Job Description Summary

The Sponsor Investigator Support Unit (SISU) provides clinical research organization services to HCC faculty who led single-center and multi-center treatment investigator-initiated trials (IITs) at MUSC and nationally. The SISU Administrative Director role requires knowledge in FDA regulations and ICH Good Clinical Practice to ensure that HCC IITs are conducted in the highest quality and compliant manner that protects patient safety and data integrity. In collaboration with the scientific director and the HCC CTO leadership, the SISU Administrative Director will lead and mentor a team of CRAs who facilitate the development and successful completion of HCC-driven IITs from concept to close-out.

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-09

Pay Range

83,219.00 - 118,596.00 - 153,973.000

Scheduled Weekly Hours

40

Work Shift

Job Description

35% HCC IIT Portfolio Project Management: This role will work with the HCC’s Research Programs and clinical leaders in the development and completion of all HCC-driven investigator-initiated treatment trials and other IITs managed by the HCC CTO. He/she will serve as the administrative chair of the Hollings Advisory for Rapid Translation (HART), which is an executive board of the Hollings Cancer Center that oversee the trial pipeline of clinical trials derived from HCC members and HCC science. The role will lead the SISU teams to provide efficient and high-quality activation services and sponsor maintenance activities. The SISU Administrative Director will track all IIT projects, monitor performance metrics, and effectively address or escalate issues to HCC’s executive leadership. He/she must know clinical trial operations standards, budget development and research finance billing compliance, and local IRB, DSMC, and FDA policies and procedures. Project management skills are required to track all SISU procedures from concept to completion. Effective and professional communication skills are needed to work across the MUSC enterprise, industry sponsors, and IIT academic sub-sites across the country. Participates within the HCC Translational Cancer Teams and Disease Focus Groups to represent the CTO and learn and support the creation of new clinical trial ideas. Shares findings with the CTO Director and assists in presenting information and initiatives at that Clinical Research Executive Committee, HCC Leadership meetings and monthly HCC Research Program meetings.

35% SISU Fiscal and Administrative Management: The SISU operating budget is approximately $1 million annually and the team manages a growing portfolio of IITs study accounts of multicenter and single center early phase clinical trials. The SISU Administrative Director must demonstrate skills to effectively develop IIT study budgets and review and negotiate contract language (in collaboration with MUSC central contract office). He/she will assist clinical researchers in developing proposals for external and internal trial funding and provides program management to investigators developing new investigator-initiated research letters of intent or grant applications. In collaboration with the SISU scientific director, he/she will communicate trial-specific and program needs to stakeholders within MUSC and external stakeholders such as pharmaceutical sponsors, biotech companies and potential philanthropic donors or HCC advisory board members in efforts to secure the essential resources for IIT implementation. The position will oversee the SISU fiscal activities of the HCC CTO pre-award coordinator to ensure that every IIT is set-up with the proper research billing compliance standards such as a prospective reimbursement analysis and research billing grid. When external service agreements are needed for the completion of an IIT activities (e.g. drug distribution, lab analysis, etc.), this role will support the PI in overseeing the procurement and budget management of the professional services. This position will also work closely with the CTO finance manager and post-award team, or the PI’s grant administrator to ensure that funding partners IITs are properly invoiced and any annual NIH progress report is completed. External peer review grant management knowledge will be essential to support the PI in developing NIH draft budgets and supporting the PI in the completion of grant reporting requirements.

25% SISU Program Development: Program development responsibility will span human resource responsibilities, quality assurance, and continuous process improvement and strategic planning. As the SISU supervisor, he/she will support position SISU hiring, performance evaluation, mentorship and education. This role will work with the coordinators and, as applicable, other University departments to develop policy and procedures and adjust SOPs as new directives or system changes apply. He/she will support and maintain training of SISU employees and sponsor-investigators. He/she will create and support a quality assurance program for SISU clinical research activities. With minimal supervision, he/she will monitor non-compliance with national performance benchmarks and relevant local and federal regulations and identify areas for improvement and implement strategies for corrective actions. In collaboration with the CTO, IRBs, Office of Clinical Research, and other institutional partners, this role will assure that SISU policy and procedures meet the HCC DSMP and other applicable federal and local regulations. It will be important to stay abreast of IIT program service trends among other NCI Designated cancer centers and develop strategic plans to enhance the SISU program. He/she will also work with HCC leadership to ensure that strategies are in place to promote robust growth and productivity of the HCC IIT portfolio.

5% Special Projects and Additional Duties: Provide project management of special activities and other duties as assigned.

Bachelor's Degree; Preferably Masters. Prefer prior oncology clinical research experience, particularly in regulatory.

MUSC Minimum Training and Experience Requirements:

A bachelor's degree and five years relevant program management experience.

Additional Job Description

Minimum Requirements: A bachelor's degree and five years relevant program management 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 lift objects, up to 15 lbs., from floor level to height of 36 inches, 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 match or discriminate between colors. (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 hear and/or understand whispered conversations at a distance of 3 feet. (Frequent) Ability to perform gross motor functions with frequent fine motor movements. (Frequent) Ability to work in dusty areas. (Infrequent)

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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