Sr CRA1

IQVIA; Bengaluru; On-site; INR 600,000 - 1,000,000; Full time

Job summary

IQVIA Bengaluru, India is seeking a Clinical Monitoring Associate to ensure sites conduct studies per protocol and regulations. You will perform monitoring visits, train site staff, and manage regulatory documents across multiple studies.

The role requires 2+ years on-site monitoring, strong GCP/ICH knowledge, and excellent English communication. Proficiency with MS Office and device usage is expected, with the ability to handle complex timelines.

Qualifications

• Bachelor's degree in a scientific discipline or health care.
• At least 2 years of on-site monitoring experience.
• Good knowledge of GCP and ICH guidelines.
• Proficient with MS Word, Excel and PowerPoint; comfortable with laptop and mobile devices.
• Strong written and verbal English communications.
• Ability to manage multiple studies and deadlines.

Responsibilities

• Conduct site monitoring visits per contracted scope and GCP.
• Coordinate subject recruitment and data submission to enhance study predictability.
• Administer protocol training to sites and maintain communication with stakeholders.
• Evaluate site practices for protocol adherence and regulatory compliance.
• Track regulatory submissions, enrollments, CRF completion, and data queries.

Skills

Site Monitoring

GCP/ICH

Regulatory Knowledge

Communication

Time Management

Education

Bachelor's Degree (Scientific/Health Care)

Tools

MS Word

MS Excel

MS PowerPoint

Job description

Job Description:

Job Overview

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.

Essential Functions

• 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 Investigator's 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

• Bachelor's 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.