UNIV -Research Data Coordinator - Hollings Cancer Center

Job Description Summary

This position coordinates protocol data management activities involving the National Cancer Institute (NCI), investigator initiated and industry sponsored oncology trials at the Medical University of South Carolina (MUSC).

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type​

Classified

Cost Center

CC001332 HCC CTO Administration

Pay Rate Type

Hourly

Pay Grade

University-04

Pay Range

33,339.00 - 47,509.00 - 61,680.000

Scheduled Weekly Hours

40

Work Shift

Job Description

Summary:

Under general supervision of the Clinical Trials Office (CTO) and specific disease group Program Manager within the Clinical Operations Unit, this position coordinates protocol data management activities involving the National Cancer Institute (NCI), investigator initiated and industry sponsored oncology trials at the Medical University of South Carolina (MUSC) including data entry into case report forms, specimen submissions, and patient follow-up visits.  Provides core support for oncology research studies at the Hollings Cancer Center. 

Responsibilities:

35% Maintains current, long-term follow-up and survival data on assigned patient caseload.   Data submission is timely and accurate per the protocol and patient calendar.    Patient management will include multiple disease programs and protocols.  Responsible for 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 Quality of Life surveys, radiologic scans, reports and staging tests.   Proactively plan, prioritize and manage responsibilities to ensure timely and accurate data submission to specified research bases.  Ensures data is submitted according to sponsor mandated time frames and in a manner that affords maximum accuracy.  Data submission will include query resolution, adverse event logs, and concomitant medication logs.  Ensures source documentation is present in-patient chart for source documentation verification.

25% Coordinates trial follow up patient visits and related activities to accurately meet protocol requirements. Provides protocol specific information for study coordinators, physicians, nurses, and study participants. Coordinates required follow-up requirements with patient, medical staff, nursing staff and ancillary hospital personnel. Ensures that follow-up assessments are completed per protocol to meet study requirements. Works closely with clinical nurse staff to coordinate patient care to meet protocol standards. Consults with the investigator to assess study participant for response to protocol therapy including toxicity assessment and disease status. Ensures timely clinical trial management system (CTMS) database updates to reflect accurate patient status within 24 hours. Links patient research visits in Epic prior to scheduled study visit date. Ensures source documentation is located within patient research chart for source documentation verification per departmental SOPs. 

20% Timely and accurately coordinates the process to request, prepare, ship and/or submit requirements per protocol and applicable study manuals. Submissions may include but are not limited to radiology images, EKGs, pathology specimens, blood borne pathogens and other biologic specimens.  Prepares, transports, and handles blood borne pathogens and other biologic specimens following OSHA and IATA guidelines.  Responsible for laboratory supply kit management including storage, inventory, and ordering to maintain lab kit supply. Lab kit management will require utilization of sponsor specific vendors along with internal lab kit and specimen management tracking systems and processes. Responsible for preparing kits for each study participant 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 Nexus SCTR services, Fast Flow and phlebotomy lab 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 study specific website including CTSU OPEN funding. Responsible for the transmitting of all required scans for the trials, addressing queries from the vendors, and working with MUSC radiology staff as needed to resolve any queries.   

10% Process protocols and patient related documents and data forms. Compiles lists, maintains patient/study calendars, and creates and maintains necessary documents.  Resolves sponsor queries correctly, completely and in a timely fashion. Process request for pathology slides and shipping slides to sponsor.   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. 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. 

10% - Attends and actively participates in staff training and education regarding data management and clinical operations processes. Trainings include but are not limited to CTO staff meetings, Clinical Operations Update Meetings, huddles and team meetings. Works effectively and cooperatively with colleagues to assist routine monitor visits. Utilizes office tools including sharepoint, clinical trial management system, Clinical Data Center (CDC), and other applicable platforms. Collaborates with Study Coordinators as needed with participant protocol visits including participant questionnaires, escorting study participants to various locations on campus, picking up IDS oral study medication, and transporting study supplies. Completes other research tasks and projects as assigned.  Staff training may include CTSU, NCI data bases, CTMS, SharePoint, EPIC EMR, EPIC patient linking of research participants, collection and shipping of specimens, requesting internal and external radiologic images and submitting to study sponsor. 

Additional Job Description

Minimum Requirements: A high school diploma and three years of relevant program experience. A bachelor's degree may be substituted for the required 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. (Continuous) 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 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 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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