UNIV - Research Program Assistant - Surgery: Clinical Trials

experiencedAlliedHealth; Charleston (SC); On-site; USD 38,000 - 61,000; Full time

Job summary

Medical University of South Carolina (MUSC) is seeking a Clinical Research Assistant to coordinate investigator-initiated transplant studies for the Department of Surgery, ensuring adherence to FDA CFR, Good Clinical Practices, and MUSC IRB regulations protecting human subjects.

The role includes conducting study visits, obtaining informed consent, screening patients, completing case report forms, data entry into study databases, and maintaining accurate documentation within a 40-hour work week.

Qualifications

• High school diploma and at least four years of relevant program experience (bachelor’s degree may substitute).
• Experience coordinating investigator-initiated studies is a plus.
• Familiarity with FDA CFR, GCP, and IRB regulations is preferred.

Responsibilities

• Coordinate transplant study activities per protocol.
• Obtain and document informed consent.
• Screen and prescreen potential participants for studies.
• Complete case report forms and other source documents on time.
• Enter data into study databases and resolve queries in the EDC system.

Skills

Clinical research coordination

Informed consent

Data entry

Education

High school diploma + 4 years relevant program experience

Bachelor’s degree may substitute required experience

Job description

Job Description Summary

The Clinical Research Assistant is responsible for coordination of investigator-initiated transplant studies for the Department of Surgery as directed by the Principal Investigator. 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

CC001076 COM Urology CC

Pay Rate Type

Hourly

Pay Grade

University-GEN06

Pay Range

37,944.00 - 49,266.00 - 60,690.000

Pay Range

$37,944.00 - $49,266.00 - $60,690.00 (min - mid - max)

Scheduled Weekly Hours

40

Job Duties

• 35% - The Program 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.
• 25% - The Program Assistant will obtain and document informed consent under the direction of the Principal Investigator. They will maintain accurate informed consent documents for later review.
• 20% - The Program 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.
• 10% - The Program 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% - The Program 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.

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