Clinical Research Coordinator (Walhalla, SC)

Responsibilities

• Communicate with study participants regarding study objectives
• Conduct questionnaire administration and monitor participant compliance with study protocols
• Oversee study activities to ensure adherence to protocols, ethical conduct, and applicable regulatory standards
• Maintain research records of study activity, including case report forms, drug dispensation records or other regulatory forms as per FDA guidelines
• Manage clinical study and staff records related to clinical study activity
• Manage participant screening and recruitment by scheduling study visits, obtaining informed consent, and conducting protocol-required intake assessments
• Track and manage participant enrollment across all site clinical studies
• Prepare trial-related document support such as protocol worksheets, adverse event reports, IRB documents, procedural manuals, and progress reports
• Create, organize, and maintain essential study documentation and records to ensure accuracy and compliance
• Communicate ongoing study progress to the Clinical PI and Site Operations leads, including updates on recruitment, compliance, and overall study performance
• Stay updated on the latest research protocols and regulatory requirements to ensure compliance and contribute to the successful completion of the study
• Willingness to travel up to 25% as needed.

Qualifications

• Requires Bachelor’s degree in a relevant life science discipline
• 3+ years of previous experience working in clinical site/trials
• Bilingual in English and Spanish is a plus, but not required.
• Knowledge of FDA & ICH GCP regulations and guidelines is required
• Detail-oriented and meticulous in all aspects of work
• Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative
• Medical terminology and scientific knowledge are a plus
• Knowledge of standard clinical procedures and protocol
• Analytical mindset: needs analytical skills to collect and interpret data, taking note of patterns or outcomes that those in charge of the trial need to be aware of
• Excellent interpersonal skills, with the ability to effectively communicate and resolve issues while working with the PI, participants, and key stakeholders.
• Exceptional written and verbal communication skills, with the ability to clearly convey study requirements to participants and effectively liaise with site and management staff
• Skilled with standard computer programs including the MS Office suite.