Clinical Research Coordinator

Job Summary:
We are looking for a detail-oriented and organized Clinical Research Coordinator to support the planning, execution, documentation, and monitoring of clinical trials. The candidate will coordinate with investigators, study participants, sponsors, CROs, and other study teams to ensure clinical research activities are conducted according to the protocol, ICH-GCP, and applicable regulatory requirements.

Key Responsibilities:

• Coordinate day-to-day activities of clinical research studies at the site.
• Assist Principal Investigators and study teams in conducting clinical trials.
• Screen and recruit eligible study participants according to the study protocol.
• Schedule participant visits, assessments, and follow-ups.
• Maintain accurate and complete study-related documentation and records.
• Assist with informed consent procedures in accordance with the approved protocol.
• Collect, document, and maintain clinical trial data accurately.
• Complete and maintain Case Report Forms (CRFs/eCRFs) and source documents.
• Coordinate with sponsors, CROs, monitors, laboratories, and other study personnel.
• Ensure study activities are conducted according to the protocol, ICH-GCP, SOPs, and applicable regulations.
• Support Site Initiation Visits (SIVs), Monitoring Visits, and Close-Out Visits.
• Track and report adverse events and serious adverse events as required.
• Maintain Investigator Site Files (ISF) and other essential study documents.
• Assist with regulatory submissions and ethics committee documentation.
• Track study supplies, investigational products, laboratory samples, and equipment.
• Identify and escalate protocol deviations and other study issues.
• Participate in audits and inspections when required.

Required Skills:

• Good understanding of Clinical Research, ICH-GCP, clinical trial processes, and research ethics.
• Knowledge of informed consent and patient/participant recruitment procedures.
• Understanding of source documentation and CRF/eCRF completion.
• Strong organizational and documentation skills.
• Excellent communication and interpersonal skills.
• Good attention to detail and ability to manage multiple tasks.
• Basic knowledge of MS Office, particularly Word and Excel.
• Ability to work effectively with investigators, patients, sponsors, and CRO teams.