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.
Entity
Medical University of South Carolina (MUSC - Univ)
Worker Type
Employee
Worker Sub-Type
Research Grant
Cost Center
CC000966 COM DOM CARD General CC
Pay Rate Type
Salary
Pay Grade
University-06
Pay Range
46,655.00 - 66,488.00 - 86,321.000
Scheduled Weekly Hours
40
Work Shift
Job Description
Job Duties:
35% - Maintain up-to-date knowledge of all assigned research projects. Review, evaluate and report to PI and Research Manager on a monthly basis, as to study status. Perform research activities: subject recruitment, consent, and research visits according to study protocol. Collaborate with all members of the research team in developing and implementing strategies for effective management of research studies.
25% - Coordinate/perform the reporting and communications with the IRB and the study sponsor as relevant to research protocols, study implementation, adverse events, ongoing study updates, and other activities necessary for exceptional performance from study activation to closeout. Assist PI in completing initial IRB submission and all Amendments as necessary.
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% - Independently manage study-specific data and identify data discrepancies.
5% - Serves as mentor/preceptor for new hires within Cardiology Clinical Trials
Preferred Experience, Knowledge and Skills: 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, CCRT 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.
Additional Job Description
Minimum Requirements: A bachelor's degree and two years of relevant 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. (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)
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
