Clinical Research Specialist

Katalyst CRO; Guntur District; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Katalyst CRO is seeking a Clinical Research Specialist to support and oversee clinical trial activities across multiple phases, ensuring GCP compliance and data integrity. The role collaborates with Clinical Operations, Medical Affairs, investigators and CROs to ensure patient safety and successful execution of trials.

The CRS will monitor data quality, assist in CAPA implementation, and support regulatory submissions and inspections while coordinating with site personnel and internal teams

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Biotechnology, Clinical Research or related field.
• Master’s degree preferred.

Responsibilities

• Support planning, initiation, conduct, monitoring and closeout of clinical studies.
• Coordinate with investigators, CROs and stakeholders for study execution.
• Participate in site feasibility, qualification visits, initiation visits, monitoring visits and closeout activities.
• Track study progress, enrollment, retention and site performance metrics.
• Review source documentation, CRFs/eCRFs, informed consent and study records for accuracy and integrity.
• Ensure data quality per ALCOA principles and resolve data queries.
• Assist in regulatory document preparation and inspection readiness activities.
• Escalate safety concerns and support safety review meetings and risk management.
• Monitor investigational product receipt, storage, accountability and reconciliation.
• Provide training and support to site personnel on protocol requirements.
• Prepare monitoring reports, updates and CTMS/eTMF documentation.

Skills

ICH-GCP knowledge

Clinical trial processes

Regulatory understanding

Data review & QC

Stakeholder management

Analytical skills

Communication skills

MS Office

Education

Bachelor's in Life Sciences/related

Master's preferred

Tools

CTMS

eTMF

EDC

Job description

Job Description

The Clinical Research Specialist (CRS) is responsible for supporting and overseeing clinical trial activities across Phase IIV 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.

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

• 37 years of experience in Clinical Research, Clinical Operations, Clinical Monitoring, or related clinical development functions.
• Experience supporting Phase IIV 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