Senior Clinical Research Associate- Oncology

2 weeks ago


Manchester, United Kingdom OrciTrials Full time

**Senior Clinical Research Associate
- Oncology**

OrciTrials is looking for an experienced Clinical Research Associate for its client in UK.

The CRA must have past experience with oncology and will be responsible for monitoring clinical trials and ensuring investigators are conducting research within the requirements of the clinical protocol and ICH-GCP.

**Position Accountabilities/Responsibilities**:

- Work with the study start up group to coordinate activities with the site in preparation for the initiation of studies
- Set up trial sites, ensuring that each center has the necessary trial materials
- Work with the study start up group and site staff to obtain regulatory (IRB/IEC) approval of study specific documents
- Ensure study documentation is maintained in the Investigator Study File and where necessary ensure relevant documents are transferred or copied to the (electronic) Trial Master File
- Monitor trials throughout their duration, conducting periodic site file audits to ensure compliance with GCP and the company’s standard operating procedures
- Ensure adherence to Good Clinical Practice, investigator integrity and compliance with all study procedures through on site monitoring visits
- Work with sites to resolve any data queries as required
- Assist with and attend investigator meetings for assigned studies
- Developing and reviewing protocols, eCRFs, study manuals and other related documents as requested by the Clinical Trial Lead
- Act as the primary contact between the client and the investigator, coordinating all correspondence and ensuring timely transmission of clinical data with the study site and technical reporting as necessary
- Assist with final data review and query resolution through to database lock
- Perform study close out visits and archive study documentation and correspondence
- Act as a mentor for new clinical research associates

**Qualifications and Requirements**:

- Degree or equivalent qualification in life sciences or relevant field with proven experience in the field of monitoring ideally early phase Oncology
- At least 2+ years of monitoring experience with strong focus on oncology
- Sound knowledge of clinical research process and medical terminology
- Good understanding of electronic data capture, including basic data processing functions
- Good understanding of current ICH-GCP (R2) guidelines applicable to the conduct of clinical research
- Willingness and ability to travel domestically (and occasionally internationally) as required
- Excellent verbal and written communication and interpersonal, negotiation and conflict resolution skills



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