CRA (Level II)

Lever, Inc.; India; Hybrid; INR 900,000 - 1,300,000; Full time

Benefits offered by this job

Full-time position

Remote/on-site mix

International project exposure

Travel opportunities

Job summary

Lever, Inc. in India is seeking a CRA (Level II) based in India to support clinical trials. You will coordinate monitoring and site management across studies, combining remote and on-site activities while collaborating with clinical, client, and project teams.

The role applies risk-based monitoring, root-cause analysis, and ensures data quality and compliance with ICH-GCP and regulatory requirements. Travel will be frequent, and you will contribute to study documentation, audits readiness, and

Qualifications

• Bachelor's degree in life sciences or nursing or equivalent qualification.
• Minimum 2 years of on-site clinical monitoring experience.
• Based in a major Indian metropolitan location (e.g., Mumbai, Delhi, Hyderabad, Bengaluru, Pune).
• Solid understanding of ICH-GCP, regulatory requirements, and clinical procedures.

Responsibilities

• Conduct remote and on-site monitoring visits using risk-based monitoring to assess protocol compliance and data quality.
• Perform source data review, CRF review, and essential document checks as required.
• Identify site deficiencies and risks; propose corrective actions and follow through to resolution.
• Maintain regular communication with investigative sites to support protocol adherence and data entry.
• Initiate trial sites, support investigator identification and meetings, and contribute to close-outs.
• Ensure essential documents are complete and maintained per ICH-GCP.
• Provide study status updates and maintain trial management system records.
• Foster effective communication among sites, project teams, and clients.

Skills

On-site monitoring

Remote monitoring

Risk-based monitoring

Root-cause analysis

ICH-GCP knowledge

Travel 60-80%

Communication skills

Time management

Clinical data review

Microsoft Office

Study documentation

Independent worker

Education

Bachelor's degree in life sciences or nursing

Tools

Microsoft Office

Clinical trial management systems

Job description

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.

• 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.