Address
Form of workJob Summary:
The Clinical Research Associate (CRA) will have a keen attention to detail and has the ability to both prioritize and handle multiple tasks effectively in a rapidly growing company environment. The CRA will support development programs.
The CRA will be expected to participate in the processing and performance of quality assurance checks of clinical trial data to ensure data integrity and consistency across clinical programs and in accordance with standard operating procedures and Good Clinical Practices (GCP).
Essential Responsibilities:
The Clinical Research Associate (CRA) will have a keen attention to detail and has the ability to both prioritize and handle multiple tasks effectively in a rapidly growing company environment. The CRA will support development programs.
The CRA will be expected to participate in the processing and performance of quality assurance checks of clinical trial data to ensure data integrity and consistency across clinical programs and in accordance with standard operating procedures and Good Clinical Practices (GCP).
Essential Responsibilities:
- Consistently performs duties within established Standard Operating Procedures, and in accordance with Good Clinical Practices.
- Performs verification and quality control of essential regulatory documents and is well versed in the organization of a trial master file.
- Conducts sponsor oversight visits to the study sites as required.
- Conducts regular data reviews from clinical database.
- Maintains study specific tracking tools and project files.
- Assists in managing investigational product supplies at the country (where applicable) and trial site level, keeping sites informed of drug lots/batches and expiration dates. Ability to review and perform drug accountability if required.
- Assists in the preparation of site and in-house Sponsor inspections.
- Maintains/develops a good level of scientific knowledge within the Project's therapeutic area.
- Reviews, comments and tracks monitoring reports and follow-up letters.
- Supports Data Management with start-up and maintenance of the clinical databases (UAT).
- Prepares and participates in Investigator site safety meetings.
- Communicates with sites, study coordinators, and site pharmacists as needed
- Knowledgeable about IWRS systems.
- 2-3 years of Clinical Research monitoring experience through a Clinical Research organization (CRO) or pharmaceutical company.
- Requires a BS degree or equivalent in a health science field preferred.
- Oncology experience required.
- Excellent computer skills (Microsoft Office Word, Excel, Outlook) required.
- Sound working knowledge of knowledge of the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines and other applicable regulatory guidelines required.
- Global trial experience a plus.
- Up to 20% travel required.
