Clinical Research Associate

Job Description

• We are seeking a detail-oriented, organized, and scientifically knowledgeable Clinical Research Associate (CRA) to support and oversee clinical research studies, ensuring that trials are conducted in accordance with approved study protocols, Good Clinical Practice (GCP), applicable regulatory requirements, and ethical standards.
• The successful candidate will be responsible for monitoring clinical trial sites, verifying the accuracy and completeness of clinical data, ensuring participant safety and rights, reviewing study documentation, and supporting the quality and integrity of clinical research activities.
• The ideal candidate should have a strong understanding of clinical research methodologies, regulatory compliance, clinical trial documentation, and site monitoring procedures, with excellent communication and analytical skills.

Key Responsibilities

• Conduct site initiation, routine monitoring, and close-out visits for clinical trials in accordance with study protocols and monitoring plans.
• Ensure clinical research activities comply with Good Clinical Practice (GCP), applicable regulatory requirements, and institutional policies.
• Monitor clinical trial sites to verify adherence to approved protocols, informed consent procedures, and participant eligibility criteria.
• Review clinical trial documentation, source records, case report forms, and electronic data capture (EDC) systems for accuracy, completeness, and consistency.
• Verify that informed consent is properly obtained and documented before participants undertake study-specific procedures.
• Monitor participant safety and ensure that adverse events and serious adverse events are documented, reported, and escalated within required timelines.
• Assess investigational product accountability, storage conditions, handling procedures, and documentation where applicable.
• Identify protocol deviations, data discrepancies, non-compliance, and potential risks, and work with site teams to implement corrective and preventive actions.
• Prepare and maintain monitoring visit reports, follow-up letters, site documentation, and other essential clinical trial records.
• Support site feasibility assessments, site selection, study initiation, recruitment monitoring, and trial close-out activities.
• Collaborate with principal investigators, study coordinators, clinical research teams, data managers, medical monitors, and sponsors to support trial progress.
• Track study milestones, recruitment targets, outstanding data queries, and site action items to help ensure timely study delivery.
• Support regulatory document collection and maintenance of the Trial Master File (TMF) and Investigator Site File (ISF).
• Assist with audit and inspection preparation, respond to monitoring findings, and follow up on corrective actions.
• Maintain accurate records and ensure the confidentiality, integrity, and secure handling of clinical trial data and participant information.
• Identify potential study risks and escalate significant issues to the appropriate study management personnel.
• Stay updated on clinical research regulations, GCP requirements, ethical guidelines, and evolving clinical trial practices.

Education

• Bachelor's degree in Nursing, Pharmacy, Medicine, Biological Sciences, Biomedical Sciences, Public Health, or another relevant life sciences discipline.
• A postgraduate qualification in Clinical Research, Public Health, Epidemiology, or a related field will be an added advantage.
• Current training in ICH Good Clinical Practice (GCP) is highly desirable and may be required before undertaking study-monitoring responsibilities.
• Relevant professional certifications in clinical research, clinical trial management, or research ethics are advantageous.
• Equivalent relevant clinical research experience and demonstrable knowledge may be considered, subject to applicable regulatory and employer requirements.

Experience:

• 2 - 4 years of relevant experience in clinical research, clinical trial coordination, clinical monitoring, or a related research role.
• Demonstrable experience supporting or monitoring clinical trials in accordance with study protocols and GCP requirements.
• Experience reviewing source documentation, clinical data, informed consent records, and essential study files.
• Familiarity with site monitoring activities, data query resolution, protocol deviation management, and study documentation.
• Experience preparing monitoring reports, tracking outstanding actions, and supporting audit readiness.
• Understanding of participant safety reporting and clinical trial quality management.
• Experience working with investigators, clinical research coordinators, sponsors, contract research organizations (CROs), or research institutions.
• Willingness to travel to clinical trial sites when required, subject to the role's monitoring responsibilities.

Required Skills:

• Strong understanding of clinical research methodologies, clinical trial phases, and study protocols.
• Knowledge of Good Clinical Practice (GCP), ethical research principles, and applicable clinical trial regulations.
• Understanding of informed consent procedures, participant eligibility, safety reporting, and protocol compliance.
• Experience reviewing clinical data, source documents, case report forms, and essential study documentation.
• Familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Knowledge of adverse event and serious adverse event reporting requirements.
• Understanding of clinical trial monitoring procedures, site management, and data quality assurance.
• Strong analytical skills and attention to detail when identifying inconsistencies, risks, and protocol deviations.
• Excellent written and verbal communication skills for interacting with investigators, site staff, sponsors, and research teams.
• Strong organizational, documentation, and time-management skills.
• Ability to manage multiple clinical trial sites, competing priorities, and study deadlines.
• Ability to prepare clear monitoring reports and maintain accurate audit trails.
• High ethical standards, professional integrity, and commitment to participant safety and confidentiality.
• Proficiency in Microsoft Office applications, particularly Word, Excel, and Outlook.

Additional Advantage:

• Experience with clinical trial systems such as Medidata Rave, Oracle Clinical One, Veeva Vault Clinical, or equivalent platforms.
• Familiarity with risk-based monitoring (RBM), centralized monitoring, and remote monitoring practices.
• Knowledge of electronic Trial Master File (eTMF) systems and clinical trial documentation standards.
• Experience in therapeutic areas such as oncology, cardiology, infectious diseases, vaccines, or other specialized fields.
• Understanding of clinical data management, medical terminology, and pharmacovigilance processes.
• Training or certification in ICH-GCP, clinical research, or clinical trial monitoring.