UNIV - Clinical Research Assistant; Regulatory; Department of Medicine: Division of Pulmonary

Job Description Summary

This Clinical Research Assistant will work with the program’s regulatory team to provide program support for regulatory processes. They will communicate as needed investigator, IRB, and study sponsors to keep program studies in good standing.

Medical University of South Carolina (MUSC - Univ)

Employee

Research Grant

CC000974 COM DOM PULM General CC

Hourly

University-GEN
06

37,944.

- 60,690.000

40

• 35% - Responsible for meticulous and careful management of regulatory documentation of the Program’s regulatory files; maintains up-to-date files of CVs, medical licensure, note-to-files, conflict of interests, training documentation, laboratory certifications and other documents as needed. Ensures regulatory documents are updated in a timely manner and available for the site monitor at all times.
• 35% - Build electronic regulatory binders. Alert staff of new documents that are available and ensure documents are filed. Route and track completion of documents requiring signature. Will be responsible for preparing regulatory files for on-site monitoring visits, sponsor audits and regulatory authority audits, as well as reconciling and resolving action items following said on-site visits.
• 15% - Assist with the following as needed: scheduling and setting up monitoring visits and access for monitors; complete annual continuing reviews on all open studies.
• 10% - Perform other duties as required. Assist with Source Database building in Redcap.
• 5% - Provide general office support as needed.

Minimum Requirements:

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

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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…