UNIV - SISU Program Manager - Hollings Cancer Center

Job Description Summary

The Clinical Trials Office "Sponsor-Investigator Support Unit" (SISU) is recruiting for a Program Manager.

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-07

Pay Range

57,334.00 - 81,707.00 - 106,080.000

Scheduled Weekly Hours

40

Work Shift

Job Description

Summary:

The Program Manager of the Hollings Cancer Center Clinical Trials Office Sponsor-Investigator Support Unit is responsible for the operational and compliance management of MUSC faculty oncology investigator-initiated clinical trials. This position supports the regulatory, central patient registration, eligibility quality assurance review, and data monitoring of MUSC HCC sponsored clinical trials. The role is critical in providing project management and support to the principal investigator and assuring the trial's success.

Responsibilities:

30% - Project Management
Serves as the primary project manager overseeing study specific operations of trials within the Sponsor Investigator Support Unit (SISU) from trial activation to termination. Administers monthly multidisciplinary operational meetings with the PI, biostatisticians, and study team(s). If operational changes are needed, this role will oversee the revision of all study related documents including the operational manuals. Throughout the duration of the project, assures that the operations are accurately described within the study related documents and manuals and properly communicated to the study teams. Communicates study changes to the assigned biostatistician to ensure that the electronic data capture (EDC) database is updated. Acts as the primary liaison to the PI to record and triage questions regarding protocol conduct and data entry. Supports the PI and team to adhere to requirements within the protocol, Good Clinical Practice Guidelines, and the Code of Federal Regulations. Communicates operational updates to study stakeholders who include, but are not limited to the HCC clinical trials office leadership, institutional review board, investigational pharmacy, the translational science lab, pathology, radiology, etc. Ensures that study documents and manuals are properly posted and tracked within the CTO systems (OnCore, eReg, CTO SharePoint, etc.) and that the study teams are trained on protocol requirements to ensure patient safety. If deficiencies are noted, communicates with sites to identify process improvements and/or re-train on the protocol as needed. Assures accurate accrual information is entered into OnCore and submits protocol information to the PRC for proper registration into the NCI's Clinical Trial Reporting System (CTRP). Will be knowledgeable of clinicaltrials.gov reporting requirements and will coordinate with biostatistics and PRC to ensure that amendments and results are submitted to clinicaltrials.gov within the required timeframes.

30% - Quality Assurance of Study Dataset
Following the Critical Data Management Plan as developed by the biostatistician, this role will support the implementation of the risk-based monitoring plan. Responsible for independently conducting eligibility audits on all subjects enrolled to assigned investigator-initiated trials (IITs) to ensure that all subjects enrolled to the trial are eligible and the source documents support trial eligibility. Maintains an enrollment log for all trials to include subjects enrolled across all participating institutions and will submit to Sponsor-Investigator and/or funding source as required per the study. For randomized trials, retains the randomization model and works with biostatistics to ensure the model is maintained appropriately throughout the life of the trial. Reports subject enrollments for non-MUSC patients in the CTMS system. Reports enrollment milestones to outside funding sources. Acts independently as the sponsor resource for data collection for participating sites. Establishes a data collection and oversight plan (to include CRF completion deadlines and the risk-based monitoring plan) prior to activation and implement the plan while the study is active. Responsible for quality assurance of study specific databases for assigned investigator-initiated trials. Works with investigators and study statisticians to ensure that data collection materials are adequate and collect study endpoint data appropriately. Develops training materials (PowerPoints, video, in-person) and train study team members on how to enter data in the EDC. As the study protocol is amended, notifies the biostatistician to update the electronic data capture system (EDC) as needed. Acts as the primary contact for questions regarding the study database. While the study is ongoing, monitors and source data verifies data entered into the electronic data capture system and identifies trends. Issues queries to the study site regarding any missing and incorrect data and reports any major issues to the local Principal Investigator and Sponsor-Investigator as needed. Tracks case report form submission to ensure data is up to date and entered in a timely manner and will issue a CRF due email to participating centers as needed. Collaborates with the HCC biorepository, HCC CTO Data Core, or other research lab to ensure that study sample collection operations are compliant. As needed, compiles data for reporting to the sponsor-investigator, funding sources and others, as appropriate.

25% - Regulatory Management
After the activation of the investigator-initiated trial and until it’s termination, this position will assume the primary regulatory responsibilities of the portfolio of assigned trials. This includes the proper regulatory submissions to the Institutional Review Board (IRB) and Food and Drug Administration (FDA), HCC Protocol Review Committee (PRC), HCC Data Safety Monitoring Committee (DSMC) and other applicable regulatory agencies. The types of regulatory applications include amendments, protocol deviation, safety reports, and annual renewals per policies and regulations. This position will support drafting study documents and preparing the application and ensuring the submission accurately reflects study conduct and is approved by the Principal Investigator (PI).  This position will also collaborate with the SISU protocol writer to assure an appropriate hand-off of regulatory management such this role has access to review, edit, and maintain the eIRB application, eReg binder, and other document repositories. This position will work with the PI and study teams to understand the project and assure that the regulatory documents are accurate and meet federal and local regulations and policies. Provides coverage for the other SISU studies outside of their primary assignments as needed. Prepares the regulatory binder for any external auditor/DSMC audit review and addresses any regulatory deficiencies found during the audit preparation or receipt of the audit report.

15% - Data Safety Monitoring Committee Reporting
Responsible for the implementation of study specific data safety monitoring plans, which will be used throughout the life of the study to ensure reportable events are submitted to the HCC Data Safety Monitoring Committee (DSMC), IRB and FDA as required. Independently reviews and submits all reportable events to the HCC DSMC, IRB, FDA and other regulatory bodies in the timeframes required. Reportable events include serious adverse events (SAEs), protocol deviations and progress reports. Prior to submitting SAEs and protocol deviations, ensures the report is accurate and complete. Creates progress reports and works with the investigators and study team to ensure the information included is accurate and up to date. Provides synopsis presentations on behalf of the PI to the HCC DSMC. May support DSMC coverage as needed.

Additional Job Description

Minimum Requirements: A bachelor's degree and three years 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 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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