Clinical Research Coordinator II

Overview : Responsible for the daily operations and overall management of assigned clinical trials, including administrative duties and regulatory functions. This role requires clear and direct communication with study sponsors, monitors, CROs, principal investigators (PIs), and site management. The CRC II also supports and guides CRC Is on site standard operating procedures (SOPs), study protocols, and regulatory compliance. The individual in this position must demonstrate professionalism, ethical conduct, and problem-solving skills when challenges arise. Overview :

Responsible for the daily operations and overall management of assigned clinical trials, including administrative duties and regulatory functions. This role requires clear and direct communication with study sponsors, monitors, CROs, principal investigators (PIs), and site management. The CRC II also supports and guides CRC Is on site standard operating procedures (SOPs), study protocols, and regulatory compliance. The individual in this position must demonstrate professionalism, ethical conduct, and problem-solving skills when challenges arise.

Responsibilities

• Manage and oversee enrollment of clinical trials according to protocol and identify strategies to exceed enrollment goals.
• Collaborate with the recruitment department and site management to determine best recruitment practices for assigned studies.
• Inform patients or caregivers about studies and associated procedures.
• Monitor study activities to ensure compliance with protocols and all relevant local, federal, and institutional regulations.
• Maintain assigned study e-regulatory binders and ensure all required documentation is accurate and complete.
• Follow all site policies, SOPs, and controlled documents; assist CRC Is with guidance and training as needed.
• Schedule study visits and monitoring activities according to protocol and study plan.
• Complete source documentation in real time during patient visits, ensuring accuracy and adherence to good documentation practices.
• Enter source data into the electronic data capture (EDC) system within one business day of the patient visit; resolve data queries within 48 hours.
• Maintain adequate inventory of laboratory and study supplies to support ongoing enrollment and study visits.
• Attend investigator meetings and site initiation visits, collecting and sharing pertinent study information with the team.
• Maintain accurate and complete study records, including case report forms and drug accountability logs.
• Perform study procedures such as vital signs, ECGs, and specimen collection as required by protocol.
• Communicate laboratory findings and adverse event information to investigators, ensuring timely reporting and documentation.
• Manage data entry and ensure all study timelines are met.
• Handle requisition, labeling, storage, and shipment of specimens per protocol.
• Dispense investigational products or medical devices as required, ensuring accurate calculation of dosages and proper documentation.
• Identify, report, and resolve protocol deviations and unanticipated events.
• Maintain investigational product (IP) accountability and ensure secure, restricted storage.
• Maintain study master logs (e.g., informed consent, patient ID, enrollment, delegation, and training logs).
• Participate in site quality assurance audits as needed.
• Ensure proper handling and awareness of all safety reports, confirming PI review and required signatures.
• Maintain strict confidentiality of participant protected health information (PHI) and sponsor data.
• Perform other duties as assigned.

Education and Experience

This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.