Clinical Research Coordinator

Position Overview

We are seeking a qualified and detail-oriented Clinical Research Coordinator to support and coordinate clinical research activities across ongoing and upcoming clinical trials. The ideal candidate will have an MBBS qualification, a strong understanding of clinical research processes, and the ability to work effectively with investigators, study teams, sponsors, and other stakeholders.

The Clinical Research Coordinator will be responsible for supporting patient screening and recruitment, study feasibility, research documentation, data management, protocol compliance, regulatory activities, and coordination of remote clinical research operations. The role requires strong attention to detail, effective communication skills, and a commitment to maintaining research integrity, participant safety, and compliance with applicable clinical research standards.

Key Responsibilities1. Patient Screening & Recruitment Support

• Review medical records and patient information to identify potential study participants.
• Conduct pre-screening activities based on study-specific inclusion and exclusion criteria.
• Conduct outbound calls to potential candidates to screen them for participation in clinical trial studies.
• Explain basic study information, eligibility requirements, visit expectations, and other relevant study details to potential participants in a clear and professional manner.
• Conduct initial telephone screening and accurately document participant responses and screening outcomes.
• Support patient recruitment and enrollment activities in coordination with investigators and study teams.
• Assist with reviewing patient medical histories and relevant clinical information for study eligibility.
• Maintain accurate records of screening, recruitment, and participant communication activities.
• Escalate potential safety concerns, eligibility issues, or other relevant findings to the appropriate study team member.

2. Clinical Trial Coordination

• Coordinate day-to-day clinical research activities in accordance with approved study protocols.
• Support investigators and study teams in the execution of clinical trial activities.
• Coordinate communication between study sites, investigators, sponsors, CROs, and other stakeholders.
• Track study-related activities, timelines, deliverables, and pending actions.
• Ensure assigned research activities are completed accurately and within established timelines.

3. Feasibility & Study Start-Up

• Complete and support the preparation of clinical trial feasibility questionnaires.
• Review study requirements and assess site capabilities against protocol requirements.
• Assist with collecting information related to patient populations, available resources, clinical expertise, and study infrastructure.
• Support study start-up activities and ensure required information is provided to sponsors and research partners in a timely manner.

4. Data Management & Documentation

• Assist with the collection, review, and maintenance of accurate clinical research data.
• Support the completion and review of Case Report Forms (CRFs) and electronic data capture (EDC) systems.
• Maintain essential study documents and ensure appropriate version control.
• Review data for completeness, consistency, and potential discrepancies.
• Support query resolution and follow-up with relevant study personnel.

5. Protocol & GCP Compliance

• Ensure clinical research activities are conducted in accordance with approved study protocols.
• Follow Good Clinical Practice (GCP) guidelines and applicable regulatory requirements.
• Identify and escalate protocol deviations, data discrepancies, and compliance concerns.
• Maintain a strong focus on participant safety, confidentiality, and research integrity.
• Support the implementation of corrective and preventive actions where required.

6. Regulatory & Ethics Support

• Assist with preparation and organization of documentation for Institutional Review Board (IRB)/Ethics Committee submissions.
• Support the preparation of regulatory and study-specific documentation.
• Maintain regulatory files and essential documents in accordance with study requirements.
• Assist with documentation required for monitoring visits, audits, and inspections.
• Ensure regulatory documentation remains accurate, complete, and up to date.

7. Remote Clinical Research Support

• Provide remote support for clinical research activities that do not require physical presence at the study site.
• Coordinate communications between investigators, site teams, sponsors, CROs, and offshore research personnel.
• Monitor assigned tasks and follow up on outstanding study activities.
• Prepare regular status updates and reports for internal and external stakeholders.
• Escalate potential delays, risks, or operational challenges in a timely manner.

8. Training & Knowledge Support

• Provide clinical and research-related guidance to study coordinators and research staff where appropriate.
• Support training on study protocols, documentation requirements, and research processes.
• Share medical knowledge to promote accurate protocol interpretation and patient safety.
• Assist in developing or updating research-related training materials and process documentation.

9. Communication & Reporting

• Maintain clear and professional communication with internal and external stakeholders.
• Prepare study progress reports, trackers, and status updates.
• Participate in research meetings and provide updates on assigned activities.
• Proactively identify issues that may impact study timelines, data quality, or compliance.
• Maintain appropriate documentation of study-related communications and decisions.

Qualifications

• MBBS degree
• Strong understanding of clinical research principles, patient care, and clinical terminology.
• Understanding of Good Clinical Practice (GCP) and clinical trial processes.
• Excellent written and verbal English communication skills.
• Strong telephone communication and patient interaction skills.
• Strong analytical, organizational, and documentation skills.
• Proficiency in Microsoft Office, particularly Excel, Word, and PowerPoint.
• Ability to work independently and effectively in a remote or offshore environment.
• Strong attention to detail and ability to manage confidential information.
• Prior experience in clinical research, clinical trials, medical research, patient recruitment, or a related field is preferred but not mandatory.

Preferred Skills & Experience

• Familiarity with Electronic Data Capture (EDC) systems and clinical trial management systems.
• Experience with patient chart/medical record review.
• Experience conducting telephone-based patient screening or recruitment.
• Experience preparing or reviewing regulatory and ethics documentation.
• Knowledge of clinical trial terminology, CRFs, informed consent documentation, and study protocols.
• Familiarity with IRB/Ethics Committee submission processes.
• Understanding of clinical trial feasibility and site selection processes.
• Strong interpersonal and telephone communication skills.
• Ability to manage multiple studies, priorities, and deadlines simultaneously.
• Experience working with international clinical research teams or U.S.-based stakeholders is an advantage.

Core Competencies

• Clinical & Medical Knowledge
• Clinical Research Coordination
• Patient Screening & Recruitment
• Telephone Screening & Communication
• Protocol Compliance
• Attention to Detail
• Data Accuracy & Documentation
• Regulatory Awareness
• Stakeholder Management
• Time Management & Organization
• Problem Solving
• Confidentiality & Ethical Conduct
• Proactive Ownership
• Team Collaboration

Benefits

• Flexible working environment.
• Opportunity to work with international clinical research teams.
• Exposure to global clinical trial practices and research standards.
• Professional development and learning opportunities.
• Experience across clinical research coordination, patient recruitment, feasibility, regulatory support, and study operations.
• Opportunity to contribute to the growth of a rapidly developing clinical research function.

Work Location: In person