ProSciento, Inc.

  • CRA Leadership

    Job Location US-CA-San Diego
    Posted Date 1 week ago(10/12/2018 4:46 PM)
  • Overview

    Summary: The (Associate) Director, CRA Services is responsible for management and oversight of monitoring services for ProSciento and its clients. Coordinates with Finance, Budgets and Contracts, and CRO Services staff to ensure adequate resource planning requirements and monitoring logistics, and with third party vendors for acquisition of contract CRAs. Provides oversight of monitoring operational logistics such as resource allocation, scheduling, and training. Leads the management of monitoring staff activities required to conduct clinical trials in accordance with ICH/GCP guidelines, and ProSciento values, policies, and procedures.

    Responsibilities

    Essential Duties and Responsibilities include the following. Other duties may be assigned at the company’s sole discretion.

    • Directs planning and implementation of all activities required to conduct and monitor complex clinical trials, and ensures compliance with GCP, FDA, and other applicable regulations.
    • Responsible for oversight of contracted and full time clinical monitors, including initial qualification, ongoing competency, reassessment at appropriate timeframes, and managing performance.
    • Plans, organizes, and directs operational components required to conduct and complete monitoring of all clinical trials for which ProSciento is contracted for monitoring responsibilities, both for on-site studies as well as multi-site projects.
    • Identifies and oversees resourcing vendors used to acquire contract Clinical Research Associates (CRAs), and approves timesheets using the vendor’s time tracking systems.
    • Assists Clinical Project Management (CPM) staff with issue/query resolutions and CRA performance concerns as needed.
    • Collaborates with key department stakeholders (medical staff, CPMs, Data Management, Clinical Operations, and Quality Management relative to monitoring activities.
    • Writes project-specific monitoring plans and assists CPM with monitoring and study plan development and finalization.
    • Creates, reviews, and approves department Standard Operating Procedures (SOPs) via an electronic document management system.
    • Where needed, performs site qualification visits, pre-study visits, site initiation visits, routine monitoring visits, and close out visits.
    • Implements new processes to enhance monitoring efficiency and, where possible, reduce costs.
    • Coordinates with Budgeting and Contracting and Finance to provide requirements for clinical resources and to perform study budget reconciliation.
    • Monitors CRA expenses and resource utilization during study conduct.
    • Evaluates monitoring quality and provides formal feedback to monitoring staff and Senior Director, CRO Services.
    • Trains monitoring staff. Ensures that all monitoring staff maintain a high level of clinical research monitoring skills appropriate to their role and responsibility.
    • Establishes and tracks monitoring metrics.
    • Participates in department and management meetings.
    • Establishes a standard of excellence in clinical performance and serves as an example of clinical skill requirements, judgment, and responsibility. 

    ☐ Additional Duties and Responsibilities for Director, CRA Services

    All duties defined for Associate Director, and in addition:

    • Continues development of the infrastructure for monitoring services to support clinical trials monitoring across multiple research sites, including international.
    • Develops relationships with resourcing vendors used to acquire contract CRAs on a global scale.
    • Responsible for process improvements to enhance efficiencies, reduce errors, and decrease queries.
    • Develops a full risk-based monitoring system and enhances remote monitoring processes.

    Supervisory Responsibilities:

    Directly supervises CRAs. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and coaching employees; addressing complaints and resolving problems.

     

    Qualifications

    Qualifications:

    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

     

    ☐ Associate Director Education and Experience:

    Bachelor’s degree in healthcare, health or sciences related field, or medical experience e.g. Nurse, Respiratory Therapist, etc. and 8+ years’ related experience; experience in a project management or study coordinator role, and/or clinical experience as a nurse, PA, or Physician Investigator conducting clinical research studies is a plus. Thorough understanding of Good Clinical Practices (GCP) and applicable FDA rules, guidance, and governance as it relates to early phase human clinical trials.

    ☐ Director Education and Experience:

    Bachelor’s degree in healthcare, health or sciences related field, or medical experience e.g. Nurse, Respiratory Therapist, etc. and 10+ years’ related experience including clinical experience as a nurse, PA, or Physician Investigator conducting clinical research studies. Thorough understanding of Good Clinical Practices (GCP) and applicable FDA rules, guidance, and governance as it relates to early phase human clinical trials.

    Language Ability:

    Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

     

    Math Ability:

    Ability to work with mathematical concepts such as probability and statistical inference, as well as possess an understanding of algebraic functions. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

     

    Reasoning Ability:

    Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

     

    Computer Skills:

    To perform this job successfully, an individual should have knowledge of the current Microsoft Office Suite.

     

    Work Environment:

    The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

     

    Physical Demands:

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

     

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