UNIV - Research Program Assistant - Advance - Department of Dermatology

Job Description Summary

The Clinical Research Program Assistant provides administrative, regulatory, and operational support for clinical research studies conducted within the department. This position assists investigators and research staff with participant recruitment, scheduling, data management, regulatory documentation, and study coordination activities while ensuring compliance with institutional, sponsor, IRB, and federal requirements. Responsibilities are performed under the guidance of Clinical Research Coordinators, Program Managers, and Principal Investigators.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type​

Research Grant

Cost Center

CC000961 COM Dermatology 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

Job Description

Job Duties:

• Study Coordination and Participant Support (35%)
  • Assist with participant recruitment and retention activities.
  • Schedule study visits and coordinate participant appointments.
  • Contact participants regarding upcoming visits and study-related activities.
  • Prepare study materials and participant packets.
  • Support informed consent visits as directed by study staff.
  • Facilitate communication between participants and the research team.
• Regulatory and Administrative Support (25%)
  • Maintain regulatory binders and study files.
  • Assist with preparation of IRB submissions, amendments, continuing reviews, and study correspondence.
  • Organize and maintain essential study documents.
  • Track study training requirements and certifications.
  • Support sponsor monitoring visits and audits through document preparation and organization.
• Data Management and Documentation (20%)
  • Enter study data into electronic databases and study management systems.
  • Maintain source documentation and screening logs.
  • Review records for completeness and accuracy.
  • Assist with query resolution and data collection activities.
  • Generate study reports as requested by research staff.
• Research Operations Support (15%)
  • Assist with preparation of study supplies and materials.
  • Coordinate shipment and receipt of research materials and laboratory specimens.
  • Support study start-up and close-out activities.
  • Maintain inventory of study-related equipment and supplies.
  • Assist with preparation for sponsor and institutional audits.
• Other Duties (5%)
  • Participate in departmental meetings and training programs.
  • Complete required institutional training.
  • Perform other duties as assigned to support departmental research operations.

Minimum Qualifications Preferred:

• Bachelor's degree in a health science, biological science, public health, psychology, or related field preferred.
• One year of administrative, healthcare, research, or customer service experience preferred.
• Strong organizational and communication skills. Proficiency with Microsoft Office applications.
• Ability to maintain confidentiality and comply with HIPAA requirements.
• Ability to manage multiple priorities in a fast-paced environment.

Knowledge, Skills, and Abilities Preferred:

• Understanding of clinical research principles and Good Clinical Practice (GCP).
• Ability to follow detailed protocols and instructions. Strong attention to detail and documentation accuracy.
• Excellent interpersonal and customer service skills.
• Ability to work independently and as part of a multidisciplinary team.
• Ability to learn clinical research management systems such as OnCore and REDCap

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: (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. (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)

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