UNIV - Research Program Assistant - Surgery: Clinical Trials

C001 Medical University of South Carolina (MUSC - Univ); South Carolina; On-site; USD 38,000 - 61,000; Full time

Job summary

The Clinical Research Assistant at MUSC supports investigator-initiated transplant studies in the Department of Surgery, coordinating study activities, visits, and data collection per FDA CFR, Good Clinical Practice, and MUSC IRB regulations.

Responsibilities include obtaining informed consent, maintaining logs, screening patients, and accurate data entry in study databases. A high school diploma with four years of relevant experience is required; a bachelor's degree may substitute.

Qualifications

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

Responsibilities

• Coordinate study-required clinical elements and tests per protocol.
• Obtain and document informed consent under PI direction.
• Screen and prescreen potential patients and maintain logs.
• Complete case report forms and data collection forms as required.
• Perform data entry and resolve study queries in the EDC system.

Skills

Study coordination

Informed consent

Data entry

Education

High school diploma

Bachelor's degree substituted

Tools

IRB documentation

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 Scheduled Weekly Hours 40 Work Shift

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

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:

• 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)

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.

Thank you for wanting to be part of the Medical University of South Carolina team. Whether you want to teach the next generation of health care leaders, innovate new business models, discover the next breakthrough or provide patient care, there's a role for you that fuels your passion and takes advantage of your skills. There are career opportunities available in academics, research, hospital medicine, physician practices and support services, from patient billing to IT. As an applicant, you can search jobs for all MUSC entities as well as search by category and location. MUSC attracts more than $250 million annually in research funding, making it the biggest magnet for biomedical, extramural research dollars of all institutions of higher learning in South Carolina. The Clinical and Translational Science Award (CTSA) Program aims to advance clinical and translational science to increase the speed at which new treatments become available to patients. MUSC Health, the clinical enterprise, operates a 750 bed medical center, which includes a nationally recognized Children’s Hospital, the Ashley River Tower (cardiovascular, digestive disease, and surgical oncology), Hollings Cancer Center (one of fewer than 70 elite National Cancer Institute designated centers), a Level I Trauma Center and the Institute of Psychiatry. In addition, there are more than 100 outreach clinics, hospital/health system affiliations, and telehealth sites. U.S. News & World Report placed us among the top one percent of all American hospitals, with 11 specialties in the top 50. The MUSC Medical Center is also one of only three Magnet designated hospitals in South Carolina.