Job Description:
The Clinical Research Specialist (CRS) is responsible for supporting and overseeing clinical trial activities across Phase I IV studies, ensuring compliance with study protocols, Good Clinical Practice (ICH-GCP), Standard Operating Procedures (SOPs), and applicable regulatory requirements. The CRS collaborates closely with Clinical Operations, Medical Affairs, Clinical Scientists, Investigators, CROs, and study site personnel to ensure subject safety, data integrity, and successful execution of clinical research programs.
Responsibilities:
Clinical Trial Management & Site Oversight:
- 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.
- 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).
- 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.
- 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.
- Monitor investigational product/device receipt, storage, dispensing, accountability, reconciliation, and return activities.
- Ensure compliance with study-specific investigational product management requirements.
- 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.
- 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.
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biotechnology, Clinical Research, or a related scientific discipline.
- Master's degree is preferred.
- 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.
- 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).
- 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.
- 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
