract research organization with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.
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