Central Clinical Research Associate

Overview

Central Clinical Research Associate (CRA) serving as the primary liaison for the Principal Investigator and site staff conducting rare disease registries at investigational sites.

What you'll do

• Take part in site selection together with the Registries Team.
• Assist in collecting site documents for submission to Health Authorities/Regulatory Authorities and Ethics Committees/Institutional Review Boards.
• Review and ensure the quality of site and study documents prior to submission to central, local and hospital committees and HA/RA.
• Prepare EC cover letters and any additional required materials, if applicable.
• Follow up with EC on additional queries and communicate updates to sites, if applicable.
• Prepare the Insurance Certificate application, when applicable.
• Support the Site Contract process, including collection of required site documents, budget negotiations and final agreement with sites.
• Ensure customization of the Informed Consent Form (ICF) for country-specific requirements, incorporating site details, and conduct quality reviews and version tracking per site, if applicable.
• Assist with uploading and filing Study Start-up documentation into the electronic Trial Master File (eTMF).
• Keep all stakeholders informed about project progress, changes and arising issues.
• Perform remote site management and related activities on assigned registries in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs.
• Plan, prepare, conduct, report and follow up site (and satellite site) visits, including Site Selection, Site Initiation, Routine Monitoring and Close Out Visits, according to Study manual, Protocol, Local Regulation, GCP and SOPs.
• Where local hub affiliates are located, perform onsite site management and related activities on assigned registries in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs.
• Review study data from various sources remotely; follow up trial progress and perform quality control of data (source document check).
• Review eCRF completeness and query resolution by sites; escalate issues when necessary.
• Maintain contact with the Data Management group and coordinate international data collection projects.
• Follow up on patient enrolment and patient status.
• Ensure site facilities are adequate according to protocol needs, local regulations, GCP and applicable SOPs; ensure site staff training and access to systems.
• Develop collaborative relationships with investigational sites and other stakeholders.
• Liaise with vendors for activities such as study start-up and onsite monitoring.
• Ensure adequate safety reporting processes at the site and that the site submits and/or notifies safety information to EC/IRB/RA according to country regulations and site SOP.
• Perform quality control of study conduct at site level with an audit/inspection readiness mindset; carry out root cause analysis of issues and deviations and implement Corrective and Preventive Actions (CAPA) when necessary.
• Keep all tables, trackers and databases updated to follow study progress locally and globally; know and use all required tools.
• Participate in the investigator payment process, if applicable.
• Ensure TMF compliance by contributing to the eTMF process throughout the study, from set-up to archiving, including collection of required site documents.
• Participate in local and international investigator and/or monitor meetings (where required), study/operational meetings, quality audits and inspections, study set-up meetings and trainings.
• Seek alignment with internal stakeholders, external stakeholders or the Principal Investigator to ensure integration and prioritization of Registry study activities and compliance with approved processes.
• Support team initiatives and objectives, identify and recommend process improvements, and participate in company initiatives.
• Manage conflicts between stakeholders, communicate regularly with stakeholders, and monitor compliance with regulatory and ethical guidelines.

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, problem-solving, project management and technical writing skills.
• Experience working in global projects and an international matrix environment.
• Excellent written and oral communication, adaptability, interpersonal skills, time management and ethical judgment.
• Understanding of and adherence to Good Clinical Practice (GCP).
• Knowledge of regulatory requirements and guidelines (FDA, EMA, etc.).
• Familiarity with clinical trial phases, protocols and methodologies.
• Skills in data collection, analysis and reporting; proficiency in medical terminology and procedures.
• Competent with Microsoft Office products.

Nice to have

• Experience with rare diseases or observational studies, and real world evidence experience.

Details

• Location: Hyderabad.
• Travel required as per business need.
• Permanent, full-time role.