UNIV - Research Program Coordinator I - Advance - Department of Regenerative Medicine

Job Description Summary

The laboratory of Dr. Russell Norris in the Department of Regenerative Medicine is seeking a Program Coordinator who will be responsible for coordinating clinical research activities across multiple clinical and research disciplines at MUSC, including the Ehlers-Danlos Syndrome Institute and departments of Dermatology, Gastroenterology, Neurosurgery, Orthopedics, and Regenerative Medicine. The coordinator will oversee all aspects of these research projects, and act as primary liaison between the Principal Investigator (Norris), School of Medicine, research administration, GCRC, funding agencies, and other study related organizations. We are looking for someone with excellent interpersonal and communication skills, the ability to manage multiple projects simultaneously, strong organizational skills and attention to detail, and a desire to collaborate as part of a fast-paced, dynamic research environment.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type

Research Grant

Cost Center

CC001062 COM REG MED Operations CC

Pay Rate Type

Hourly

Pay Grade

University-05

Pay Range

38,985.00 - 55,559.50 - 72,134.000

Scheduled Weekly Hours

40

Work Shift

Job Description

Job Duties:

Project Management (30%)

• Assist the principal investigators with multiple clinical research projects.
• Manage daily operations of research protocols, ensuring all study requirements are met. Responsible for monitoring the clinical course and collection of research data on patients entered into research protocols.
• Write and submit Institutional Review Board (IRB) protocols, amendments, annual renewals, and safety reports.
• Ensure compliance with all IRB regulations and maintain documentation of adverse events and protocol deviations. Maintain regulatory binders per protocols
• Assist with preparation for and participation in audits by regulatory agencies.
• Ensure study personnel are up to date on training requirements
• Establish study calendar of various clinical protocols and coordinate the logistics needed for successful and timely completion of the studies.
• Manage study finances, keeping detailed records of study expenditures and collaborate with budget analysts for accurate financial reporting. Utilize prospective reimbursement analysis for billing and ensure prompt reimbursement processing.

Administrative Liaison (25%)

• Act as the primary contact for internal research staff and operational liaison with various departments.
• Meet regularly with Principal Investigators to review data and overall study progress
• Coordinate with Division Chiefs, Center Directors, and departmental leadership to address challenges, ensure data accuracy, and maintain compliance.
• Design and compile materials which aid physicians and other staff in complying with protocol requirements.
• Prepare for, conduct, and participate in internal and external audits of studies

Patient Care Coordination (25%)

• Supervise patient care activities in research studies, including recruitment, screening, and enrollment.
• Verify patient eligibility for clinical studies and assist clinicians with informed consent processes.
• Act as the primary contact for study participants, scheduling appointments, confirming visits, and guiding patients to locations.
• Schedule and facilitate research visits to ensure compliance with protocol timelines.
• Maintain research database of patients enrolled in clinical studies.
• Facilitate on site bio-specimen collection in clinic, lab, operating room, and/or other locations as required by protocol.

Data Management (10%)

• Create standard operating procedures for clinical and basic science research, including biospecimen processing and storage.
• Oversee the collection, organization, and entry of clinical research data, ensuring strict accuracy and compliance with protocols.
• Maintain online Clinical Research Management Systems.
• Perform quality checks on data. Oversee the completion of work with members of the research team regarding data management.
• Abstract patient clinical and demographic information from various sources for database entry. Assist with preparation of data for reports and presentations. Promptly address queries related to data or special projects from PI or collaborators.

Sponsor Coordination (10%)

• Act as a liaison with study sponsors, coordinating monitoring visits, audits, and sponsor communications.
• Prepare materials and documentation for sponsor engagement and maintain consistent communication.
• Assist with study reports

Additional Job Description

Minimum Requirements: A bachelor's degree and three 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