Senior Clinical Research Associate

Responsibilities:

Independent Site Monitoring & Management 

• Conduct and document all types of monitoring visits
• Perform comprehensive source data verification (SDV), source data review (SDR), protocol compliance checks, safety data review, and regulatory oversight.
• Utilize a risk-based monitoring approach to identify trends, assess site performance, and proactively mitigate operational challenges.
• Provide continuous operational support to sites, ensuring timely data entry, query resolution, and audit readiness.

 Protocol & GCP Compliance

• Ensure investigative sites adhere strictly to ICH-GCP, local regulations, study SOPs, and protocol-specific requirements.
• Identify, document, and escalate protocol deviations, safety non-compliance, and data risks.
• Support sites in implementing corrective and preventive action plans (CAPAs).

Safety Oversight 

• Verify accuracy, completeness, and timeliness of AE/SAE documentation.
• Ensure sites follow appropriate safety reporting pathways and timelines. 

Investigational Product (IP) Accountability 

• Conduct detailed IP accountability checks, including temperature excursion assessments, dispensing logs, and IRT/IVRS reconciliation.
• Support sites in proper storage, handling, and documentation of all investigational supplies. 

Study Start-Up & Close-Out 

• Conduct qualification assessments, feasibility engagements, and site readiness reviews.
• Train site personnel on protocol updates, study systems, operational workflows, and safety reporting requirements.
• Lead the site through regulatory completion activities, archiving, and closure documentation.

 Documentation & Reporting 

• Prepare high-quality monitoring visit reports, follow-up letters, and site correspondence within required timelines.
• Maintain accurate, audit-ready documentation in eTMF or sponsor-designated systems.
• Ensure that all site activities are appropriately tracked, communicated, and escalated where necessary.

 Cross-Functional Collaboration

•  Collaborate with Project Managers, Data Managers, Safety teams, Start-Up Specialists, Medical Monitors, and other CRAs.
• Contribute to study-level risk assessments, monitoring strategies, and operational readiness reviews. • Participate in investigator meetings, site training sessions, and process improvement initiatives.

 Leadership, Coaching & Oversight 

•  Mentor junior CRAs and assist in the evaluation of CRA performance where required. Conduct co-monitoring visits, provide feedback, and help new CRAs transition to independent monitoring.
• Represent the CRA team during internal meetings and sponsor interactions. 

Requirements:

• Bachelor’s or Master’s degree in Life Science, Pharmacy, Nursing, or related field.
• 4–6 years of direct, hands-on monitoring experience in Phase I–IV clinical trials.
• Demonstrated success in managing high-enrolling, difficult, or rescue sites.
• Experience in at least one major therapeutic area (Oncology preferred; others include Infectious Diseases, Vaccines, CNS, Cardiovascular, Endocrinology).
• Strong proficiency with EDC systems (Veeva Vault, Medidata Rave, Oracle Inform, Viedoc, REDCap).
• Solid understanding of eTMF platforms and sponsor-specific documentation systems.
• Strong knowledge of ICH-GCP, regulatory guidelines, trial master file (TMF) requirements, and quality expectations. 
• Behavioral Competencies 
• Exceptional communication and relationship-building skills.
• Strong analytical, problem-solving, and critical-thinking ability.
• High attention to detail paired with excellent time management.
• Comfortable working independently and making informed decisions under pressure. 
• Committed to continuous learning and operational excellence. 

What We Offer

• Competitive salary and performance-based rewards
• Comprehensive medical and wellness benefits 
• Flexible or hybrid working arrangements