UNIV - Research Program Coordinator II – Advanced - Pediatrics: PRG

Medical University of South Carolina•Charleston, SC

2d•$52,100 - $88,600•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 managing study related procedures for patients enrolled in phase I-IV Gene Therapy 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. Key Duties include: 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. Completing case report forms (CRFs) and answering queries in a timely manner Providing education to subjects in line with protocol requirements. 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 in the event of a sponsor or FDA audit and assisting the auditor for the duration of the audit. Serve as the liaison to external stakeholders. Providing mentorship to junior staff members with areas of training and development. Facilitating necessary procedures required for gene therapy including but not limited to cryo-preservation, apheresis, radiology, and fertility banking. Serve as expert resource for hospital staff performing study related procedures. Coordinating home health services, transportation, and discharge care for study participants on a protocol specific basis. Working with transplant team to coordinate inpatient hospital stays per study requirements including scheduling line placements, bone marrow aspirate/biopsies, and getting appropriate medical clearances.

Requirements

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

Responsibilities

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 team resource and trains others regarding the conduct of study visits, creation of study level SOPs and implementation of operational plans. May perform advanced clinical assessments or interventions and 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.
Prepares for and leads departmental, unit or division-wide meetings. Mentors junior staff to improve ability to participate in team efforts.
Facilitates gene therapy specific coordination with various departments including but not limited to cryo-preservation, apheresis, radiology, bone marrow transplant team, and fertility banking. Implements home health services, transportation, and discharge care for study participants on a protocol specific basis.
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.
Leads a departmental committee, task force, or ad hoc group or participates in institutional committees, task force, or ad hoc group as a subject-matter expert. Leads scientific or programmatic presentations and publications.
Serve as a leader to entire department/unit or leads a mentorship program within the department/unit. Defines programmatic vision and direction.
Makes recommendations to investigators and oversite organizations regarding site resources for study teams to help determine site trial feasibility.
Oversees and is directly responsible for budget development such as translating protocol-specific activities into budget related costs and/or developing external and internal budgets and determining rates of return. May also develop or monitor budget reports, project revenue and expenditures.
Oversees department or unit-wide quality assurance program and ensures corrective action plans are implemented appropriately.
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