Clinical Research Coordinator - II

● Coordinate and schedule study assessments, procedures, and activities to ensure compliance with research protocols and timelines. Communicate effectively with internal teams, investigators, sponsors, and external partners to ensure protocol adherence.

● Assist in assessing subject eligibility and coordinating participant activities, including recruitment, informed consent, orientation, and follow-up correspondence.

● Schedule and coordinate subject visits, tests, and procedures; collaborate with external providers and diagnostic services as needed.

● Collect, document, and enter research data according to established protocols. Perform initial data analysis under the guidance of senior coordinators or the Principal Investigator (PI).

● Maintain accurate, complete, and timely records such as source documents, consent forms, case report forms (CRFs), regulatory binders, and protocol documentation.

● Conduct interviews and administer surveys, tests, or questionnaires to collect data from study participants. Review medical records to extract relevant information.

● Ensure the informed consent process is performed in compliance with FDA, GCP, IRB, HIPAA, and institutional policies. Maintain documentation of significant new findings communicated to participants.

● Assist in the preparation, submission, and tracking of IRB documents, including new protocols, continuing reviews, amendments, and reportable events.

● Support subject education and protocol compliance by reinforcing study requirements and providing clear, ongoing communication.

● Collaborate with pharmacy or materials management teams to track and reconcile investigational product (IP) usage and maintain specimen accountability.

● Assist with sample collection, processing, storage, and shipment according to study protocols and sponsor requirements.

● Help prepare for sponsor monitor visits, audits, and inspections. Respond to data queries and provide requested documentation in a timely manner.

● Contribute to grant application support, including gathering budgets, reports, and other required materials. May assist in drafting proposal components and communicating with funding agencies.

● Maintain and update automated tracking systems, databases, and regulatory records. Generate reports for compliance and operational review as needed.

Job Type: Full-time

Pay: $60,000.00 - $72,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person