Medical University South Carolina

Job Description Summary

The Research Assistant will support clinical research activities within the Pediatric Research Group. This role will have direct patient interaction and work on minimal risk studies independently. Research Assistants help with and participate in the day-to-day operations related to the collection, compilation, and documentation of clinical research data. This role will support other PRG coordinators with interventional/drug studies under direct supervision.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type

Research Grant

Cost Center

CC001014 COM PEDS Clinical Research CC

Pay Rate Type

Hourly

Pay Grade

University-04

Pay Range

33,339.00 - 47,509.00 - 61,680.000

Scheduled Weekly Hours

40

Work Shift

Job Description

The Research Assistant will support clinical research activities within the Pediatric Research Group. This role will have direct patient interaction and work on minimal risk studies independently. Research Assistants help with and participate in the day-to-day operations related to the collection, compilation, and documentation of clinical research data. This role will support other PRG coordinators with interventional/drug studies under direct supervision.

The Research Assistant will:

• Collect, process, ship, and maintain inventory of research biological specimens
• Schedule study visits and assessments per protocol
• Maintain accurate and up-to-date paper and electronic regulatory documents
• Complete data entry in a timely manner including query resolution
• Help study recruitment efforts by completing pre-screening phone calls, reviewing medical charts, and speaking with subjects directly about enrolling studies during clinic visits
• Prepare lab kits for upcoming study visits, monitor the inventory of lab kits and study specific supplies and destroy expired lab kits as needed
• Provide support to other PRG coordinators during study visits as needed.This includes calling subjects to confirm appointments, filling documents, obtaining signatures from research staff in other MUSC locations, assisting with medical history and adverse event collection and documentation, and reviewing outside medical records
• Assist with study specific worksheet and source document creation

This position will be required to work on campus but may be eligible to work a hybrid work from home model after a probationary period. Position may also require weekend or after-hours work.

Research Operations (35%): Provides administrative support of recruitment strategies: prepares mailings, distributes flyers, phone marketing, etc. Provides administrative pre-screening support to study team, may maintain logs and data entry related to screening. Schedules participants for study visits. May also assist with the prepartion and gathering of study supplies, equipment, and documents as needed. Conducts visits for minimal risk studies independently. May also perform assessments for minmal risk studies or for greater than minimal risk studies under direct supervision. Collects data directly from participant or from the electronic medical record. Collects, prepares, ships, and/or maintains inventory of biological research specimens and processes and ships labs. Conducts and/or documents consent for participants in minimal risk studies. May conduct consent for studies greater than minimal risk under direct supervision. Files regulatory documents and reports. Creates a broad array of regulatory submissions (initial study applications) for minimal risk studies. Creates and submits simple regulatory reports (personnel amendments and continuing review applications) to the IRB. Prepares for study monitoring and study audit visits. May assist with addressing findings and resolving queries under supervision. Collects, prepares or processes adverse events under supervision. Administratively files external SAE reports or IRB SAE reports.

Data and Informatics (30%): Completes case report forms and enters data into EDC system(s). Resolves data queries. Creates and develops simple databases. Assists with the creation of simple data collection forms (surveys, CRFs, and/or source documents).

Communication (15%): Schedules and coordinates team meetings. Assists with preparing meeting documents.

Ethics and Participant Safety (5%): Understands the ethical conduct of research and safeguards needed when conducting human subjects research activities. Under supervision, adheres to management plans related to conflict of interest.

Site and Study Management (10%): Maintains study compliance with institutional requirements and other policies and maintains the Delegation of Authority Logs.

Other (5%): Administrative and other duties as assigned

Additional Job Description

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. 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