University - Research Coordinator II - Journeyman - Pediatrics: Research Group

Job Description Summary

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 Gene Therapy research studies.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type​

Research Grant

Cost Center

CC001014 COM PEDS Clinical Research CC

Pay Rate Type

Salary

Pay Grade

• University-GEN09
• Pay Range

53,142.00 - 71,706.00 - 90,372.000

Scheduled Weekly Hours

40

Work Shift

Job Description

Job Purpose: 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 Gene Therapy research studies.

Is responsible for all types of submissions required in maintaining Institutional Review Board (IRB) regulations and requirements for various types of clinical trials. Responsible for maintaining Investigator site files for all studies. Responsible for study start up with regulatory, budgeting and contract.

Guidance with the collection and entering all data from patient visits, answers query data in the EDC system for various types of clinical trials in a timely manner. Provides education to subjects in line with protocol requirements. Monitors and trains staff focusing on reporting adverse events as required per protocol, maintains screening, study visits, training and consent logs in Investigator site files.

Provides mentorship to junior staff members with areas of training and development regarding IRB submissions, staff training, conducting study visits, training in building relationships with monitors and sponsor/vendor personnel.

Facilitates necessary procedures required for gene therapy including but not limited to cryo-preservation, apheresis, radiology, and fertility banking. Position will also include coordination of home health services, transportation, and discharge care for study participants on a protocol specific basis.

This position may be eligible for partial remote work after an orientation period.

Duties:

Research Operations Research Visits-30%

Recruitment: Synthesizes and interprets recruitment reports to assess effectiveness of recruitment strategies and implements innovative solutions to maximize recruitment strategies by allocating resources appropriately.

Screening: Provides oversight and training to entire team unit with regards to subject screening. Establishes systems and policies related to subject screening.

Study visit preparation and documentation: 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.

Conduct study visits: 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.

Specimen collections: Creates, optimizes, and oversees systems to collect, prepare, ship, and maintain inventory of research specimens and trains others on these tasks.

Informed consent: 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.

Investigational Products: Assists with management and tracking of IP at the protocol and subject level. Employs the required system for handling, dispensing, and documentation of IP for sponsored protocols. May be responsible for determining the best methods for handling & documenting IP for investigator-initiated protocols and coordination with investigational pharmacies as necessary.

Regulatory management: Responsible for creating and/or implementing policies and procedures related to department/unit-wide regulatory management.

Interactions with IRB: Serves as a department/unit-wide resource for the development of IRB submissions and for guidance on IRB communications.

Preparation for study monitoring/audit visits: Responsible for creating and/or implementing department/unit-wide policies and guidance related to monitoring and audits.

Adverse event collection and safety reporting: Oversees adverse event collection or provides expert guidance on identifying adverse events.

Safety Reporting: Oversees the IRB safety report documentation for the entire department or unit. Serves as a resource to department, unit, or division on safety reporting.

Billing Compliance: 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.

Site and Study Management-25%

Trial Feasibility: Makes recommendations to investigators and oversite organizations regarding site resources for study teams to help determine site trial feasibility.

Budgeting and Financial Management: Facilitates, reviews and confirms study budget and/or study invoices for study related activities and procedures including sub-contracts and billing.

Quality Assurance : Serves as an internal Quality Assurance Monitor and develops and implements protocol specific program quality assurance plans. Conducts site-initiation, interim and close-out monitoring visits, writes monitoring reports, and develops corrective action plans related to visit findings.

Managing Resources: Oversees department/unit-wide processes related to research resources and finances.

Operational Plans: Develops systems and documents including process flows, training manuals, and standard operating procedures to be used unit, department, or division-wide.

Managing Risk: 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.

Communication-15%

Communication with sponsors, sites, CROs & Teamwork: Prepares, participates, and/or leads team meetings. Takes an active role in decision-making. May be responsible for trouble-shooting issues and communicating with other team members accordingly. Acts as an expert resource to junior staff liaising with sponsors, subcontractors, vendors or ancillary services.

Gene Therapy Specific Communications: 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.

Data and Informatics-10%

Data Entry: Serves as a departmental/ unit-wide resource on CRFs, provides oversight to ensure highest quality data collection and capture.

Data Coordination: Creates complex data collection forms (CRFs and/or source documents) according to protocol. Exports data to include reporting of data.

Leadership and Professionalism-10%

Management and mentorship: Serve as a leader to entire department/unit or leads a mentorship program within the department/unit. Defines programmatic vision and direction.

Ethics and Participant Safety-5%

Safety Plans: 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.

Implementation of Human Subjects Protections: Serves as an expect resource to study teams as they design studies, so they specif