UNIV -Clinical Research Coordinator I - Medicine: Gastroenterology

UNIV -Clinical Research Coordinator I - Medicine: Gastroenterology Job no: 510420
Entity: MUSC University
Department: COLLEGE OF MEDICINE - COM-Dept of Medicine
Sub Department: UNIV-2220300-Gastroenterology
Work type: Full-Time
Employee Type: UNIV - Research Grant
Location: Charleston, SC-Main Campus
Categories: Clinical Trials, Research
Pay scale: UNIV-Band 5: $32,838.00 - $46,799.00 - $60,760.00 (min - mid - max)

Job Duties:20Responsible for the preparation, submission, maintenance and communication of all study documents with participating sites, regulatory committees including the IRB and sponsors. Duties include, but are not limited to, updating study documents, procedures, and Informed Consents; reporting adverse events and protocol deviations; processing continuing reviews and amendments.Essential20Serves as primary coordinator of related industry studies to include screening and enrollment of eligible subjects. Liaison with related study program manager(s) to assure synergy of research studies.Essential30Serves as liaison between MUSC and collaborating sites in regards to contracts, invoicing, training, tracking study progress and communicating activities to the PI and Program Manager. Provides oversight to site PIs to ensure compliance with regulatory Good Clinical Practice quality standards.Essential30Timely and accurate submission of data to specified research databases. Includes collecting data on protocol specific forms in addition to resolving queries.Essential

Job summary: This position is responsible for the coordination and facilitation of research activities of federally funded multisite studies including ancillary studies stemming from parent projects as well as new industry studies. The candidate will work closely with the Statistical and Data Coordination Center and up to 15 participating sites. The candidate will work with the Principal Investigator(s) (PIs) and related study coordinators for the development of study documents and critical communication pathways among essential personnel. Some travel may be required.

This position actively assists the PIs with human subject research in the coordination of complex study activities as directed by the PI. Responsibilities include the recruitment of study participants within study time tables, coordinating and scheduling study visits, data collection, conducting research assessments, and maintaining up-to-date regulatory files. This position requires exercising best practices in the patient management, providing timely and accurately reports from research databases to PIs and research staff, and provides support for the research investigators, faculty, trainee physicians, grants administrator, and program manager.

Payscale Salary Range: UNIV-Band 5: $32,838.00 - $46,799.00 - $60,760.00 (min - mid - max)

FLSA: To Be Determined

Minimum Experience and Training Requirements: A bachelor's degree and one year relevant program experience.

Preferred Experience, Knowledge, and Abilities: A bachelor's degree and two years’ relevant program experience. Candidate should have knowledge of research best practices to include regulatory documentation, research study logistics, and be able to work on several different projects in parallel. Must be able to work independently, detail-oriented, personable, and have excellent problem solving and analytical skills. Must meet physical requirements and standards of behavior as set forth by the Medical University of South Carolina, under the supervision of the Research Program Manager.

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)

Opening date: 29 Oct 2018 Eastern Daylight Time
Applications close:

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