UNIV - Program Coordinator II - Journey - Pediatrics: PRG

Medical University of South Carolina•Charleston, SC

4d•Onsite

About The Position

This position is for a Program Coordinator II that is under the direction of the Program Manger assuming responsibility and accountability in providing management of study related procedures for patients enrolled in phase I-IV clinical trials. This position is responsible for coordinating and managing clinical trials, ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.

Requirements

A bachelor's degree and four years of relevant program experience.

Responsibilities

Completing required submissions to the Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC).
Working alongside the program manager and other internal departments to review budgets and contracts.
Scheduling and conducting study visits and assessments per protocol; including but not limited to medical history, survey administration, ediary device training, ECGs, concomitant medication, etc.
Collecting, processing, shipping, and maintaining inventory of research biological specimens
Ensuring timely and accurate data collection following GCP and ALCOA++ guidelines
Collecting and reporting adverse events information as required per protocol
Maintaining screening, study visits, training and consent logs in the Investigator site files.
Preparing study documentation for routine monitoring visits.
Serving as the primary liaison between site staff, sponsors, study vendors and other internal departments involved in the conduct of clinical research
Providing mentorship to junior staff members with areas of training and development.
Serve as expert resource for hospital staff performing study related procedures.
Update and maintain internal CTMS systems and review EPIC billing charges.
Work alongside internal departments to confirm study-related charges and invoiceable items.
Synthesizes and interprets recruitment reports to assess effectiveness of recruitment strategies and implements innovative solutions to maximize recruitment strategies by allocating resources appropriately.
Provides oversight and training to entire team unit with regards to subject screening. Establishes systems and policies related to subject screening.
Provides oversight and training to study team members, including clinic staff, regarding preparation of study visits, maintenance of subject level documentation and creation of study level SOPs.
Serves as a departmental/unit resource and/or trains others regarding the conduct of study visits, creation of study level SOPs and/or implementation of operational plans. May perform advanced clinical assessments or interventions and/or trains others on study assessments.
Creates, optimizes, and oversees systems to collect, prepare, ship, and maintain inventory of research specimens and trains others on these tasks.
Provides oversight (to include review) to study team members who conduct and document consent for participants in a variety of studies. Serves as an expert resource and trainer across department or unit on the consent process and related documentation.
Responsible for the management of IP. Oversees and serves as an expert resource for study teams on the implementation of and compliance with required systems for IP handling, dispensing and documentation.
Responsible for creating and/or implementing policies and procedures related to department/unit-wide regulatory management.
Serves as a department/unit-wide resource for the development of IRB submissions and for guidance on IRB communications.
Responsible for creating and/or implementing department/unit-wide policies and guidance related to monitoring and audits.
Oversees adverse event collection or provides expert guidance on identifying adverse events.
Oversees the IRB safety report documentation for the entire department or unit. Serves as a resource to department, unit, or division on safety reporting.
Serves as a resource and trains other staff on reviewing study participant charges and implementing corrective action plans. Ensures that the use of research funding is in compliance with funding agency protocols.
Serves as a departmental/ unit-wide resource on CRFs, provides oversight to ensure highest quality data collection and capture.
Creates complex data collection forms (CRFs and/or source documents) according to protocol. Exports data to include reporting of data.
Prepares for and leads departmental, unit or division-wide meetings. Mentors junior staff to improve ability to participate in team efforts.
Coordinates efforts and data for external monitoring boards and independently facilitates and submits the completion of documents related to Research Data Security Plans, Data Safety and Monitoring Plans, and Conflict of Interest.
Serves as an expect resource to study teams as they design studies, so they specifically include safeguards to ensure ethical conduct and protection of vulnerable populations.
Creates policies and guidances at the department/ unit-wide level regarding ethical considerations.
Takes part in a committee, taskforce, or ad hoc group within a department. May participate in presentations and/or publications.
Trains staff on various work responsibilities and assigns responsibilities to junior staff. Provides constructive feedback to team members.
Makes recommendations to investigators and oversite organizations regarding site resources for study teams to help determine site trial feasibility.
Facilitates, reviews and confirms study budgets and/or study invoices for study-related activities and procedures including sub-contracts and billing.
Serves as an internal Quality Assurance Monitor and develops and implements protocol specific quality assurance plans. Conducts site-initiation, interim and close-out monitoring visits, writes monitoring reports, and develops corrective action plans related to visit findings
Oversees department/unit-wide processes related to research resources and finances.
Creates unit-wide, and may collaborate to create institution-wide, policies and guidances regarding research operations and plans.
Responsible for or leads the development and/or implementation of policies and guidelines related to compliance with institutional requirements and other policies. Also ensures appropriate training of all staff related to risk management. May also participate in or lead policy development and/or provide training at the institutional level.
Other duties as assigned