Proclinical is currently recruiting for a Senior CRA II with a CRO located in Pasadena, CA and Frisco, TX. Successful candidate will perform assigned tasks within clinical research studies and projects as defined by the Project Lead in accordance with company procedures, the protocol and other study plans as applicable, global, local and specific regulations.
- Prepare project-specific support materials and templates in accordance with protocol and other specifications.
- Assist in the preparation of project and monitoring plans; implement activities as described to required quality standards, timelines and any other specifications.
- Perform site identification, site feasibility and site selection as required.
- Manage assigned investigational sites from pre-study to close-out and archiving, including remote or centralized monitoring activities as required.
- Perform on-site monitoring visits from pre-study to close-out.
- Conduct technical and protocol training of investigational site personnel, as required.
- Manage the content of project site-level Trial Master Files and ensure accuracy and completeness.
- Ensure timely, effective communication with investigational sites, within project teams, with the company and as appropriate, with Client.
- Assist in the preparation and management of regulatory and ethics applications for clinical research studies as required.
- Provide regular progress updates to the Project Lead.
- Any other reasonable task as approved by your Line Manager.
Skills and Requirements:
- Science Graduate, or appropriate level of experience as a health care professional.
- A higher degree is desirable but not essential.
- At least 2 years of monitoring experience within the pharmaceutical industry.
- Well-developed knowledge and understanding of the principles of Good Clinical Practice and able to demonstrate practical application.
- Good knowledge of drug development process and clinical study phases and competent level of clinical research literacy and use of terminology.
- Basic project management skills; demonstrates competence in coordinating appropriately delegated tasks to pre-defined requirements, including planning, timelines, tracking and reporting.
- Accomplished user of Microsoft Office, ability to create and format documents to a good, consistent standard, efficient use of Internet.
- Strong attention to detail.
- Well-developed language skills demonstrated ability to communicate effectively in a range of electronic and face to face settings.
- Experience in clinical trial authorization approval process in local region.
- Highly motivated, pro-active approach to tasks; able to work effectively within a team or independently.
- Well-developed organizational and time management skills; able to prioritize tasks and work to timelines.
- Competent and confident to work efficiently across company departments and with a variety of external vendors, using various modes of communication (email, letter, telephone).
- Experience with software systems (EDC, CTMS, eTMF, IXRS)
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 Susan Chapman at (+1) 646-542-0158 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.
Proclinical Staffing is an equal opportunity employer.