Sr. CRA1 Professional

IQVIA Biotech; Dadri; On-site; INR 600,000 - 1,200,000; Full time

Job summary

IQVIA Biotech is seeking an experienced Site Monitoring professional in India to ensure sites conduct studies per protocol and comply with GCP, ICH, and sponsor requirements. You will support site selection, initiation, monitoring, close-out visits, and drive subject recruitment plans to enhance study predictability.

The role requires 2+ years of on-site monitoring experience, familiarity with regulatory requirements, and strong English communication.

Qualifications

• Requires 2+ years of on-site monitoring experience.
• Knowledge of GCP and ICH guidelines is essential.
• Good knowledge of regulatory requirements and clinical research processes.
• Strong written and verbal English communication.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope of work and GCP.
• Coordinate subject recruitment plans to support project needs and predictability.
• Provide protocol training and maintain regular communication with sites.
• Evaluate site practices for protocol compliance and regulatory adherence.
• Track regulatory submissions, enrolment, CRF completion, and data queries.

Skills

On-site monitoring

Project coordination

Time management

Communication skills

Problem solving

English proficiency

Education

Bachelor's degree in scientific discipline

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Job Summary

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigators Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications

• Bachelors Degree Scientific discipline or health care preferred. Req
• Requires at least 2 years of on-site monitoring experience. Req
• Equivalent combination of education, training and experience may be accepted in lieu of degree. Req
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
• i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.