Our client, a mid-sized biotechnology company that specialises in inflammatory and auto-immune diseases, is seeking a CRA to join the team at their US office.
- The Clinical Research Associate (CRA) is responsible for carrying out the duties related to monitoring in compliance with applicable SOPs, international regulations and directions from management.
- The CRA must manage, with minimal supervision, sites participating in complex clinical studies and/or sites requiring more than minimal oversight of operational issues.
- Overseeing the overall activities of site personnel, over whom there is no direct authority, and be responsible to motivate/influence them to meet study objectives; additional is proactive in managing the site and ensures action plans are put in place as needed to ensure compliance.
- Conducting all clinical site monitoring activities according to the monitoring plan and in accordance with the study timelines and company objectives. While on site, the Monitor is responsible to review the ongoing efforts and activities of clinical sites, to ensure compliance with the protocol, applicable regulations and ICH Guidelines.
- Ensure accurate and adequate reporting of all issues related to safety and protection of study subjects; and ensures, through compliance with the study monitoring plan, SOPs, ICH Guidelines, and applicable regulations.
- Ongoing training of study site personnel on the protocol and applicable regulatory requirements, in collaboration with pertinent project team members.
- Reporting and escalating serious or outstanding issues, as defined in the study monitoring plan.
- Ensure the regulatory inspection readiness at assigned clinical sites.
- The timely, concise, objective, accurate and professional reporting of monitoring activities, as described and required in the Monitoring Plan.
- Ongoing review of data entered into the eCRF system, serving as a support for the site staff
- Maintains knowledge and expertise and an ongoing awareness and trends of industry practices.
Education, Skills and Experience:
- Minimum of 10 years of clinical related experience, of which at least 3 years must be as a Clinical Research Monitor
- Previous experience of working in Clinical Research, in either the pharmaceutical or CRO industries desirable
- University degree or equivalent in health sciences, nursing or pharmacy or related field desirable
- Knowledge of the Industry/Clinical trial process and drug development desirable
- Knowledge of ICH GCP desirable
- Excellent command of written and verbal English language
- Work in a team and independently
- Excellent communication skills
- IT literacy, particularly in Word, Excel, PowerPoint and Access
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 Christopher Frank on +1 267 405 6996 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.