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Job Description Summary

The Clinical Trials Office (CTO) and Protocol Review and Monitoring System (PRMS) Program Manager within the Administration Operations Unit are recruiting for a Program Coordinator to join the team to provide administrative support in a National Cancer Institute (NCI) designated site.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type​

Classified

Cost Center

CC001332 HCC CTO Administration

Pay Rate Type

Hourly

Pay Grade

University-05

Pay Range

39,764.00 - 56,670.00 - 73,576.000

Scheduled Weekly Hours

40

Work Shift

Job Description

Summary:

Under general supervision of the Clinical Trials Office (CTO) and the Protocol Review and Monitoring System manager (PRMS), this position will provide administrative support for the Hollings Cancer Center Protocol Review Committee (PRC) and coverage support for the Data Safety Monitoring Committee (DSMC) as needed. Activities include membership Maintenance and General Scheduling, Data Entry and Reporting, Document Management, and Additional Administrative Support.

Responsibilities:

35% Membership Maintenance and General Scheduling: Under the guidance of the PRMS Administrator, this individual will work closely to complete pre-meeting planning, review tracking, issue tracking, meeting set-up. Receives Approval Step 2 emails and enters PRC meeting dates within OnCore. Assists with quality assurance of the PRC submission portal to ensure all studies submitted have PRC meeting dates entered in OnCore. Sends out calendar invites for PRC and DSMC meetings and reminds members of upcoming meetings. Communicates with members and PRMS administrator as needed to ensure meeting quorum is met. Attend PRC and DSMC meetings and provide administrative support as needed such as running the computer for the meetings. Annually releases the PRC and DSMC meeting calendars. Annually drafts and sends out PRC and DSMC membership letters and track the individual committee member acceptances to serve. Updates committee rosters and communicates updates to the PRC and DSMC chairs. Track membership attendance and annual membership stipends. Assists with scheduling the Bi-Annual PRC accrual meeting and PRMS Retreats as needed.

35% Data Entry and Reporting: Assist the PRMS Administrator with data entry of PRC meeting outcomes within OnCore. Update the PRC portal with post meeting outcomes. Ensures that CTO reports (such as pending projects reports) report accurate study status information. Update OnCore with the Bi-annual Accrual review outcomes for all studies reviewed by the committee. Under the guidance of the PRMS administrator supports quality assurance to verify data accuracy within OnCore and within the TriPS diagrams. Assist the PRMS administrator with the entry of PRMS related statuses and study information within OnCore and other relevant systems.

20% Document Management: Under the guidance of the PRMS Administrator, this individual will work closely to complete pre-meeting planning, draft PRC committee meeting agendas and compile meeting documents. Posts meeting documents to committee portals and follows up on review statuses. This individual may support the PRMS Administrator with post meeting outcome letter drafting and distribution. Works closely with the PRMS administrator to draft amendment outcome letters, distribute to the study teams and save amendment outcome letters within the eReg system. Works to ensure all committee-related study documents and outcome letters are saved within the eReg system. Assists with saving biannual accrual review outcome documents to the eReg system.

10% Additional Administrative Support: May be asked to provide additional coverage for cancer center support grant activities or clinical trial program data entry activities, as requested. May support other quality assurance activities.

Additional Job Description

Minimum Requirements: A bachelor's degree and one-year 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.

Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees