Horsham, West Sussex RH12 4QP GB
The CRA / Sr. CRA is responsible for site management and monitoring activities associated with clinical studies. This position may be assigned to monitor a specific study or studies, co-monitor with other CRAs, assist in the assessment of Cmed or contract CRAs, or provide other support to Clinical Operations which is appropriate for their level of expertise.
- Perform site qualification, site initiation, interim monitoring, close-out visits for Phase I - IV studies onsite or remotely in accordance with current ICH GCP guidelines, local regulatory requirements and appropriate SOPs.
- Confirm investigator adherence to ICH GCP, local regulatory requirements and to the protocol procedures.
- Adhere to the project plans, as applicable, for assigned studies.
- Complete and submit timely site visit reports per the monitoring plan/SOPs.
- Verify investigator maintenance of study documentation throughout the life of the study including essential documents, Investigator Site File, source documentation, drug accountability, and safety reporting.
- Serve as primary point of contact for assigned sites establishing and maintaining a good working relationship with site staff.
- Discuss, review, and document patient recruitment strategies with assigned sites.
- Work with Project Leader (PL), and/or Clinical Team Lead (CTL)/Clinical Trial Manager (CTM) to ensure that clinical monitoring activities are conducted on time, in accordance with the monitoring plan.
- Support assigned sites with vendor issues (e.g., Central Laboratory, IXRS, imaging, etc.) as they arise.
- Provide any additional training as identified throughout the study (e.g., protocol amendment, query trends) to site staff as needed.
- Work with site staff on timely data entry and query resolution
- Assist in the development of study related trackers and monitoring tools as requested.
- Review, in conjunction with Clinical and/or Data Managers, the quality and integrity of the clinical data through source data review, source data verification, and inhouse review of electronic CRF data.
- Liaise with Data Management during all stages of a study to assist with query resolution as required.
- Assist the PL, and/or CTM/CTL with updating study metrics and compiling status reports.
- Assist with training of CRAs.
- Participate in study team meetings as required.
- May lead CRA meetings, if required.
Other Clinical Operations Activities
- Co-monitor as needed.
- Perform onsite or remote visits to assess CRA performance.
- Provide additional support to Clinical Operations staff as needed.
- Participate in department initiatives to enhance Clinical Operations
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