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

Job Duties

35% Daily Clinical Operations Team Supervision: 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% Special Projects as assigned: May help study team or CTO leadership in special projects or initiatives. May participate in educational opportunities such as supervisory trainings and human resource management. May serve in special committees in HCC, MUSC or externally

MUSC Minimum Training and Experience Requirements:

A bachelor’s degree and two years of relevant program experience.

MUSC Physical Requirements:

(Note: The following descriptions are applicable to this section: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift)

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 work outdoors in all weather and temperature extremes. (Infrequent)
Ability to work in confined/cramped spaces. (Infrequent)
Ability to perform job functions from kneeling positions. (Infrequent)
Ability to squat and perform job functions. (Infrequent)
Ability to perform ’pinching’ operations. (Infrequent)
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 lift and carry 15 lbs., unassisted. (Infrequent)
Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted. (Infrequent)
Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent)
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)

Additional Job Description

Minimum Requirements: A bachelor’s degree and two years of relevant program experience. Physical Requirements: (Note: The following descriptions are applicable to this section: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift) 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 work outdoors in all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform job functions from kneeling positions. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to perform ’pinching’ operations. (Infrequent) 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 lift and carry 15 lbs., unassisted. (Infrequent) Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) 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)

If you like working with energetic enthusiastic individuals, you will enjoy your career with us!

The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need.

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