M

Medical University of South Carolina

Health sciences university in Charleston, SC

Program Coordinator 2 - Journey, Pediatrics: PRG

Full-TimeUpdated
$53.1k - $90.4k
Mid
Bachelor's
Charleston, SC, USA
In Person
Biology & BiotechClinical Research Operations

About the job

Requirements
  • A bachelor's degree and four years of relevant program experience are required.
  • Ability to perform job functions in an upright position, seated, and while walking or mobile.
  • Ability to work indoors continuously and outdoors in all weather and temperature extremes infrequently.
  • Ability to work in confined or cramped spaces, kneel, squat, perform pinching operations, and use both hands and arms.
  • Ability to perform repetitive motions with hands, wrists, elbows, and shoulders; reach in all directions; and maintain good finger dexterity and tactile sensory functions.
  • Ability to lift, carry, lower, push, and pull objects weighing up to 15 pounds without assistance.
  • Ability to maintain corrected 20/40 vision in one eye or both eyes, recognize objects close at hand and at a distance, determine depth and relationships between objects, and maintain good peripheral vision.
  • Ability to maintain hearing acuity with correction and perform gross motor functions with frequent fine motor movements.
Responsibilities
  • Coordinate and manage clinical trials in compliance with study protocols, regulatory requirements, and Good Clinical Practice guidelines.
  • Complete required submissions to the Institutional Review Board and Institutional Biosafety Committee.
  • Work with the program manager and internal departments to review budgets and contracts.
  • Schedule and conduct protocol-required study visits and assessments, including medical history, surveys, electronic diary device training, electrocardiograms, and concomitant medication review.
  • Collect, process, ship, and maintain inventory of research biological specimens.
  • Ensure timely and accurate data collection following Good Clinical Practice and ALCOA++ guidelines.
  • Collect and report adverse event information as required by protocol.
  • Maintain screening, study visit, training, and consent logs in Investigator site files.
  • Prepare study documentation for routine monitoring visits.
  • Serve as the primary liaison among site staff, sponsors, study vendors, and internal departments involved in clinical research.
  • Mentor junior staff in training and development.
  • Serve as an expert resource for hospital staff performing study-related procedures.
  • Update and maintain internal clinical trial management systems and review EPIC billing charges; coordinate with internal departments to confirm study-related charges and invoiceable items.
  • Synthesize and interpret recruitment reports, assess recruitment strategy effectiveness, implement improvements, and allocate resources to maximize recruitment.
  • Provide oversight and training to the team on subject screening and establish subject-screening systems and policies.
  • Oversee and train study-team members and clinic staff in study-visit preparation, subject-level documentation, and creation of study-level standard operating procedures.
  • Conduct study visits and train others on study-visit conduct, study-level standard operating procedures, and operational plans; perform advanced clinical assessments or interventions and train others on study assessments as needed.
  • Create, optimize, and oversee systems for collecting, preparing, shipping, and maintaining research specimens, and train others in these tasks.
  • Oversee study-team consent processes and documentation; serve as an expert resource and trainer across the department or unit on consent procedures and related documentation.
  • Manage investigational products and oversee study teams' compliance with handling, dispensing, and documentation systems.
  • Create or implement department- or unit-wide policies and procedures for regulatory management.
  • Serve as a department- or unit-wide resource for Institutional Review Board submissions and communications.
  • Create or implement department- or unit-wide policies and guidance for monitoring and audit preparation.
  • Oversee adverse-event collection or provide expert guidance on identifying adverse events; oversee Institutional Review Board safety reporting and serve as a safety-reporting resource.
  • Train staff on reviewing study-participant charges and implementing corrective action plans; ensure research funding is used in compliance with funding-agency protocols.
  • Provide department- or unit-wide oversight of case report forms and data collection quality; create complex case report forms and source documents according to protocol and export data for reporting.
  • Prepare for and lead departmental, unit, or division-wide meetings and mentor junior staff in participating in team efforts.
  • Coordinate efforts and data for external monitoring boards and independently facilitate and submit research data security plans, data safety and monitoring plans, and conflict-of-interest documents.
  • Advise study teams on safeguards for ethical conduct and protection of vulnerable populations.
  • Create department- or unit-level policies and guidance on ethical considerations and conflicts of interest.
  • Participate in departmental committees, task forces, or ad hoc groups and may contribute to presentations or publications.
  • Train staff on work responsibilities, assign responsibilities to junior staff, and provide constructive feedback to team members.
  • Recommend site resources to investigators and oversight organizations to assess trial feasibility.
  • Facilitate, review, and confirm study budgets and invoices for study activities and procedures, including subcontracts and billing.
  • Serve as an internal quality assurance monitor; develop and implement protocol-specific quality assurance plans; conduct site-initiation, interim, and close-out monitoring visits; write monitoring reports; and develop corrective action plans based on visit findings.
  • Oversee department- or unit-wide research-resource and financial processes.
  • Create unit-wide and potentially institution-wide research operations policies, guidance, and plans.
  • Lead or develop and implement policies and guidelines for institutional and other compliance requirements and ensure staff training in risk management; may participate in or lead institutional policy development and training.
  • Perform other duties as assigned.

About the company

M

Medical University of South Carolina

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Medical University of South Carolina is a public academic health sciences university in Charleston, South Carolina. It offers bachelor's, master's, doctoral, and professional degrees through six colleges in dental medicine, graduate studies, health professions, medicine, nursing, and pharmacy.

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