Clinical Research Coordinator

Busy research department within a multi specialty ophthalmology practice in search of experienced clinical research coordinator- eye experience preferred but not needed.

Join of the most prolific eye research facilities in the state!

Duties

Study Coordination

• Coordinate and implement clinical research studies according to approved protocols.
• Schedule and conduct study visits with participants.
• Maintain study timelines and track project milestones.
• Facilitate communication between investigators, sponsors, monitors, and participants.

Participant Management

• Recruit, screen, and enroll eligible study participants.
• Obtain and document informed consent.
• Educate participants about study procedures, risks, and expectations.
• Monitor participant compliance and retention throughout the study.
• Address participant questions and concerns.

Data Collection and Documentation

• Collect and record study data accurately and timely.
• Complete case report forms (CRFs) and electronic data capture (EDC) systems.
• Maintain source documentation and research records.
• Ensure data quality and resolve data discrepancies.

Regulatory Compliance

• Ensure compliance with study protocols, institutional policies, and regulatory requirements.
• Prepare and submit documents to Institutional Review Boards (IRBs) and ethics committees.
• Maintain regulatory binders and essential study documents.
• Report protocol deviations, adverse events, and serious adverse events as required.

Study Monitoring and Quality Control

• Prepare for sponsor and regulatory audits or monitoring visits.
• Respond to monitoring findings and implement corrective actions.
• Conduct quality assurance checks on study data and documentation.
• Ensure adherence to Good Clinical Practice (GCP) guidelines.

Investigational Product Management

• Receive, store, track, and document investigational drugs or devices.
• Maintain accountability logs.
• Coordinate dispensing and return of study products according to protocol requirements.

Administrative Responsibilities

• Manage study supplies and equipment.
• Maintain confidential participant information in accordance with privacy regulations.
• Advising director or principal investigator of concerns.

Safety Oversight

• Monitor and document adverse events and safety information.
• Notify investigators and sponsors of safety concerns.
• Ensure participant safety throughout the study.

Common Skills Required

• Knowledge of clinical research regulations (GCP, FDA, ICH guidelines).
• Strong organizational and project management skills.
• Attention to detail and documentation accuracy.
• Effective communication and interpersonal skills.
• Experience with electronic medical records (EMR) and clinical trial management systems (CTMS).
• Ability to manage multiple studies simultaneously.

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off

Work Location: In person