Regional Senior CRA
ProClinical has a permanent opening for a new Regional Senior CRA, based in Santa Ana, CA. The right applicant will develop, plan, guide and report on the conduct of human clinical research studies and will be required to enter new products into the marketplace or expand product claims, in compliance with state and federal regulations, industry standards and corporate policies. Additionally, the right applicant will manage multiple clinical sites (up to 12) to assure accurate and timely initiation, enrollment, conduct and completion for assigned clinical trials.
- Comply with applicable corporate and divisional policies and procedures, guidelines, standards and regulations.
- Serve as primary contact for investigative site communication for each assigned site.
- Collaborate with investigative sites to ensure completion and appropriate submission of all required clinical trial documents prior to site initiation.
- Coordinate Institutional Review Board/ Ethics Committee (IRB/EC) approvals, as appropriate.
- Train investigative site personnel to ensure compliance with study requirements and GCP, including, but not limited to the protocol, IRB/EC instructions, industry guidelines, international standards and local and national regulations.
- Evaluate actual enrollment against assigned targets. Work with assigned sites to meet, and whenever feasible, exceed enrollment targets.
- Access case report forms (CRFs) for trends in safety, effectiveness, and adherence to protocol.
- Perform on-site monitoring activities for assigned investigative sites in compliance with the approved monitoring plan and SOPs, with specific tasks to include:
- Ensuring that final CRFs are accurate and complete by verifying against source documentation, as assigned.
- Ensuring that all clinical trial documentation is properly reviewed, approved and filed within the Trial Master File and is accessible to investigative site personnel.
- Ensuring investigational product and, as applicable clinical supplies accountability, handling and documentation are sufficient to continue, accurate, updated and appropriately delegated.
- Prepare, submit, and file high-quality monitoring visit reports and associated follow-up letters in a timely manner.
- Provide regular updates to the Investigator of assigned investigative sites, Study Manager and/or Lead CRA with respect to study conduct and compliance
- Monitor overall progress of clinical trials by regularly attending project and/or clinical trial team meetings, review team communications and share pertinent information with assigned investigative sites and clinical trial team members.
- Maintain audit/inspection readiness at assigned sites throughout the conduct and upon closure of clinical trials at assigned investigative sites.
- Support study payment activities or accruals, as assigned.
- Ensure all equipment/supplies provided to investigative sites is appropriately reported to Study Manager and/or Lead CRA.
- Interact with internal and external personnel involved in clinical research, including investigators and investigative site personnel.
- Contribute to the successful planning and execution of assigned studies within budget and in conformance with global regulations and internal policies and procedures.
- Accountable for performance and compliance of assigned investigative sites.
- Work with relative autonomy and some supervision.
- Failure to achieve results or erroneous decisions or recommendations may cause delays in project schedules and may result in the allocation of additional resources.
Skills And Requirements
- 5 years independent field monitoring experience for clinical trials.
- Ophthalmic medical device industry experience (e.g. intraocular lens/cataract surgery studies) strongly preferred.
- Strong knowledge and understanding of application of GCP, specifically as it applies to investigative site conduct of clinical trials.
- Multitasking skills.
- Problem-solving skills.
- Effective communication skills (written and verbal).
- Proficiency in Microsoft Office.
- Proficiency with electronic data capture and electronic Trial Master File preferred.
- Ability to operate in a home office environment, with flexibility to travel and report to corporate offices as appropriate.
- Ability to travel up to approximately 70%.
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 Estella Nchumuluh on (+1) 267 943 3657 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.