The Lead Monitor is responsible for assisting the Clinical Project Manager with orchestrating clinical operational activities as well executing high quality, integrated cross-functional plans for the projects while adhering to appropriate standards and processes to ensure completion of project team goals in compliance with regulatory requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Review monitoring reports prepared by study monitors.
Identify and escalate monitoring report issues/CAPAs to Clinical Project Manager
Prepare and conduct co-monitoring visits with monitors from the study Clinical Research Organization at clinical investigative sites to ensure quality and consistency across study monitors, involving travel across the United States and Europe.
Interact with clinical study sites to resolve data queries, errors and omissions, and obtain additional information
Participate in the planning of quality assurance activities and coordinate resolution of audit findings
Field phone calls and e-mails from sites and address issues in a timely manner
Assist in improving and maintaining department SOPs.
Interact with Clinical Operations group to ensure all site and personnel training is properly documented
Prepare, oversee, and review documents that are related to assigned clinical studies
Assist with maintenance of the electronic Trial Master File
Support device accountability management
Support site regulatory inspection preparation and management
Fully involved in resolving issues; take part in procedure improvement initiatives
Required Knowledge, Skills and Abilities:
Must possess excellent communication skills so as to be able to effectively convey messages across to both study team members and other external persons like vendors and external consultants
Good problem-solving, organizational, and leadership skills are highly required
Ability to pay keen attention to detail at all times
Must be able to work within stipulated timeframes or deadlines even in the face of multiple responsibilities or projects
Must be able to work as part of a team
Must have a ‘one of a kind’ work ethic, and must exhibit a great level of self-discipline
Ability to organize and motivate other members of the study team.
EDUCATION, EXPERIENCE, and TRAINING:
B.A. / B.S. in life sciences or RN degree plus 5 + years experience in clinical trial monitoring. Knowledge of medical devices with ophthalmology experience strongly preferred.
Experience as both a field monitor and in-house CRA
Demonstrated proficiency in GCPs and knowledge of other pertinent regulatory requirements
Candidate must be willing to work in Aliso Viejo office
Well-organized and accustomed to maintaining excellent records
Able to manage multiple projects simultaneously
Must be detail oriented with well-developed organizational and analytical skills.
Must enjoy working in a fast-paced startup environment with proven ability to be flexible and adaptable within a changing dynamic environment.
Must have the interpersonal skills needed to communicate successfully with the Principle Investigators, Study Coordinators, and CRO.
CERTIFICATES, LICENSES, REGISTRATIONS:
ACRP or equivalent certification preferred
Proficient user of basic computer applications for the execution of daily project operations
Experience in writing clinical study procedures and other clinical documents is a plus
About RxSight, Inc.
RxSight™ is the global leader in adjustable intraocular lens technology. The company’s revolutionary intraocular lens (IOL) is the first and only FDA approved IOL that can be adjusted after cataract surgery to improve uncorrected visual acuity and reduce astigmatism. Using a proprietary light treatment that produces precise modifications in lens curvature, RxSight’s Light Adjustable Lens (RxLAL™) enables doctors and patients to predictably optimize vision after cataract surgery through an office based IOL enhancement.