CRA (Level II)

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.

• Ability to work effectively both independently and as part of a multidisciplinary project team.

• Solid computer skills, including Microsoft Office proficiency and the ability to learn relevant clinical systems and software.

• Good English-language and grammar skills.

• Willingness and ability to travel frequently, generally around 60–80%, including potential overnight stays.

• Comfortable working in environments that may involve exposure to clinical sites, biological fluids, infectious organisms, protective equipment, and varying environmental conditions.

Benefits

• Full-time position with a standard Monday–Friday work schedule.

• Opportunity to contribute to clinical research and support the delivery of pharmaceutical and biotechnology studies.

• Exposure to international clinical trial projects, investigative sites, and multidisciplinary teams.

• Combination of remote and on-site clinical monitoring activities.

• Professional development through hands-on experience with clinical monitoring, risk-based approaches, regulatory requirements, and study management.

• Opportunity to contribute to process improvement initiatives and broader project work.

• Work environment designed to support collaboration, learning, and development within a global clinical research organization.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether?

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

#LI-CL1