Job Description Summary
Under general supervision of and collaboration with the Data Core Program Manager, the Data Coordinator Lead position will mentor other data managers and coordinators that will oversee patient data for patients enrolled to clinical trials managed by the HCC CTO. The types of data include follow-up patient data and as needed some more complex on-study patient data. Data management activities involve NCI Cooperative group, Investigator Initiated and Industry sponsored oncology trials and professional judgment is required regarding patient management and research protocol compliance.
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% - Unit Development and Strategic Planning- In collaboration with the Data Core Manager, this position will support the identification and implementation of new initiative to streamline and increase efficiencies of data management activities. This position will help develop strategic plans for the creation of a centralized data management core within the CTO. This may involve the creation and maintenance of new training and process guides for data management and implementation of corrective action plans related to data underperformance or deficiencies. Participates in staff training and new employee orientation and education regarding data management. Works effectively and cooperatively with colleagues, assists with audits and routine monitor visits. Will work closely with the Data Core Manager and Quality Assurance and Education unit to onboard new clinical operations staff to develop data management skills. Will review data management performance metrics and proposed new initiatives to leadership
30%- Data Management Support Timely and accurately submits data to established research bases including the National Cancer Institute, industry sponsors and MUSC. Maintains subject research charts and submits data for assigned patient caseload. Patient management will include multiple disease programs and protocols. Protocol management will include NCI Cooperative group, Investigator Initiated and industry sponsored oncology trials at the Medical University of South Carolina (MUSC). Interprets protocols, informed consents and case report forms to develop and use study related forms, data, calendars and documents according to accepted clinical trials professional standards. Meticulous data management is required for assigned studies and patient caseload. Chart abstraction, timely submission of data forms, retrieval of data (includes calling outside M.D.s and hospitals), admission records, clinic visits, and all source is required. Maintenance of research subject records and case report forms is essential. Case report submission may include QOL surveys, radiologic scans, reports and staging tests. Proactively plan, prioritize, and manage responsibilities to ensure timely and accurate data submission to specified research bases. Data submission is timely and accurate per the protocol, patient calendar, and source documents. Ensures data is submitted according to sponsor mandated time frames and in a manner that affords maximum accuracy. Data submission will include query resolution, and adverse event and concomitant medication logs. Ensures source documentation is located within patient research chart for source documentation verification. Visit-specific CRFs are to be completed per sponsor requirements.
25% - Prepares, transports, and handles blood borne pathogens and other biologic specimens following OSHA and IATA guidelines. Collection and submission of pathology specimens and radiology images are submitted to study sponsor at designated time points per protocol. Responsible for laboratory supply kit management including storage and inventory. May support these activities for patients seen at HCC satellite locations in East Cooper and North Charleston.
Responsible for preparing kits for each patient and ensuring collection and shipment per Federal guidelines. Prepares and ships frozen and ambient specimens, including central labs, Pharmacokinetic and Pharmacodynamics. Preparation includes professional communication and collaboration with colleagues, Nexus SCTR services, translational, fast flow and phlebotomy labs to facilitate protocol compliance. Completes required specimen submission case report forms, protocol specific shipping procedures and enters specimen tracking data on designated NCI and or sponsor vendor website including CTSU OPEN. Participates in training and in-servicing for NEXUS and Fast Flow laboratory personnel on research protocols for multiple programs. Obtains IROC radiologic credentialing as required per sponsor prior to study activation. This may include radiologic surveys and phantom scan submissions. Responsible for the transmitting of all required Radiology scans and or EKGs per the protocol and the sponsor. Responsible for addressing queries from the vendors and working with MUSC radiology staff as needed to resolve any queries. Responsible for the laboratory supply kits (outside vendors) including receiving and maintaining inventory. Responsible for reviewing lab manuals to identify any barriers and completion of required lab worksheets. Responsible for conducting NEXUS in-service training on study specific lab processing for assigned protocols.
10% - Timely and accurately submits Adverse Events and Serious Adverse Events to the NCI, sponsors, our IRB and DSMC per Federal guidelines and institutional policies. Prepares and submits initial and follow up adverse events as required and until resolution of adverse events. Responsible for completion of adverse event and concomitant tracking logs. Coordinates the reporting of adverse events and serious adverse events based on the NCI Common Toxicity Criteria, (CTC) and protocol requirements. Adverse events are submitted for multiple disease programs on multiple studies. Data is submitted to various sponsors, research bases, FDA & the local IRB as per institutional policies. Reporting timelines within the Clinical Trials Office, IRB and study sponsors are met for reporting. Proactively plans to ensure reports are comprehensive and that reporting requirements are met within the allowable timeframe. This includes external and internal serious adverse events, protocol deviations, correspondence from sponsor, or any other documents requiring review and or submission to IRB. Additional non-regulatory reporting requirements would include submission of screening logs and database updates. For any protocol deviations that are known, these will be reported to Regulatory within 7 business days of knowing of the deviation. Baseline medical history, adverse events and concomitant medications are captured for all research subjects on multiple studies. Successfully applies the oncology Adverse Event term utilizing the NCI CTC. Adverse events tracking and concomitant medication tracking logs are maintained for research subjects on various studies. Participates in staff training on NCI CTC adverse event reporting. This training may include Adverse Events, Serious Adverse events, baseline medical history, and adverse event and concomitant medication tracking logs.
MUSC Minimum Training and Experience Requirements:
A bachelor’s degree and three years of relevant program experience.
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.
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