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(K) Regional CRA (1288)
Ref No.: 18-27726
Location: Santa Ana, California
Position Description
Regional CRA Job Description
Primary Job Function
Develops, plans, guides and reports on the conduct of human clinical research studies required to enter new products into the marketplace or to expand product claims, in compliance with state and federal regulations, industry standards and corporate policies. Effectively manages multiple clinical sites (up to 12) to assure accurate and timely initiation, enrollment, conduct and completion for assigned clinical trials.
Core Job Responsibilities
Compliance with applicable Corporate and Divisional policies and procedures, guidelines, standards and regulations.
As assigned CRA for investigative site(s) on a clinical trial, responsibilities include:
Serving as primary contact for investigative site communication for each assigned site.
Collaborating with investigative sites to ensure completion and appropriate submission of all required clinical trial documents prior to site initiation.
Coordinating Institutional Review Board/ Ethics Committee (IRB/EC) approvals, as appropriate.
Training 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.
Evaluating actual enrollment against assigned targets and working with assigned sites to meet, and whenever feasible, exceed enrollment targets.
Assessing case report forms (CRFs) for trends in safety, effectiveness, and adherence to protocol.
Performing 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.
Preparing, submitting and filing of high quality monitoring visit reports and associated follow-up letters in a timely manner.
Providing regular updates to the Investigator of assigned investigative sites, Study Manager and/or Lead CRA with respect to study conduct and compliance
Monitoring overall progress of clinical trials by regularly attending project and/or clinical trial team meetings, reviewing team communications and sharing pertinent information with assigned investigative sites and clinical trial team members.
Maintaining audit/inspection readiness at assigned sites throughout the conduct and upon closure of clinical trials at assigned investigative sites.
Supporting study payment activities or accruals, as assigned.
Ensuring all equipment/supplies provided to investigative sites is appropriately reported to Study Manager and/or Lead CRA.
Position Accountability / Scope
Interacts with internal and external personnel involved in clinical research, including investigators and investigative site personnel.
Contributes 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.
Works 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.
Minimum Education
BA/BS required.
Minimum Experience/Training Required
5+ years of independent field monitoring experience for clinical trials.
Ophthalmic medical device industry experience required (e.g. intraocular lens/cataract surgery studies).
Strong knowledge and understanding of application of GCP, specifically as it applies to investigative site conduct of clinical trials.
Ability to successfully manage multiple competing priorities and adapt quickly to changing priorities.
Ability to problem-solve.
Effective communication via written, verbal and listening skills, with ability to effectively deliver training or informational presentations at internal or external meetings desired.
Proficiency with MS Word, Excel and Powerpoint required.
Proficiency with electronic data capture and electronic Trial Master File preferred.
Proven ability to operate in a home office environment with flexibility to travel and report to corporate offices, as appropriate.
Travel: 50-60% travel average