Clinical Research Specialist

• Support the planning, initiation, conduct, monitoring, and closeout of clinical studies.
• Coordinate with investigators, study coordinators, CROs, and internal stakeholders to ensure successful study execution.
• Participate in site feasibility assessments, qualification visits, site initiation visits, monitoring visits, and closeout activities.
• Track study progress, enrollment, retention, and site performance metrics.

Clinical Monitoring & Data Quality:

• Review and verify source documentation, case report forms (CRFs/eCRFs), informed consent forms, and study records.
• Ensure accuracy, completeness, and integrity of clinical trial data in compliance with ALCOA principles.
• Monitor protocol compliance and identify protocol deviations, discrepancies, and data quality issues.
• Assist in resolving data queries and implementing corrective and preventive actions (CAPA).

Regulatory & Compliance Activities:

• Ensure studies are conducted in accordance with ICH-GCP guidelines, FDA, EMA, and applicable local regulations.
• Review and maintain essential regulatory documentation and study files.
• Support audit and inspection readiness activities and participate in sponsor and regulatory authority inspections.
• Assist in preparation and review of clinical and regulatory documents.

Safety Monitoring:

• Review adverse events (AEs), serious adverse events (SAEs), concomitant medications, laboratory data, and safety parameters.
• Escalate significant safety concerns to appropriate medical and clinical leadership.
• Support safety review meetings, DSMB/DMC activities, and risk management initiatives.

Investigational Product Accountability:

• Monitor investigational product/device receipt, storage, dispensing, accountability, reconciliation, and return activities.
• Ensure compliance with study-specific investigational product management requirements.

Cross-Functional Collaboration:

• Work closely with Clinical Operations, Clinical Scientists, Biometrics, Pharmacovigilance, Regulatory Affairs, Data Management, Medical Affairs, and external vendors.
• Serve as a key liaison between sponsors, CROs, and clinical sites.
• Provide training and support to site personnel regarding protocol requirements and study procedures.

Documentation & Reporting:

• Prepare monitoring reports, study updates, status reports, and other clinical documentation in a timely manner.
• Maintain Clinical Trial Management Systems (CTMS), eTMF, and other study tracking systems.
• Support database lock activities and study closeout processes.

Qualifications:

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biotechnology, Clinical Research, or a related scientific discipline.
• Master's degree is preferred.

Experience:

• 3–7 years of experience in Clinical Research, Clinical Operations, Clinical Monitoring, or related clinical development functions.
• Experience supporting Phase I–IV clinical trials preferred.
• Experience working with CROs, investigators, and clinical trial sites.

Required Skills:

• Strong knowledge of ICH-GCP guidelines and clinical research regulations.
• Understanding of clinical trial processes and drug/device development lifecycle.
• Experience with CTMS, eTMF, EDC, and other clinical systems.
• Knowledge of adverse event reporting and clinical safety processes.
• Strong analytical, problem-solving, and organizational skills.
• Excellent verbal and written communication skills.
• Ability to manage multiple studies and priorities simultaneously.
• Strong stakeholder management and relationship-building abilities.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

Preferred Qualifications:

• Clinical monitoring experience as CRA or Sr. CRA.
• Experience in pharmaceutical, biotechnology, CRO, or medical device industries.
• Familiarity with Risk-Based Monitoring (RBM) and Risk-Based Quality Management (RBQM) methodologies.
• Experience supporting regulatory submissions and inspection readiness activities.

Core Competencies:

• Clinical Trial Management.
• Site Management & Monitoring.
• Regulatory Compliance.
• Clinical Data Review.
• Safety Surveillance.
• Investigational Product Accountability.
• Risk Management.
• Cross-Functional Collaboration.
• Problem Solving & Critical Thinking.
• Communication & Stakeholder Management.