Medical University of South Carolina UNIV - Study Coordinator - Hollings Cancer Center in Charleston, South Carolina
Job Summary: Under general supervision of the Clinical Trials Office (CTO), Manager of Clinical Operations, 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). Actively promotes and increases awareness of the clinical trial program within HCC, exercises judgment regarding proper patient management, timely and accurately meets established reporting systems to research bases, National Cancer Institute, and MUSC staff.
35% - 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) and Rapid. Completes other tasks and projects as assigned. - (Essential)
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 - (Essential)
15% - 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 - (Essential)
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. - (Essential)
5% - Attends and actively participates in Disease Specific Focus Group Meetings. 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 - (Essential)
5% - Participates in education of MUSC personnel regarding clinical trials. Assists in orientation of new staff as directed. Serves as liaison and resource to community, hospital, physicians, and associated staff. Assists in coverage of other research activities - (Essential)
Minimum Experience and Training Requirements : A bachelor's degree and one year relevant program experience.
Physical Requirements: 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 20/20 vision, corrected. (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)