MUSC Health · 1 week ago
UNIV- Research Study Coordinator - Hollings Cancer Center
Charleston, SC
Full-time
Onsite
Entry, Mid Level
$40K/yr - $57K/yr
2+ years expMedical University of South Carolina (MUSC) is seeking a Research Study Coordinator to join their Clinical Trials Office. The role involves coordinating and supervising complex research protocols at the Hollings Cancer Center, ensuring compliance and promoting awareness of clinical trials among potential participants.
Health CareHospitalMedical
Responsibilities
Coordinates patient research related activities to accurately meet protocol requirements
Ensure protocol compliance for study participants
Ensures database updates to reflect accurate patient status
Utilizes office tools including Sharepoint, Clinical Data Center (CDC), and clinical trial management system (CTMS)
Provides protocol specific information to physicians, primary nurses, and patients
Coordinates the clinical work-up to determine patient eligibility
Coordinates treatment plan and required follow-up with study participant, medical staff, nursing staff and ancillary hospital personnel
Ensures that follow-up requirements per protocol are carried out in order to assess for response to treatment
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
Coordinates and conducts activities associated with the preparation and shipment of protocol related samples within specified parameters
Prepares, transports, and handles bloodborne pathogens and other human specimens following OSHA guidelines
Enters and maintains both current and new study participant information into the clinical trials database
New patient enrollments and status updates are to be entered into the CTMS within 24 hours of the enrollment or status change
This includes Screening, Screen Failures, Consenting, Enrolling, Active on Treatment, Follow up, and Off study status
New patient enrollments and status updates are to be entered/confirmed in EPIC within 24 hours of the enrollment and or status change
This includes Consented- in screening, Enrolled-Receiving treatment and/or intervention, Enrolled-follow up only, lost to follow up, Screen failure and completed
Research participant protocol-related visits must be linked in EPIC prior to the encounter
Assists investigators to identify, consent, screen, register/ enroll eligible patients to studies at Hollings Cancer Center
Screens all patients at the Hollings Cancer Center (HCC) that have been newly diagnosed, have progressed, or experienced a recurrence to potentially be included into a clinical trial
Attends and actively participates in regularly scheduled multidisciplinary tumor boards, clinics, conferences, and any other forum where patients may be discussed
Documents and tracks all screening efforts per departmental guidelines
Establishes communication with physician investigators and care team regarding potential study participants
Effective screening of HCC patient medical records requires knowledge of oncology terminology, medical terminology, disease specific staging and each clinical trial protocol eligibility criterion
Meets weekly with their clinical operations team to discuss potential trial participants and plan for the upcoming week for all clinic coverage needs
Under guidance of the team lead coordinator(s) and program manager, will support research activities at any of the MUSC main campus and HCC satellite locations and make necessary coverage plans in advance, to avoid interruption of quality CTO services
Participates in and supports the informed consent process per departmental and institutional policy
Timely and accurately collects and submits data to established research bases including the National Cancer Institute, industry sponsors and MUSC
Ensures data quality and timely completion and submission of case report forms (CRFs) and queries
Develops and implements an effective daily routine which minimally includes retrieval of ongoing data from local or outside medical records, completion of appropriate case report forms and any data query received
Ensures data is submitted according to sponsor mandated time frames and in a manner that affords maximum accuracy
Ensures source documentation is present in-patient chart for case report form completion
Visit-specific CRFs are to be completed per sponsor requirements
Case report submission may include patient reported outcome questionnaires, 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
Collaborates with Data Coordinators as needed with patient protocol visits including adverse event logs, patient questionnaires, picking up specimens, and transporting study supplies
Maintains established workflows to identify data needs of numerous trials within multiple disease groups and communicates data entry needs to study team
Timely and accurately submits Adverse Events, Serious Adverse Events, and other reportable events to the NCI, sponsors, IRB and DSMC per federal guidelines and institutional policies
Prepares and submits CTO-required and sponsor specific initial and follow up reports
Adheres to the reporting requirements within the Clinical Trials Office, MUSC and various study sponsors
Proactively plans to ensure reports are comprehensive and that reporting requirements are met within the allowable timeframe and in a manner that affords maximum accuracy
Submits regulatory documents upon receipt to the Manager of Regulatory Compliance to ensure timely reporting by the regulatory unit of CTO
This includes Adverse Event reports and protocol deviation reporting as well as any new protocol documents which may include but are not limited to protocol amendments, 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
Protocol deviations will be reported to the clinical trials office regulatory unit per departmental processes
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
Maintain working knowledge of disease specific trial portfolio and participate in disease focus group meetings to support trial start up process for new studies and maintenance of protocol amendments
Presents pertinent research related data to the research focus group and individual investigators
Maintains up to date protocol information, communication and education of study and clinic personnel
Assists in planning, implementing, and evaluation of program expansion and new projects
Positively and professionally contributes to working groups and meetings
Initiates and organizes meetings and prepares meeting agendas
Discusses high priority trials
Presents protocols to programs and clearly assesses patient population and feasibility of trial
During the 'In Approval Process-Step 1' reviews new protocols, completes the initial roadmap submission by designated timeline and obtains study specific credentialing per protocol requirements
Collaborates with the CTO nurse managers in development of initial roadmap and amended roadmaps as applicable
As protocol amendments are received amended roadmaps are completed by the assigned date to ensure patient safety
Completes the Initial roadmap submission by assigned due date
Roadmap submission forms are comprehensive and include all study assessments required per the protocol and study calendar
Roadmap submission forms are accurate including treatment arms, hold and call parameters and dosing modifications per the protocol guidelines
Qualification
Required
A bachelor's degree and two years of relevant program experience
Company
MUSC Health
MUSC Health provides health-care services through its patient- and family-centered care, education, research, and various partnerships. It is a sub-organization of Medical University of South Carolina.
Founded in 1824Charleston, South Carolina, USA
10001+ employees
Funding
Current Stage
Late StageTotal Funding
$133MKey Investors
Armadale Capital
2019-12-19Debt Financing· $133M
Leadership Team
Erik Summers
Chief Medical Officer
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