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Medical University of South Carolina UNIV - Research Specialist II - Neurology in Charleston, South Carolina

FLSA: Hourly

Job Summary: The Research Specialist II will report to the Neurology Department and assists principal investigators, research staff and trainees on research techniques and procedures. Under the direction of the Murray Center Director, the incumbent will develop new research projects according to concepts provided by principal investigators. Teaches and participates in complex laboratory research. Plans and organizes research and evaluation of scientific literature. Uses manual and computer techniques to analyze research data. Individual will be responsible for conducting and overseeing all research related activities within assigned clinical trials to include the coordination of study visits, all regulatory aspects, management of study documents and promotion of study integrity/protocol compliance

Payscale Salary Range: UNIV-Band 5: $33,494.00 - $47,734.00 - $61,975.00 (min - mid - max)

Job Duties:

  • 35% - Coordinates all phases of clinical trials regulatory management for Movement Disorders studies: (i.e. study start-up/initial submission, interim maintenance, annual renewals, amendment processing and closeout activities.) Prepares all levels of regulatory documents for study implementation, ongoing maintenance and amendments to include sponsor required documents, as well as local IRB documentation. Prepares and finalizes required Sponsor and Departmental (Movement Disorders) regulatory/compliance reports. - (Essential)

  • 25% - Recruits study participants per study inclusion and exclusion criteria to meet study contract enrollment. Schedules study participants, caregivers, and research personnel for study visits in compliance with study protocol. Coordinates with research physicians, raters, and other study staff for timely completion of all study activities, and ensures all resource areas are available for completion of study visits. Records all financial activities of study for billing study sponsors, and paying subcontractors and vendors. Complies with all university and departmental policies and procedures as well as Federal, State, and Food and Drug Administration regulations. - (Essential)

  • 20% - Transcribes data into case report forms completely and accurately. Monitors completeness and accuracy of case report forms, and coordinates collection and filing of all source documents. Performs data entry as per study protocol. - (Essential)

  • 10% - Performs rating scales for human subjects as required by study protocol. Performs safety assessments to include vital signs, electrocardiograms, blood draws and lab processing. Dispenses study medications, and verifies drug compliance per study protocol. - (Essential)

  • 10% - Coordinates monitoring visits, and completes corrections and queries in a timely manner. Assists other study teams as needed to meet study requirements and organizational goals. - (Essential)

Preferred Experience & Additional Skills: A bachelor's degree in chemistry, biology, or other natural, life or health care science directly related to the assigned area of research and two years advanced journey-level work experience in a clinical or research setting.

Minimum Experience and Training Requirements: A bachelor's degree in chemistry, biology, or other natural, life or health care science and one year work experience directly related to the assigned research area.

Physical Requirements: Ability to perform job functions in an upright position. (Frequent) Ability to perform job functions in a seated position. (Continuous) Ability to perform job functions while walking/mobile. (Frequent) Ability to climb, using step stool. (Infrequent) Ability to work in temperature extremes (32? F to 100? F) when required due to assignments in cold rooms and/or foreign countries. (Infrequent) Ability to work in confined/cramped spaces. (Continuous) Ability to bend at the waist. (Frequent) Ability to twist at the waist. (Frequent) Ability to fully use both hands/arms. (Continuous) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to fully use both legs. (Frequent) Ability to reach in all directions, stretch, bend, while moving items/materials from both sitting and standing positions. (Frequent) Ability to maintain good olfactory sensory function/distinction. (Continuous) Ability to lift materials up to 20 lbs., unassisted. (Infrequent) Ability to lift and carry 4 liter waste material bottles a distance of 30 feet, unassisted. (Frequent) Ability to lift and carry 25-30 lbs. jugs of liquid a distance of 100 feet, unassisted. (Infrequent) Ability to lift file boxes, from floor level to counter tops, unassisted. (Frequent) Ability to push/ Ability to lift 40 lbs. centrifuge rotors from floor level to height of 40 inches, then down 20 inches into centrifuge drum, unassisted. (Infrequent) Ability to lift 25 lbs. boxes, from floor level to maximum height of 72 inches, unassisted. (Infrequent) Ability to push/pull file boxes from one location to another at floor level. (Frequent) Ability to maneuver heavy equipment on bench tops, 50 lbs. or greater, unassisted. (Frequent) Ability to perform gross motor functions with frequent fine motor movements. (Continuous) Ability to maintain 20/20 vision, corrected. (Continuous) Ability to match or discriminate between colors, normally. (Continuous) Ability to hear and recognize various alarms emitting from work area systems. (Continuous) Ability to hear and/or understand conversations. (Continuous) Ability to work in a darkroom for processing film, etc. (Continuous) Ability to be qualified physically for respirator use, initially and annually. (Continuous)