Central Clinical Research Associate

Overview

The Central Clinical Research Associate serves as the primary liaison for Principal Investigators and site staff conducting rare disease registries. The role supports feasibility, study start-up, remote and onsite monitoring, site management, data quality, safety, regulatory compliance, study administration, stakeholder communication and international registry projects.

What you'll do

• Involve the Registries Team, Clinical Project Lead, Registries Regional Leads and Local Medical Affairs in site selection and feasibility activities.
• Collect, review and quality-check site and study documents for Health Authority, Regulatory Authority, Ethics Committee and Institutional Review Board submissions.
• Prepare Ethics Committee cover letters, additional submission materials and Insurance Certificate applications when applicable.
• Follow up with Ethics Committees on questions and inform sites when applicable.
• Support site contract activities from document collection through budget negotiation and final agreement.
• Customize, quality-review and track versions of Informed Consent Forms based on country requirements and site details when applicable.
• Upload and file study start-up documentation into the electronic Trial Master File.
• Keep parties informed about project progress, changes and issues.
• Plan, prepare, conduct, report and follow up remote and onsite Site Selection, Site Initiation, Routine Monitoring and Close Out Visits for sites and satellite sites.
• Perform remote and onsite site management in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs.
• Review study data remotely, perform source document checks, review electronic Case Report Form completeness and follow up on site query resolution.
• Escalate issues when necessary, maintain contact with Data Management and coordinate international data collection projects.
• Follow up on patient enrolment and patient status.
• Ensure site facilities meet protocol, local regulation, GCP and applicable SOP requirements.
• Ensure site staff training and access to different systems.
• Develop collaborative relationships with investigational sites and other stakeholders.
• Liaise with vendors for start-up and onsite monitoring activities.
• Ensure adequate site safety reporting and notification of safety information to Ethics Committees, Institutional Review Boards and Regulatory Authorities according to country regulations and site SOPs.
• Perform quality control of study conduct with an audit and inspection readiness mindset.
• Analyze issues and deviations, perform root cause analysis and implement Corrective and Preventive Actions when necessary.
• Maintain tables, trackers and databases updated to follow study progress locally and globally.
• Use all tools needed for the role.
• Participate in investigator, monitor, study, operational, quality audit, inspection, study set-up and training meetings when required.
• Ensure Trial Master File compliance throughout the study from set-up to archiving.
• Participate in investigator payment processes when applicable.
• Maintain study start-up timelines, monitoring visit frequency and monitoring quality.
• Support data quality and integrity, regulatory compliance, patient recruitment and retention, communication, collaboration, training and development, and timely and accurate CRA reporting.
• Identify stakeholders, keep them informed through updates, meetings and reports, build relationships, resolve conflicts, monitor compliance, and use stakeholder feedback to improve processes and outcomes.
• Seek alignment with internal and external stakeholders and Principal Investigators to prioritize registry activities and comply with approved processes.
• Support team initiatives and objectives, recommend process improvements and participate in company initiatives.

What you'll need

• 5+ years of experience in clinical research and development, including clinical trial monitoring experience.
• Degree in a Pharma/scientific discipline or a related Life Science degree.
• High proficiency in written and spoken English.
• Attention to detail for monitoring trial data and ensuring accuracy.
• Ability to address and resolve issues that arise during trials.
• Project management skills in managing timelines, budgets and resources.
• Proficiency in writing reports, protocols and regulatory documents.
• Experience working in global projects and an international matrix environment.
• Excellent written and oral communication skills.
• Ability to adapt to changing requirements and environments.
• Ability to build and maintain positive relationships with stakeholders.
• Efficient time management and task prioritization.
• Strong sense of ethics and integrity in conducting clinical research.
• Understanding of and adherence to Good Clinical Practice guidelines.
• Knowledge of regulatory requirements and guidelines, including FDA and EMA.
• Familiarity with clinical trial phases, protocols and methodologies.
• Skills in data collection, analysis and reporting.
• Proficiency in medical terminology and procedures.
• Competence with Microsoft Office products.

Nice to have

• Experience in rare diseases or observational studies.
• Real world evidence experience.

Details

• Location: Hyderabad.
• The role includes remote site management and onsite site management where local hub affiliates are located.
• Participation in local and international meetings may be required.