MUSC Health & Medical University of SC
UNIV - Research Data Coordinator - Hollings Cancer Center
MUSC Health & Medical University of SC, Charleston, South Carolina, United States, 29408
Job Description SummaryUnder general supervision of the Clinical Trials Office (CTO) and specific disease group Program Manager within the Clinical Operations Unit, this position coordinates complex data management activities involving NCI Cooperative group, Investigator Initiated and industry sponsored oncology trials at the Medical University of South Carolina (MUSC). Provides core support for protocol management, patient and data management for oncology research studies conducted at the Hollings Cancer Center. Professional judgment is required regarding patient management and research protocol compliance.
EntityMedical University of South Carolina (MUSC - Univ)
Worker TypeEmployee
Worker Sub-TypeClassified
Cost CenterCC001332 HCC CTO Administration
Pay Rate TypeHourly
Pay GradeUniversity-05
Pay Range$37,860 - $53,957 - $70,054
Scheduled Weekly Hours40
Work Shift
Job Description
Job Responsibilies
35% - 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 in order 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.
35% - 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. 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.
15% - 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.
15% 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. Utilizes office tools including SharePoint, CTMS, Clinical Data Center (CDC), Inteliquet and multiple platforms. Enters and maintains patient status information in CTMS clinical trials database. Ensures timely CTMS Database updates to reflect accurate patient status and links patient visits in EPIC. Supports the Study Coordinator as needed with patient protocol visits including QOL surveys, escorting patients to various locations on campus and picking up IDS oral study medication. Completes other research tasks and projects as assigned. Documents are uploaded to SharePoint and platforms in a timely manner as required. Items that are outstanding per sponsor monitoring visit letters will be addressed and closed within 4 weeks of receiving the monitoring letter, or by the date of the monitor's next site visit, whichever is earlier. Exhibits a cooperative attitude by projecting a positive attitude, displaying courtesy to others and by demonstrating an eagerness to help. Works effectively and cooperatively with others in achieving organizational goals; maintains harmonious working relationships with fellow employees. Consistently behaves in professional manner within the Cancer Center, clinical trials office and MUSC. Assists with the development of educational materials specific to each study and disseminates to appropriate staff. Staff training may include CTSU, NCI data bases, CTMS, SharePoint, EPIC EMR, EPIC patient linking of research subjects, collection and shipping of specimens and radiologic images to study sponsor. Linking Patient Research visits in EPIC prior to scheduled visits and updating Patient Status in CTMS and EPIC within 24 hours.
MUSC Minimum Training and Experience Requirements:
A bachelor's degree and two 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 DescriptionMinimum Requirements: A bachelor's degree and two 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
EntityMedical University of South Carolina (MUSC - Univ)
Worker TypeEmployee
Worker Sub-TypeClassified
Cost CenterCC001332 HCC CTO Administration
Pay Rate TypeHourly
Pay GradeUniversity-05
Pay Range$37,860 - $53,957 - $70,054
Scheduled Weekly Hours40
Work Shift
Job Description
Job Responsibilies
35% - 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 in order 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.
35% - 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. 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.
15% - 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.
15% 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. Utilizes office tools including SharePoint, CTMS, Clinical Data Center (CDC), Inteliquet and multiple platforms. Enters and maintains patient status information in CTMS clinical trials database. Ensures timely CTMS Database updates to reflect accurate patient status and links patient visits in EPIC. Supports the Study Coordinator as needed with patient protocol visits including QOL surveys, escorting patients to various locations on campus and picking up IDS oral study medication. Completes other research tasks and projects as assigned. Documents are uploaded to SharePoint and platforms in a timely manner as required. Items that are outstanding per sponsor monitoring visit letters will be addressed and closed within 4 weeks of receiving the monitoring letter, or by the date of the monitor's next site visit, whichever is earlier. Exhibits a cooperative attitude by projecting a positive attitude, displaying courtesy to others and by demonstrating an eagerness to help. Works effectively and cooperatively with others in achieving organizational goals; maintains harmonious working relationships with fellow employees. Consistently behaves in professional manner within the Cancer Center, clinical trials office and MUSC. Assists with the development of educational materials specific to each study and disseminates to appropriate staff. Staff training may include CTSU, NCI data bases, CTMS, SharePoint, EPIC EMR, EPIC patient linking of research subjects, collection and shipping of specimens and radiologic images to study sponsor. Linking Patient Research visits in EPIC prior to scheduled visits and updating Patient Status in CTMS and EPIC within 24 hours.
MUSC Minimum Training and Experience Requirements:
A bachelor's degree and two 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 DescriptionMinimum Requirements: A bachelor's degree and two 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