OVERVIEW: The Senior CRA is responsible for creation and maintenance of the electronic Trial Master File, monitoring and site management of up to three clinical sites, and other clinical study administrative tasks of similar complexity.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Prepare and conduct study initiation, monitoring and closeout visits at clinical investigative sites to ensure adherence to procedures, protocols and project plan in accordance with FDA /ICH (E6) regulations and guidance
Assures that research site personnel are conducting the study according to the protocol and that sites are in compliance with all applicable regulatory requirements and GCP guidelines
Interacts with the clinical study sites to resolve data queries, errors and omissions, and obtain additional information on potential serious adverse events
Monitor clinical studies to ensure the quality, integrity and completeness of data verified against source documentation both on site and remotely
Verifies the accuracy and completeness of CRF data against source documents; assures timely and complete data entry into
Serves as the primary liaison with research sites; monitors the day-to-day conduct of the study and resolves problems associated with the study; provides administrative and logistical support as
Prepares and submits accurate and timely monitoring reports.
Review, track and manage study documents for completeness and accuracy (clinical reports, Serious Adverse Events, review case report forms for accuracy and completeness as well as query resolution, study supplies, study device shipments, and enrollment logs)
Assume responsibility for multiple sites to ensure compliance with Good Clinical Practices (GCPs) and study procedures, including reviewing regulatory documents and preparing reports while meeting timelines/milestones
Responsible for monitoring studies against defined milestones and timelines to assure that all deliverables are met as described in the Monitoring
Must be willing to assume monitoring and co-monitoring responsibilities as needed, involving travel across the United
Interact with sites to discuss study specifics including future new studies, assist with protocol review and finalization, IRB submissions, oversee study start-up activities, conduct training sessions for new site study staff,
Field phone calls and e-mails from sites and address issues in a timely manner
Assist the Contract Research Organization as needed to resolve queries, etc.
Develop collaborative relationships with investigative sites and with the Calhoun Vision clinical operations team
Prime responsibility for maintenance of clinical trial master file (CTMF) using electronic CTMF program for all clinical sites
Perform CTMF reconciliation for all sites to determine status of CTMF documents and address missing items·
Perform ongoing CTMF reconciliation on a quarterly basis
Work with CTMF vendor to validate CTMF software
Maintain and update all trial spreadsheets
Assists in improving and maintaining department SOPs.
Oversight for all study close-out activities and transfer of Clinical Trial Master Files into archives.
EDUCATION, EXPERIENCE, and TRAINING:
B.A./B.S. in life sciences or RN degree plus 5 years' experience m clinical trial monitoring. Knowledge of medical devices preferred.
Experience as both a field monitor and in-house CRA
Experience with maintenance of clinical trial master file
Demonstrated proficiency in GCPs and knowledge of other pertinent regulatory requirements
Basic knowledge of medical terminology including ophthalmic terminology
Ability to effectively work independently
Excellent verbal and written communication skills and computer proficiency (Word, Excel, Outlook).
Candidate must reside in or be willing to locate to the greater Los Angeles area
Well-organized and accustomed to maintaining excellent records
Evidence of applied knowledge of applicable FDA regulations, guidance’s and consensus standards
Able to manage multiple projects simultaneously
Must have a self-driven ability to investigate and understand
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
Must have the interpersonal skills needed to communicate successfully with the Principle Investigators, Study Coordinators, and
Experience with eCRFs and Medio database
20% domestic travel required
CERTIFICATES, LICENSES, REGISTRATIONS:
ACRP certification preferred
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.