Job Description Summary

This individual will be responsible for ensuring adherence to study guidelines, coordinating study visits, ensuring participants meet stringent clinical inclusion guidelines and providing education to patients and their families. The candidate will be responsible for all regulatory aspects of multiple studies, maintaining study databases, completing study documents, recruiting study patients, communicating with Principal Investigators and sponsors as well as preparing and conducting audits. The position requires excellent communication and research skills. Must have strong computer skills (EPIC, Word, Excel, database software, web-based activities, email). Knowledge of MUSC IRB policies and procedures is necessary. Required certifications include CITI certifications in Biomedical Research and Good Clinical Practice, CCRP certification, and shipping hazardous materials. Experience coordinating clinical trials that involve drugs, devices, and procedures is necessary. This position requires excellent time management, and the ability to work independently. A willingness to work flexible hours is necessary; some weekend and evening work may be required.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type​

Research Grant

Cost Center

CC000966 COM DOM Cardiology CC

Pay Rate Type

Salary

Pay Grade

University-06

Scheduled Weekly Hours

40

Work Shift

Day (United States of America)

Job Description

Job Duties:

35% - Maintain up-to-date knowledge of the study. Review, evaluate and report to PI and Nurse Administrator on a monthly basis, as to study status. Perform research activities: subject recruitment, consent, and research visits according to study protocol. Assist with preparation for Data Safety Monitoring Board meetings. Collaborate with all members of the research team in developing and implementing strategies for effective management of research study.

25% - Coordinate/Perform the reporting and communications with the IRB and the study sponsor as relevant to research protocols, study implementation, adverse events (AEs), ongoing study updates, and other activities necessary for exceptional performance from study activation to close-out.

20% - Independently Schedules complex, multi-step study procedures; Coordinates with multiple departments, physicians, and sponsor for research procedures; Participates in feasibility and logistical planning for new and ongoing studies.

15% - ICF writing and IRB study maintenance; Collaborate with MUSC PIs in protocol writing and study design for investigator initiated studies; RedCap database build and design as necessary for investigator initiated studies.

5% - Participate in MUSC IRB, VA R&D, and /or Sponsor initiated audits; Independently Manage Study-specific Data an Identify Data Discrepancies, and Develop Corrective Action Plans; Participate in FDA Study inquiry including query response and corrective action plan development.

MUSC Minimum Training and Experience Requirements:

A bachelor's degree and two years of relevant program experience.

MUSC 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. (Frequent)
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 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 perform gross motor functions with frequent fine motor movements. (Frequent)

Additional Job Description

A bachelor's degree and two years of relevant program experience.

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