UNIV - Research Program Assistant - Advance - Department of Dermatology

Medical University of South Carolina•Charleston, SC

2d•Onsite

About The Position

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.

Requirements

A high school diploma and four years of relevant program experience.
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.

Nice To Haves

Bachelor's degree in a health science, biological science, public health, psychology, or related field.
One year of administrative, healthcare, research, or customer service experience.
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.

Responsibilities

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.
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.
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.
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.
Participate in departmental meetings and training programs.
Complete required institutional training.
Perform other duties as assigned to support departmental research operations.