UNIV - Clinical Research Assistant - Advance - Department of Dermatology

Job Description Summary

The Clinical Research Assistant is responsible for coordination of sponsor-initiated studies for the Department of Dermatology. This person will also conduct all research in adherence with the FDA Code of Federal Regulations, "Good Clinical Practices”, and adhere to the MUSC IRB regulations for the protection of human subjects.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type​

Research Grant

Cost Center

CC000961 COM Dermatology CC

Pay Rate Type

Hourly

Pay Grade

University-04

Pay Range

32,686.00 - 46,578.50 - 60,471.000

Scheduled Weekly Hours

40

Work Shift

Job Description

The Clinical Research Assistant is responsible for coordination of sponsor-initiated studies for the Department of Dermatology. This person will also conduct all research in adherence with the FDA Code of Federal Regulations, "Good Clinical Practices”, and adhere to the MUSC IRB regulations for the protection of human subjects.

1.1 The Clinical Research Assistant will screen and prescreen potential patients for their assigned research studies. They will maintain screening and enrollment logs, as required, and provide periodic updates to the study team. 20%

1.2 The Clinical Research Assistant will ensure study-required clinical elements and tests are conducted and collected according to the protocol. They will conduct simple study visits per study protocol. 20%

1.3 The Clinical Research Assistant will obtain and document informed consent under the direction of the Principal Investigator. They will maintain accurate informed consent documents for later review. 10%

1.4 The Clinical Research Assistant will perform drug accountability for clinical trials that require investigational medications. 10%

1.5 The Clinical Research Assistant will assist Research Staff with lab sample preparation and documentation for all research protocols. 10%

1.6 The Clinical Research Assistant will complete case reports forms and other source documents in a timely manner. They will create simple data collection forms, when required, to capture protocol specific data. 10%

1.7 The Clinical Research Assistant will perform simple data entry to study databases in a timely manner. They will be responsible for the resolution of study specific queries within the EDC system. 10%

1.8 The Clinical Research Assistant will assist with regulatory tasks such as, document collection, and submitting, continuing review, amendments and reportable events to the Institutional Review Board. 10%

MUSC Minimum Training and Experience Requirements:

A high school diploma and four years of relevant program experience. A bachelor's degree may be substituted for the required program experience.

Preferred Requirements:

A bachelor's degree. Works independently with minimal supervision. Must exercise judgment and discretion. Establish and maintain effective working relationships. Must be able to communicate effectively.

Additional Job Description

Minimum Requirements: A high school diploma and four years of relevant program experience. A bachelor's degree may be substituted for the required program experience. 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. (Continuous) 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 lift objects, up to 15 lbs., from floor level to height of 36 inches, 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 hear and/or understand whispered conversations at a distance of 3 feet. (Frequent) Ability to perform gross motor functions with frequent fine motor movements. (Frequent) Ability to work in dusty areas. (Infrequent)

If you like working with energetic enthusiastic individuals, you will enjoy your career with us!

The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need.

Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees