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

Medical University of South Carolina • Charleston, SC

2d • $53,142 - $90,372 • Hybrid

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 Gene Therapy research studies. The role is responsible for all types of submissions required in maintaining Institutional Review Board (IRB) regulations and requirements for various types of clinical trials, maintaining Investigator site files, and study start-up with regulatory, budgeting, and contract processes. The coordinator will guide the collection and entry of data from patient visits, answer queries in the EDC system, and provide education to subjects. They will monitor and train staff on reporting adverse events, and maintain screening, study visits, training, and consent logs. This role also involves mentoring junior staff, facilitating gene therapy procedures (cryo-preservation, apheresis, radiology, fertility banking), and coordinating home health services, transportation, and discharge care for study participants. This position may be eligible for partial remote work after an orientation period.

Requirements

• A bachelor's degree and three years of relevant program experience.
• Ability to perform job functions in an upright position. (Frequent)
• Ability to perform job functions in a seated position. (Frequent)
• Ability to perform job functions while walking/mobile. (Frequent)
• Ability to work indoors. (Continuous)
• Ability to fully use both hands/arms. (Frequent)
• Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent)
• Ability to reach in all directions. (Frequent)
• Possess good finger dexterity. (Continuous)
• Ability to maintain tactile sensory functions. (Continuous)
• Ability to maintain 20/40 vision, corrected, in one eye or with both eyes. (Continuous)
• Ability to see and recognize objects close at hand. (Frequent)
• Ability to see and recognize objects at a distance. (Frequent)
• Ability to determine distance/relationship between objects; depth perception. (Frequent)
• Good peripheral vision capabilities. (Continuous)
• Ability to maintain hearing acuity, with correction. (Continuous)
• Ability to perform gross motor functions with frequent fine motor movements. (Frequent)

Nice To Haves

• Certified Clinical Research Coordinator (ACRP or SOCRA)

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.
• 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.
• 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.
• 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.
• Makes recommendations to investigators and oversite organizations regarding site resources for study teams to help determine site trial feasibility.
• Facilitates, reviews and confirms study budget 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 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.
• Oversees department/unit-wide processes related to research resources and finances.
• Develops systems and documents including process flows, training manuals, and standard operating procedures to be used unit, department, or division-wide.
• 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.
• 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.
• 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 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.
• Serve as a leader to entire department/unit or leads a mentorship program within the department/unit. Defines programmatic vision and direction.
• 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.
• Other duties as assigned

Benefits

• Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level