UNIV - SIS Unit Program Coordinator II - Hollings Cancer Center (INTERNAL APPLICANTS ONLY) Job no: 511465 Entity: MUSC University Department: ACADEMIC AFFAIRS - Hollings Cancer Center Sub Department: UNIV-2101020-HCC Clinical Trials Office Work type: Full-Time Employee Type: UNIV - Classified Location: Charleston, SC Categories: Clinical Trials, Research Pay scale: UNIV-Band 6: $39,960.00 - $56,947.00 - $73,935.00 (min - mid - max) Job Duties: 10In collaboration with the SISU Regulatory Coordinator, ensures PRC, IRB and FDA submissions are accurate. Coordinates with the SISU Regulatory Coordinator to develop the informed consent form, patient materials and other regulatory documents as needed. Assists in the compilation of FDA IND annual reports, including, but not limited to, providing relevant data (AEs, SAE, patient status and patient demographics). Provides coverage for the SISU Regulatory Coordinator as needed.Essential 15Responsible 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 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.Essential 25Acts as the primary liaison with the study teams and ancillary services at each participating center for questions regarding protocol implementation and data entry to ensure the study is implemented as required per protocol, Good Clinical Practice Guidelines, and the Code of Federal Regulations. Ancillary services include, but are not limited to investigational pharmacy, the translational science lab, pathology, radiology, etc. Ensures 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. Submits protocol and accrual information into the NCIs Clinical Trial Reporting System (CTRP). Will be knowledgeable of clinicaltrials.gov reporting requirements and will coordinate with biostatistics to ensure results are submitted to clinicaltrias.gov within the required timeframes. Partners with the translational science lab to ensure the study lab manual is drafted prior to study activation and meets the needs of the study and participating centers. Ensures samples are received and acceptable; if not, coordinates appropriate trainings for process improvements. Collaborates with investigational pharmacy and drug provider to develop pharmacy manuals. Develops study specific operations manual to detail how to submit data, reportable events and general regulatory requirements for each participating center.Essential 25Acts 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 developing 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, updates 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. As needed, compiles data for reporting to the sponsor-investigator, funding sources and others, as appropriate.Essential 25Responsible for the development and 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 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. In preparation for HCC DSMC internal audits, works with sites to ensure data is up to date and accurate and identifies areas needing to be addressed prior to the audit. Works with sites to submit the required documents and/or access needed so the audit can be conducted and ensures the auditors have appropriate access to the databases and source documents needed to conduct the audit. If deficiencies are identified as part of the audit, communicates the issues to sites, assists in addressing the issues, and develops corrective action plans, and/or implements corrective action plans.Essential Job summary: Under the guidance of the CCSG Program Manager, this individual will work closely to oversee the study and site management of Investigator Initiated Trials (IITs) being conducted at Hollings Cancer Center. HCC IITs may be single center or multicenter. The purpose of this role is to ensure that HCC IITs are prepared and implemented according to Good Clinical Practice guidelines and federal, state, and local requirements at all participating locations. This individual will conduct administrative duties associated with the sponsor responsibilities of HCC IITs, including but not limited to: scientific review, IRB and FDA submissions (including initial submissions and study updates as applicable); case report form/electronic data capture system development and updates; data monitoring and quality assurance activities; data safety monitoring plan development and implementation. This individual will work closely with departments across campus who are involved with developing or conducting HCC IITs and other NCI designated cancer centers in the US. ------------ Payscale Salary Range: UNIV-Band 6: $39,960.00 - $56,947.00 - $73,935.00 (min - mid - max) ------------ FLSA: Salaried ------------ Minimum Experience and Training Requirements: A bachelor's degree and two years relevant program experience. ------------ Physical Requirements: 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 20/20 vision, corrected. (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) Opening date: 04 Jan 2019 Eastern Standard Time Applications close: 11 Jan 2019 11:55 PM Eastern Standard Time