35% Assists Physician Investigators to identify, consent, screen, register/ enroll eligible patients to studies at Hollings Cancer Center and coordinates patient research related activities to accurately meet protocol requirements. Screens all patients at the Hollings Cancer Center that have been newly diagnosed, have progressed, or experienced a recurrence for possible inclusion into an active clinical trial. Informs potential patients on study specifics, coordinates initial protocol procedures/ treatment plan and ensures required follow up procedures. Ensure protocol compliance for study patients. Ensures database updates to reflect accurate patient status. Utilizes office tools including Sharepoint, Clinical Data Center (CDC) Inteliquet and CTMS. Attends and actively participates in regularly scheduled multidisciplinary tumor boards, clinics, conferences, and any other forum where patients may be discussed. Documents that all new patients to Hollings Cancer Center, including newly diagnosed patients and patients with progression or new disease are screened for trial eligibility. Ensures no ineligible patients are registered. Provides protocol specific information for physicians, primary nurses, and patients. Participates in informed consent process by explaining protocol specific information to the patient/family and facilitating consent document process. Coordinates the clinical work-up to determine patient eligibility. Coordinates treatment plan and required follow-up with patient, 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 patient 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 patient information into the clinical trials database. New patient enrollments and status updates are to be entered into the clinical trials database within 24 hours of the enrollment and or status change. This includes Screening, Screen Failures, Consenting, Enrolling, Active on Treatment, Follow up, Survival and Off study status. New patient enrollments and status updates are to be entered into 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 Patient Status changes and protocol-related patient visits be linked in EPIC prior to the protocol-related patient visit.
30% Timely and accurately collects and submits data to specified research bases. Ensures data quality and timely completion and submission of case report forms and queries by establishing effective daily routines and processes. Develops and implements an effective daily routine which minimally includes retrieval of ongoing data from local or outside source documents, completion of appropriate case report forms and any protocol-related 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 inpatient chart for case report form completion. Visit-specific CRFs are to be completed per sponsor requirements.
20% Timely and accurately submits Serious Adverse Events to sponsor, IRB and DSMC per 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 on-site Adverse Event reports and protocol deviation reporting as well as any new protocol documents which may include but are not limited to synopsis, confidentiality agreements, protocol, questionnaires, 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. For any protocol deviations that are known, these will be reported to Regulatory within 7 business days of knowing of the deviation. 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.
10% Participates in Trial Start up process for new studies. 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. As protocol amendments are received Amended Roadmaps are completed per assigned due 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. Obtains study specific credentialing as required per the protocol. Credentialing may include IMRT, IROC, TRIAD and study team training for specific study assessments. Communicates and documents any potential barriers for protocol activation. Provides timely responses to administrative and regulatory staff in regard to budget development, billing, and regulatory processing items.
5% Presents pertinent research related data to program leader 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 boards 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. Takes an active role in leading the program in trial selection and enrollment. Ensures all protocol information including priority diagrams are readily available, up to date and disseminated to all program members. Prepares and distributes meeting minutes.
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)