Job Description Summary

Position is responsible for coordinating clinical trials in the Division of Cardiology. The Program Coordinator II will be responsible for working on IRB submissions independently, adhering to study guidelines, coordinating study visits, ensuring participants meet study inclusion/exclusion guidelines, provide education to patients and their families regarding study/study procedures. The Program Coordinator II will maintain study databases, abstract data and complete data entry into various data capture systems. Participant and regulatory binders will be kept up to date. The position will prepare for monitoring visits and serve as an expert resource when addressing and correcting findings.

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

Pay Range

$43,030 - $61,323 - $79,616

Scheduled Weekly Hours

40

Work Shift

Day (United States of America)

Job Description

Job Duties:

35% - Oversees day to day implementation of study activities. Screen participants independently and provides oversight and training to study team members who screen participants. Coordinate and schedule, as appropriate, various study visits, procedures and testing. Data abstraction and data entry/complete case report forms. Maintain and organize all study related documents. Maintain and update device accountability and/or drug accountability logs as needed. Provide participant reimbursement as appropriate. Oversees adverse event collection or provides expert guidance on identifying adverse events. Work with PIs to report AEs/SAEs and determine study relatedness/severity. Maintain screening logs, as applicable, enrollment logs, visit logs/schedules to ensure protocol adherence.

25% - Independently creates initial regulatory submissions, amendments, continuing reviews and reportable events. Communicates with the MUSC IRB as well as central IRBs to address any requests. Ensures studies are carried out according to Code of Federal Regulations, Good Clinical Practices, and MUSC policies. Obtain Informed Consent for study participation. Maintains all regulatory documents as required by protocol and standard policies and procedures. Communicates with sponsors and supplies necessary regulatory documents to sponsors, and/or CROs.

25%- Provides direction to study teams with preparation for study monitoring and study audit visits. Implements corrective action plans. Serves as an expert resource when addressing and correcting findings. Serves as a liaison between sponsors/CROs and site. Coordinates on site/remote study related activities such as site initiation visits, training, monitoring/auditing activities. Grants monitors EPIC access and releases study participants to monitors for visits. Follows up on any monitoring findings and provides any missing documents, completes/clarifies data discrepancies, addresses protocol adherence issues. Coordinates study updates between sponsors/CROs and site PI. Communicates with core labs as needed.

15%- Coordinate with other departments/units as needed for study related procedures/visits/testing. Provide other departments/units study specific protocols and/or training as appropriate. Complete billing review on a regular basis. Ensures study participants are associated with appropriate research study in EPIC. Places orders via order sets.

MUSC Minimum Training and Experience Requirements:

A bachelor's degree and two years 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 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