Clinical Research Associate II, Client Based

This is a fully remote position, open to applicants in India.

📋 Description

• Execute site qualification, initiation, interim monitoring, management, and close-out visits either on-site or remotely.

• Assess site and staff performance, providing recommendations for site-specific actions.

• Communicate or escalate critical issues and formulate action plans accordingly.

• Verify informed consent, maintain subject confidentiality, ensure safety, clinical data integrity, protocol compliance, and address pharmacovigilance matters.

• Conduct reviews of source documents and validate clinical data in case report forms.

• Address queries both remotely and on-site while guiding site staff effectively.

• Assist in the review, capture, and compliance of clinical study data and electronic data capture.

• Oversee the management of investigational product inventory, including reconciliation, storage, dispensing, administration, and related regulatory obligations.

• Review Investigator Site Files and ensure they align with Trial Master Files.

• Document monitoring activities through letters, reports, logs, and project documentation.

• Aid in subject/patient recruitment, retention, and awareness initiatives.

• Monitor observations, site status, and action items closely.

• Manage site-level operations, communications, budgets, timelines, deliverables, and project objectives.

• Serve as a liaison with study site personnel, ensuring that assigned sites and project staff are adequately trained and compliant.

• Participate in investigator, sponsor, global monitoring, project, and clinical training meetings.

• Facilitate audit readiness, preparation, and follow-up actions.

• For Real World Late Phase: provide support to sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates and local staff, train junior staff, identify out-of-scope activities, and propose potential sites.

⛳️ Requirements

• At least 3 years of on-site monitoring experience in Global Clinical Trials.

• 1–2 years of experience in Oncology is preferred.

• Experience in Neuroscience, Haematology, Cardiovascular, or Rare Disease is preferred.

• Bachelor’s degree or RN in a relevant field, or a comparable combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Proficient computer skills and a willingness to adopt new technologies.

• Outstanding communication, presentation, and interpersonal abilities.

• Capability to manage travel requirements of up to 75% regularly.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• Inclusive company culture.

• Remote work opportunities.