San Jose based Visby Medical is an ambitious, well-funded, and fast-paced early stage biotech startup. Driven by a belief that disease diagnosis should be quick, accurate, and accessible to all, Visby is developing a novel diagnostic device platform that aims to redefine the way an infectious disease is tested and treated.

We are developing a tenacious team with deep industry expertise of researchers, biologists, designers, and engineers that is back-stopped by world class operations and administrative resources. If you enjoy tackling challenging problems, are passionate about your work product, and want to join a collaborative ownership team that is aiming to leave a lasting positive legacy in the healthcare industry, please consider the following Senior Clinical Research Associate opportunity.

Summary

This Sr. Clinical Research Associate (Sr. CRA) role reports to the Manager – Monitoring and Study Support within Clinical Operations and works closely with the Clinical Group to design, plan, and implement the overall direction of clinical study projects. The primary responsibility is to assist the study team with all operational activities for new and/or on-going clinical studies. Additionally, the Sr. CRA will provide key support in oversight of study start-up activities, implementation, monitoring, and close-out activities of multiple clinical trials and process-improvement activities. The Sr. CRA works with clinical project team members, vendors, and CRO CRA teams to assure that protocol requirements, regulatory guidelines and study timelines are defined and met. This position will review relevant study documents, trip reports, monitoring trends, track monitoring deliverables, and recommend potential solutions to identified issues.

Essential Duties

Major responsibilities:

  • Independently responsible for all activities of the clinical trial
  • Support clinical monitoring activities to help ensure the safety and well-being of study participants/patients at clinical site(s)
  • Act as primary liaison for assigned study sites to convey project information and ensure site(s) compliance with study protocols, plans and guidelines, Good Clinical Practices (GCPs), and applicable regulations
  • Oversight of the source data verification and monitoring process and/or remote monitoring to help ensure data integrity.
  • Involved in development and review of study documents, (e.g. protocol, CRFs, informed consent forms, manuals, laboratory manuals, vendor manuals [not all inclusive]).

Monitoring Responsibilities:

  • Independently responsible for all activities of all types of clinical monitoring visits, (e.g. qualifications, initiations, on-site and remote monitoring, and close-out) which includes all preparatory and follow-up aspects.
  • Monitors site performance and compliance and provide management with necessary reports, updates and recommendations
  • Assists CRAs, sites and data management with data query resolution
  • Trains site personnel on sponsor and regulatory requirements for study conduct; participates in Investigator Meetings.
  • Conducts site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with study plans, GCPs, and applicable regulations
  • Prepares and/or reviews monitoring visit reports and associated documentation
  • Coordinates preparation of responses to regulatory agencies’s questions re: the clinical study 
  • Reviews on-site files and records, Case Report Forms, and source documents for completeness, accuracy, consistency, correctness and compliance; identifies deficiencies and discrepancies; initiates corrective action as required; and ensures training is provided within a reasonable timeframe, is current, and is documented appropriately
  • Advises and trains newly hired CRA or juniors and direct others in the completion of tasks and projects. 
  • Ensures appropriate and timely transmission of clinical data to the data management centers; timely review of data queries, and proactive preparation for interim or final data base lock activities. Works with the CRAs to keep TMF audit-ready during the entire course of the study
  • Ensures timely site close-out visits including identifying issues to be resolved in timely manner, assures Essential Documents, data and other study related materials are in place and completed and prepares site close-out reports
  • Supports and reviews site data quality trends via trip reports and data review including queries and protocol deviations
  • Supports preparation and may develop materials related to the training and presentations for CRA training, Site Initiation Visits and Investigator Meetings
  • Develops and writes Clinical Monitoring Plans, study protocols, case report forms, informed consents, and other required documents for clinical studies.
  • Identifies and qualifies clinical investigators and sites
  • Prepares clinical reports and clinical/non-clinical sections of regulatory submissions and prepares scientific abstracts, posters and publications arising from clinical trials.
  • Proposes and negotiates budgets for clinical studies
  • Reviews invoices received from sites and maintains and accurate accruals 
  • Arranges for and assists Statistical Support with the collection and statistical analyses of clinical data
  • Assists with the management of key study parameters (i.e., start-up activities, enrollment, data collection, etc);
  • Supports review of or develops monitoring tools
  • Demonstrates good presentation skills and understands changes in work tasks, situations, and environment as well as the logic or basis for change
  • In conjunction with Clinical Development/Operations leadership and vendor, develops and tests EDC (if applicable)
  • Provides a key role in problem solving and issue escalation, regarding monitoring issues, with proposed solutions to the Clinical Manager

Primary Non-QMS Responsibilities:

  • Performs other duties and projects as assigned 
  • Approximately 25-40% travel is required
  • Assists Clinical Operations in inspection readiness activities

Education and/or Experience

  • Requires a minimum of five (5) years’ experience in clinical study coordination, clinical site monitoring or clinical study management. Sponsor in-vitro diagnostics experience preferred.
  • Bachelor degree in scientific discipline or related field required, or equivalent combination of education and work experience.

Minimum Requirements

  • Prior experience with current Good Clinical Practices (cGCP) and Code of Federal
  • Regulations (CFR) is preferred.
  • A background in biomedical/healthcare services with laboratory experience preferred.

Skills & Experience:

  • Highly organized and detail-oriented
  • Critical thinking abilities
  • Computer literate
  • Strong problem-solving abilities.
  • Excellent written and verbal communication and time management skills
  • Excellent understanding of the clinical research process, clinical trial-related systems and procedures, regulations and GCPs
  • Scientific/clinical knowledge to be able to understand the nature of the laboratory assays being studied
  • Must have excellent people skills and demonstrate the ability to work successfully in a team environment
  • Ability to prioritize and to manage multiple tasks as necessary
  • Ability to work in a team as well as independently, and to manage multiple priorities with minimal support in a fast pace environment
  • Start-up experience preferable

Other Qualifications 

  • Computer software skills (MS Word, Excel, Outlook, PowerPoint, and Access experience)
  • Strong communication and presentation skills
  • Strong attention to detail, self-motivation, and good time management & organizational skills
  • Ability to multi-task and ability to work both as part of a team and independently
  • Proactive approach, with high sense of urgency and results orientation.
  • Progressive thinker, innovative and open-minded.
  • High levels of integrity, intellectual honesty and maturity
  • Knowledge of GDA requirements for clinical validation and CLIA waiver
  • Knowledge of FDA, ICH, and GCP requirements

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