Job Description Summary

Serves as Internal Quality Assurance Auditor and Education Specialist for the clinical operations core of the Clinical Trials office. Primary focus is on education, orientation, and continuous professional development relative to conducting oncology clinical trials. Directly reports to the Program Manager of Quality Assurance and Education, (QAE).

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% Quality Assurance Internal Auditor: Responsible for conducting numerous audits within the Clinical Trials office (CTO) to support protocol compliance. Audits may include, but are not limited to national studies, Phase II, high risk, and potential FDA registration trials. New employee audits will be conducted to focus on subject enrollments to national studies and other non-monitored trials. Internal reviews may be conducted in preparation for NCI National Clinical Trials Network (NCTN) audits, MUSC compliance and or sponsor quality control visits. Internal audit reviews may include the following content areas: informed consent, eligibility, treatment, adverse events, disease response, and data quality. Responsible for completing audit reports using standard report templates in a timely and accurate manner. Communicates findings to QAE Program Manager and enters findings within the clinical trials management system. Application of federal, state, institutional, IRB and CTO regulations and policies is required. Must demonstrate knowledge of FDA, GCPs and ICH regulations. Attention to detail is required and essential for success. Ability to work with minimal supervision and function independently on a daily basis. Must perform as an effective communicator as demonstrated by professional verbal and written communication.

35% Quality Assurance Education Specialist: In tandem with the QAE Program Manager participates in onboarding and training CTO staff on Standard Operating Procedures (SOPs), MUSC IRB policies, Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs), and ICH Guidelines. Within the Clinical Operations unit the focus will be on patient eligibility and safety, data integrity and oncology protocol compliance. Must exhibit knowledge of clinical oncology terminology, study coordination and data management roles, HCC internal workflows, procedures and policies. May confirm subject eligibility for enrollment and complete source documentation verification (SDV) for selected case report form fields to ensure data integrity. Conducts training and education for staff on subject research chart organization, CTSU Open Patient Registration, Medidata Rave, TRIAD, electronic patient-reported outcomes (ePRO), adverse events, response evaluation criteria in solid tumors (Recist), NCI Specimen tracking systems, research compliance, CTO policies and federal guidelines. Approved QAE training documents will be utilized for staff development. Must establish and maintain effective working relationships with HCC and MUSC colleagues. The ability to proactively plan, prioritize and manage responsibilities to ensure patient protocol compliance and data integrity is essential.

20% Quality Assurance Metrics: Within OnCore CTMS is responsible for tracking audits and high-risk monitoring activities. Utilize OnCore, HCC CTO Clinical Data Center, NCI’s RAVE metrics, performance reports, ineligible patient lists, and develops educational tools and training sessions to address areas of non-compliance. Tracks sponsor monitor letters, audit reports and NCI cooperative group performance reports within OnCore CTMS. Reviews upcoming priority sponsor monitor visits and works with clinical teams to ensure activities have been completed prior to the visit. Reviews follow up monitor visit letters and updates findings within OnCore QA forms. Communicates findings and trends with QAE PM to develop quality assurance initiatives that may include process changes, SOP development, and education and training. QAE team collaborates with research teams to update training guidance documents and develop appropriate preventative corrective action plans, (CAPA) as indicated. Consistently exercise judgment and discretion.

10% Quality Assurance Development: Assists the QAE team leadership with special projects and duties to help carry out new initiatives or process improvement pilots. May interact with ancillary services to resolve study concerns. Assess systems and proactively identify potential protocol compliance issues. Initiative to find solutions to promote protocol compliance and staff development. May represent the CTO on MUSC University Committees and or NCTN Cooperative Group Committees. Consistently is a role model for MUSC Standards of Professional Behavior.

MUSC Minimum Training and Experience Requirements:

A bachelor’s degree and three 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 three 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.

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