UNIV-Research Study Coordinator - Hollings Cancer Center

Medical University of South Carolina•Charleston, SC

11d•Onsite

About The Position

Under general supervision of the Clinical Trials Office (CTO), Manager of Clinical Operations, this role coordinates, establishes, and supervises complex research protocols at the Hollings Cancer Center (HCC) to efficiently and effectively integrate cooperative group and industry sponsored trials at the Medical University of South Carolina (MUSC). This position actively promotes and increases awareness of the clinical trial program within HCC, exercises judgment regarding proper patient management, and ensures timely and accurate reporting to research bases, the National Cancer Institute, and MUSC staff.

Requirements

A bachelor's degree
Two years of relevant program experience
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 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 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)

Nice To Haves

Knowledge of oncology terminology, medical terminology, disease specific staging and each clinical trial protocol eligibility criterion is required for effective screening of HCC patient medical records.

Responsibilities

Coordinates patient research related activities to accurately meet protocol requirements, ensuring protocol compliance for study participants and 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 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, with new patient enrollments and status updates entered into the CTMS within 24 hours.
Enters/confirms new patient enrollments and status updates in EPIC within 24 hours.
Links research participant protocol-related visits 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 for possible inclusion 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.
Meets weekly with their clinical operations team to discuss potential trial participants and plan for the upcoming week for all clinic coverage needs.
Supports research activities at any of the MUSC main campus and HCC satellite locations and makes necessary coverage plans in advance.
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 plans, prioritizes and manages responsibilities to ensure timely and accurate data submission to specified research bases.
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.
Addresses and closes outstanding items per sponsor monitoring visit letters within 4 weeks of receiving the monitoring letter, or by the date of the monitor’s next site visit, whichever is earlier.
Maintains working knowledge of disease specific trial portfolio and participates 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.
Reviews new protocols during the “In Approval Process-Step 1”, 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.
Completes amended roadmaps as protocol amendments are received to ensure patient safety.
Completes the Initial roadmap submission by assigned due date.
Ensures roadmap submission forms are comprehensive and include all study assessments required per the protocol and study calendar.
Ensures roadmap submission forms are accurate including treatment arms, hold and call parameters and dosing modifications per the protocol guidelines.