CRA (Level II) in भारत

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a CRA (Level II) based in India. This role offers the opportunity to support clinical trials at the intersection of scientific rigor, patient safety, and data quality. You’ll coordinate clinical monitoring and site management activities across assigned studies and investigative sites. The position combines remote and on-site monitoring with close collaboration across clinical, client, and project teams. You’ll apply risk-based monitoring, critical thinking, and root-cause analysis to identify and resolve site-level issues. Your work will help ensure trials follow approved protocols, ICH-GCP standards, regulatory requirements, and applicable procedures. You’ll also contribute to audit readiness, investigator relationships, study documentation, and ongoing process improvements. The role involves significant travel and is suited to an experienced CRA who can work independently while contributing effectively to a global team. Accountabilities - Conduct remote and on-site monitoring visits using a risk-based monitoring approach, assessing protocol compliance, data quality, investigational product accountability, and site processes. - Perform source data review, source data verification, CRF review, and essential document checks as required by study specifications. - Identify site deficiencies and risks through critical thinking and root-cause analysis, recommend corrective and preventive actions, and follow issues through to resolution. - Maintain regular communication with investigative sites between monitoring visits to support protocol adherence, timely data entry, and resolution of previously identified findings. - Initiate clinical trial sites, support investigator identification and meetings, and contribute to site close-out activities and retrieval of trial materials. - Ensure essential documents are complete and maintained in accordance with ICH-GCP and applicable regulatory requirements.

- Provide study status updates, progress reports, and accurate information in clinical trial management systems. - Facilitate effective communication between investigative sites, project teams, and clients through written, verbal, and electronic communication. - Respond to applicable company, client, regulatory, audit, and inspection requirements. - Complete administrative activities, including expense reports and timesheets, accurately and on time. - Contribute to project tools, publications, process improvements, and other initiatives that strengthen clinical trial delivery and team effectiveness. Requirements - Bachelor’s degree in a life sciences-related field, Registered Nursing certification, or an equivalent relevant academic or vocational qualification. - At least 2 years of on-site clinical monitoring experience, with a background that provides the knowledge and skills required for the role. - Based in a major Indian metropolitan location such as Mumbai, Delhi, Hyderabad, Bengaluru, or Pune. - Proven clinical monitoring capabilities and a strong understanding of medical or therapeutic terminology. - Working knowledge of ICH-GCP requirements, applicable regulations, and clinical research procedures. - Strong critical-thinking and problem-solving abilities, including experience with root-cause analysis and risk-based monitoring concepts. - Strong organizational and time-management skills, with close attention to detail. - Effective interpersonal, written, oral, and presentation skills, including the ability to communicate confidently with medical personnel and study stakeholders. - Strong customer focus, listening skills, and the ability to identify and address underlying site or stakeholder concerns. - Ability to remain flexible and adaptable across changing study requirements and environments.