UNIV-Research Lead Study Coordinator-Hollings Cancer Center

Job Description Summary

Reporting up to the Clinical Operations Team Program Manager, the Program Coordinator II
position serves as a study coordinator lead for the multiple Disease Focus Groups within a CTO team. This role is focused on the training, mentoring and day to day supervision of the clinical operation activities within a CTO team.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type​

Classified

Cost Center

CC001332 HCC CTO Administration

Pay Rate Type

Salary

Pay Grade

University-06

Pay Range

46,655.00 - 66,488.00 - 86,321.000

Scheduled Weekly Hours

40

Work Shift

Job Description

35% Serves as study coordinator team lead for all of the DFGs within the assigned CTO team. Under the guidance of the clinical operations team Program Manager, this position will have a primary responsibility focus of overseeing daily clinical operation activities related to clinical trial screening, accrual, and protocol compliance. Meets weekly with the study coordinators to plan for the upcoming week all clinical activities including management of active patients, coverage of DFG investigator clinics, and coverage of HCC meetings and sponsor visits (pre-site, site initiation, monitoring, etc.). While coaching the primary study coordinator, the PCII will ensure that the EPIC research treatment plans are accurate and fit the study patient’s requirements for protocol compliance. Will support the primary study coordinator to ensures that lab, nursing, and other ancillary staff have the correct informational resources such as infusion binder, lab sheets, and correct notes and orders in EPIC to promote protocol compliance and avoid missing or over-ordering of research procedures. The PCII will help forecast coverage activities at any of the MUSC main campus and HCC satellite locations and make necessary coverage plans to avoid interruption of quality CTO services. Must demonstrate knowledge of clinical research procedures and CTO SOPs and show professionalism and competency in providing coverage for study coordination and data management activities within the CTO clinical team.

30% Team Coverage Will provide clinical operational coverage for both the PM and team staff as needed.  When team members are out of office or there are levels of high work volume, this role will be responsible for providing team support. Will serve as a proxy for maintaining employee Kronos approvals and leave approvals and working. Can assist with study feasibility reviews, DFG meeting facilitation, roadmap and lab processing sheet creation, and other clinical operation study start-up tasks, particularly if the team risk being delinquent in completing these start-up tasks by the due-date.  Supports study patient activities, particularly complex visits or satellite location visits when needed. Demonstrates initiative to support to identify risks to poor performance and takes coverage action to help mitigate delinquencies or slow study activation.

30% Training, Quality Assurance and Team Coaching: Assists with the training and coaching study 
personnel in clinical operational activities. Must be knowledgeable of GCP, FDA CFR, and local MUSC and CTO policies and procedures. Utilizes the CTO reference and training tools within the CTO SharePoint to coach team staff member to guide and direct team members. Demonstrates high competencies in clinical operation activities such as protocol screening, informed consent, weekly clinic prep, roadmap development and EPIC treatment plan quality assurance, correlative study management, and data submission to sponsor. Regularly conducts quality checks of team activities and utilizes data delinquency reports, monitoring visits, investigator and provider feedback to identify and implementing new training. Regularly monitors accurate team entry of start-up activity tasks in OnCore and correct entry of subject information in the OnCore clinical calendar and patient enrollment forms. Ensures that screening data is accurately entered in Inteliquet system. May also assess CTO metrics and identify performance trends. Will support the PM and CTO management in various training and process improvement initiative to enhance team performance in time to activation, accrual, and quality. May help the PM in preparation of internal and external audits or evaluating a patient safety incident and may help respond to audit findings and implement corrective and preventative action (CAPA) plans, as applicable.

5% Other duties as assigned. May help study team or CTO leadership in special projects or initiatives. May participate in educational opportunities su