Job Description Summary

Under general supervision of the Clinical Trials Office (CTO), Manager of Clinical Operations, coordinates, establishes, and supervises complex research protocols at the Hollings Cancer Center (HCC) to efficiently and effectively integrate cooperative group and industry sponsored trials at the Medical University of South Carolina (MUSC). Actively promotes and increases
awareness of the clinical trial program within HCC, exercises judgment regarding proper patient management, timely and accurately meets established reporting systems to research bases, National Cancer Institute, and MUSC staff.

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

35% Screens all patients at the Hollings Cancer Center that have been newly diagnosed, have progressed or experienced a recurrence for possible inclusion into an active clinical trial. Informs potential patients on study specifics, coordinates initial protocol procedures/ treatment plan and ensures required follow up procedures. Ensure protocol compliance for study patients. Ensures database updates to reflect accurate patient status. Utilizes office tools including Sharepoint, Clinical Data Center (CDC) Inteliquet and CTMS.

30% Timely and accurately collects and submits data to specified research
bases. Ensures data quality and timely completion and submission of case
report forms and queries by establishing effective daily routines and
processes.

20% Timely and accurately submits Serious Adverse Events to sponsor, IRB and DSMC per institutional policies. Prepares and submits CTO-required and sponsor specific initial and follow up reports.

10% Participates in Trial Start up process for new studies. During the “In Approval Process-Step 1” reviews new protocols, completes the Initial Roadmap submission by designated timeline and obtains study specific credentialing per protocol requirements. As protocol amendments are received Amended Roadmaps are
completed per assigned due date to ensure patient safety.

5% Attends and actively participates in Disease Specific Focus Group Meetings.
Presents pertinent research related data to program leader and individual
investigators. Maintains up to date protocol information, communication and
education of study and clinic personnel. Assists in planning, implementing, and
evaluation of program expansion and new projects.

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