ProClinical are partnering with a leading CRO to advertise a vacancy for a CRA position. This company, which specialises in bioanalytical services for pre-clinical and clinical developments, is seeking for the incumbent to the position to join their team in Beijing. This is an exciting opportunity to work with a company that seeks to overcome challenges in bioanalysis with expertise, rapid turn-around-time and high-quality services.
- Functioning as country monitoring lead for complex BE/Phase I studies and small patient PK/clinical endpoint studies, as well as later phase studies as required.
- Serving as liaison between the company project team and clinical investigators regarding study site activities.
- Managing assigned studies to include site management and monitoring functions to include co-monitoring as needed.
- Assisting in the preparation project plans and providing project reports to management as needed.
- Ensuring the project is compliant with assigned study protocols, overall clinical objectives, GCP, SOPs, and applicable local, state, and federal requirements.
- Maintaining all required regulatory study documents, monitoring records, and correspondence confidentially and in accordance with company document control procedures for assigned studies.
- Reviewing clinical and drug product documents for accuracy, completeness, and timeliness internally and at the research sites.
- Reviewing Regulatory Documents, Drug Release/Accountability paperwork, Source Document templates, Case Report Form (CRF) templates, Informed Consent Forms, Adverse Events, Dosing Logs, Protocol Deviations, completing source documents, completed CRFs, and Clinical Reports.
- Conducting clinical monitoring of studies, both remotely and on-site, according to SOPs and Clinical Monitoring Plan (CMP). This include visit preparation, monitoring process, completing monitoring reports, visiting follow-up activities, and travelling to and from the clinical locations.
- Interviewing clinical site research personnel in follow-up of monitoring visits and data issues, communicating any substantial findings to their supervisor and clinical investigator during immediately following a monitoring visit.
- Monitoring and/or following-up on the implementation of corrective action plans following clinical site inspections or audits, as required.
- Developing and reviewing SOPs where required.
- Identifying improved operational methods for functional area.
- Overseeing and assisting in training of new Clinical Research Associates.
- Performing other duties as assigned.
Skills and Requirements:
- A degree in a relevant field.
- Demonstrable CRA experience.
- Demonstrable expertise in Clinical Trial design.
- A thorough understanding of clinical pharmacology.
- Working knowledge of biostatistics, data management, and clinical operations' procedures.
- Proficiency in the drug development process.
- Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solve problems.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, persuasion, influence, and leadership.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Richard Hao on +6531591467 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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