Position Summary: The Clinical Research Coordinator (CRC) is responsible for the coordination and administration of clinical research activities under the direction of the Principal Investigator (PI). The CRC ensures compliance with protocol guidelines, proper documentation, and adherence to regulatory requirements in conducting clinical trials. The CRC plays a key role in managing the day-to-day operations of clinical studies, from patient recruitment and consent to data collection and reporting.
Key Responsibilities:
- Coordinate and oversee all aspects of clinical trials, including participant recruitment, screening, enrollment, and follow-up.
- Obtain informed consent from study participants and ensure that ethical standards are maintained throughout the study.
- Manage study-related documentation, including case report forms, informed consent documents, and regulatory binders.
- Assist in the development and implementation of study protocols, procedures, and data collection instruments.
- Monitor and report adverse events and protocol deviations to the Principal Investigator and regulatory bodies as required.
- Ensure accurate and timely data entry, data quality control, and resolution of data queries.
- Serve as the primary point of contact for study participants, ensuring their questions and concerns are addressed.
- Coordinate study visits, including scheduling, preparation of study materials, and collection of biological samples.
- Participate in study team meetings, providing updates on study progress and addressing any issues that arise.
- Assist with study closeout procedures, including data analysis, final reporting, and archiving of study materials.
Qualifications:
- Bachelor’s degree in a related field (e.g., life sciences, nursing, public health) required; Master’s degree preferred.
- Certification as a Clinical Research Coordinator (CCRC) or Clinical Research Professional (CCRP) is highly desirable.
- Strong understanding of clinical trial processes, GCP, and regulatory requirements.
- Excellent organizational and time-management skills, with the ability to manage multiple tasks simultaneously.
- Strong communication and interpersonal skills, with the ability to work effectively in a team environment.
- Proficiency in Microsoft Office Suite and clinical trial management software.
