University of South Florida-posted about 13 hours ago
Full-time • Mid Level
Tampa, FL
5,001-10,000 employees

This position plans, organizes, and manages the resources necessary to achieve clinical research project goals and objectives. The position assembles, trains and manages the team assigned to the project. The position documents procedures for the research project and manages reporting and compliance activities, serving as the overall head of project operations. Nature of Work: This position typically reports to the principal investigator of a clinical research study or to an administrator, such as an Assistant Director who oversees many projects. The position may develop protocols and prepare operations manuals at the initiation of a research study. The position then performs project activities such training and indirectly (or directly) supervising project staff, developing materials to communicate the project to potential clients and their families, making site visits to audit activities, ensuring quality control in the data through resolution of inconsistencies, and compiling regulatory reports. The position acts as the primary resource for explaining the project all parties involved. Work at this level meets the FLSA criteria for a professional exemption since the primary duties are work that requires advanced knowledge which is predominantly intellectual in character and requires the consistent exercise of discretion and judgment. Sr. Clinical Research Associates typically oversee staff who are assigned to the project but may not directly supervise. Sr. Clinical Research Associates do not set overall project direction nor do they have responsibility for final interpretation of project results. This position may perform some general administrative duties such as monitoring budgets, and drafting administrative forms and reports, but the primary purpose is to oversee and conduct the principal project activities.

  • Oversees and designs protocols and electronic case report forms.
  • Develops manual of operations.
  • Reviews medical protocol and prepares draft of document.
  • Coordinates with protocol project manager and study chair preparation of final document for research staff training.
  • Updates the protocols as needed and maintain document version control.
  • Throughout the tenure of the medical protocol, update as needed with Study Chair as appropriate.
  • Trains indirect and/or direct reports on policies and procedures, operations, adverse event resolution, protocol creation and review, case report form creation and review, and site data adherence and compliance.
  • Monitors compliance of study procedures with Federal, state and university regulations.
  • Ensures that documents such as eligibility forms and informed consent are appropriately gathered and maintained, HIPAA regulations are followed, and that infection control, and safety procedures are implemented.
  • Manages addition of new sites to the network and develops and maintain policies, templates, and related documents for new site additions.
  • Develops and interprets policy governing data systems, data collection procedures and database validation studies to be in compliance with federal guidelines (Good Clinical Practice, GCP).
  • Collects and analyzes data from clinical trials or other medical screening.
  • Creates data bases based client information or medical records, and analyzes data.
  • Coordinates conference calls and meetings and prepare necessary meeting documents (agendas, minutes, handouts, reports, etc.), develops related standards, templates and processes.
  • Acts as point of contact and support for consortia research staff.
  • This position requires a Bachelor's degree in a field directly related to the program responsibilities and three years of professional experience; or Master's degree in an area of specialization appropriate for the program and one year of professional experience.
  • SB 1310: Substitution of Work Experience for Postsecondary Education Requirements A public employer may include a postsecondary degree as a baseline requirement only as an alternative to the number of years of direct experience required, not to exceed: (a) Two years of direct experience for an associate degree; (b) Four years of direct experience for a bachelor’s degree; (c) Six years of direct experience for a master’s degree; (d) Seven years of direct experience for a professional degree; or (e) Nine years of direct experience for a doctoral degree
  • Related work experience may not substitute for any required licensure, certification, or registration required for the position of employment as established by the public employer and indicated in the advertised description of the position of employment.
  • Ability to work independently and in a group setting.
  • Creative problem solver, ability to manage tight deadline, impeccable time management, and excellent verbal and written communication
  • PREFERRED: Bilingual- Spanish.
  • Certified in Clinical Research with a reputable clinical research society.
  • Master's degree in Biological Science, Public Health, Health Science, Nursing or other directly related field.
  • RN, State of FL.
  • Phlebotomy trained.
  • Experience in REDCAP, EPIC, eBinder software (FLORENCE) or data management/Clinical Research tracking software.
  • Prior management experience preferred.
  • SPECIAL SKILLS/TRAINING
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service