Job Description Summary

Under general supervision of the Clinical Trials Office (CTO), Manager of Clinical Operations coordinates complex data management activities involving NCI Cooperative group, Investigator Initiated and industry sponsored oncology trials at the Medical University of South Carolina (MUSC). Provides core support for protocol management, patient and data management for oncology research studies conducted at the Hollings Cancer Center. Professional judgment is required regarding patient management and research protocol compliance.

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

$35,360 - $50,395 - $65,429

Scheduled Weekly Hours

40

Work Shift

Job Description

Job Responsibility

35% - Timely and accurately submits data to established research bases including the National Cancer Institute, industry sponsors and MUSC. Maintains subject research charts and submits data for assigned patient caseload. Patient management will include multiple disease programs and protocols. Protocol management will include NCI Cooperative group, Investigator Initiated and industry sponsored oncology trials at the Medical University of South Carolina (MUSC).

35% - Prepares, transports, and handles blood borne pathogens and other biologic specimens following OSHA and IATA guidelines. Collection and submission of pathology specimens and radiology images are submitted to study sponsor at designated time points per protocol. Responsible for laboratory supply kit management including storage and inventory.

15% - Timely and accurately submits Adverse Events and Serious Adverse Events to the NCI, sponsors, our IRB and DSMC per Federal guidelines and institutional policies. Prepares and submits initial and follow up adverse events as required and until resolution of adverse events. Responsible for completion of adverse event and concomitant tracking logs.

15% Participates in staff training and new employee orientation and education regarding data management. Works effectively and cooperatively with colleagues, assists with audits and routine monitor visits. Utilizes office tools including SharePoint, CTMS, Clinical Data Center (CDC), Inteliquet and multiple platforms. Enters and maintains patient status information in CTMS clinical trials database. Ensures timely CTMS Database updates to reflect accurate patient status and links patient visits in EPIC.

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

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

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