ProClinical is now recruiting for an opening as a Clinical Study Assistant, operating on a permanent basis in Santa Ana, CA. The role includes providing administrative and organizational support for assigned clinical trials and sites in accordance with Good Clinical Practice (GCP), guidelines, standards, federal regulations and SOPs, as well as close collaboration with other members within Clinical R&D.
- Comply with applicable corporate and divisional policies and procedures, guidelines, standards and regulations.
- Serve as internal support for all members of assigned teams.
- Support investigative sites toward completion and appropriate submission of all required clinical trial documents prior to site initiation.
- Support establishment and maintenance of Trial Master Files for assigned clinical trials.
- Coordinate Institutional Review Board/ Ethics Committee (IRB/EC) approvals as appropriate.
- Support overall progress of clinical trials by regularly attending clinical trial team meetings, reviewing team communications and sharing pertinent information with clinical trial team members and investigative sites as requested.
- Assist assigned clinical trial teams to ensure that each clinical trial maintains audit/inspection readiness at each site and internally throughout the duration of assigned clinical trials.
- Ensure all equipment/supplies provided to investigative sites is appropriately tracked and reported to Study Manager and/or Lead CRA.
- Interact with internal and external personnel involved in clinical research, including investigative site personnel, as appropriate.
- Support the successful execution of assigned studies within budget and in conformance with global regulations and internal policies and procedures.
- Work with significant supervision.
Skills And Requirements
- BA/BS degree.
- 1-2 years clinical research experience preferred.
- Ability to problem-solve, multi-task and prioritize across tasks.
- Fluent in English (written and verbal).
- Strong communication skills (written and verbal).
- Proficiency in Microsoft Office.
- Ability to report to corporate offices for routine, daily work.
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 Eleni Farrell at (+1) 267 405 6996 or upload your resume 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.