CRA 2 – Clinical Research Associate
Company: IQVIA
Location: Thane, India
Employment Type: Full-Time
Work Arrangement: Hybrid
Job ID: R1564899
Function: Clinical Research / Clinical Operations
Position Overview
The CRA 2 is responsible for conducting clinical trial monitoring and site management activities to ensure that assigned clinical trial sites operate in accordance with study protocols, applicable regulations, Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and sponsor requirements.
The role involves regular interaction with clinical trial sites, monitoring study progress, supporting patient recruitment, reviewing site quality, managing study documentation, and ensuring timely resolution of site-related issues.
Key Responsibilities
Site Monitoring
Conduct Site Selection Visits (SSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV).
Perform monitoring activities according to the contracted scope of work and applicable regulatory requirements.
Ensure sites conduct clinical trials according to the approved protocol.
Evaluate the quality and integrity of site practices.
Verify compliance with GCP, ICH guidelines, local regulations, and sponsor requirements.
Identify and escalate quality or compliance issues appropriately.
Site Management
Establish and maintain effective communication with assigned clinical trial sites.
Manage ongoing site expectations, concerns, and operational issues.
Provide protocol and study-related training to site personnel.
Maintain regular communication with investigators and site teams.
Support site start-up activities when required.
Build and maintain effective relationships with investigators, site staff, study teams, managers, and clients.
Patient Recruitment and Enrollment
Work with clinical trial sites to implement and monitor subject recruitment plans.
Track recruitment and enrollment against project targets.
Identify recruitment challenges and work with sites to develop appropriate solutions.
Support development of site-specific recruitment strategies when applicable.
Monitor recruitment progress and communicate risks or delays to the study team.
Study Progress Management
Track the overall progress of assigned clinical studies.
Monitor regulatory submissions and approvals.
Track patient recruitment and enrollment.
Monitor Case Report Form (CRF) completion and submission.
Track data query generation and resolution.
Identify potential delays or risks affecting study timelines.
Provide regular updates to the study team.
Clinical Trial Documentation
Ensure required site documents are collected and available for filing in the Trial Master File (TMF).
Verify that the Investigator Site File (ISF) is maintained appropriately.
Ensure documentation complies with GCP and local regulatory requirements.
Prepare and maintain monitoring visit documentation.
Document monitoring findings and required corrective or follow-up actions.
Prepare and submit regular monitoring visit reports.
Generate follow-up letters and other required study documentation.
Maintain appropriate documentation of site management activities and action plans.
Quality and Compliance
Ensure clinical trial activities are conducted in accordance with:
Study protocol
Good Clinical Practice (GCP)
ICH guidelines
Local regulatory requirements
Sponsor requirements
Applicable SOPs
Identify potential compliance issues and escalate them appropriately.
Support quality and inspection readiness activities.
Ensure appropriate follow-up and resolution of site findings.
Study Team Collaboration
Collaborate with Clinical Trial Managers and other study team members to support successful project execution.
Communicate site performance, risks, issues, and monitoring findings.
Participate in study-related meetings and discussions.
Provide operational support throughout the clinical trial lifecycle.
Work closely with sites and internal teams to resolve study-related issues.
Financial Management
Where applicable:
Support site financial management activities.
Ensure payments are handled according to the executed Clinical Trial Agreement.
Retrieve and process site invoices according to local requirements.
Monitor financial activities associated with assigned sites.
Required Qualifications and Experience
Bachelor's degree in a scientific or healthcare-related discipline preferred.
Minimum 1 year of on-site clinical monitoring experience required.
Equivalent combinations of education, training, and relevant experience may be considered.
Prior CRA experience is strongly relevant.
Regulatory and Clinical Knowledge
Good understanding of Good Clinical Practice (GCP).
Knowledge of International Conference on Harmonization (ICH) guidelines.
Understanding of applicable clinical research regulations.
Good therapeutic area knowledge.
Ability to understand and apply clinical trial protocols.
Understanding of clinical trial site management and monitoring processes.
Technical Skills
Proficiency in Microsoft Word.
Proficiency in Microsoft Excel.
Proficiency in Microsoft PowerPoint.
Ability to effectively use laptops and applicable mobile devices such as iPhone and iPad.
Ability to work with clinical trial systems and study documentation.
Professional Skills
Strong written and verbal communication skills.
Good command of English.
Strong organizational skills.
Strong problem-solving abilities.
Effective time-management skills.
Ability to manage site-related financial activities when required.
Strong attention to detail.
Ability to work independently and as part of a global study team.
Ability to establish and maintain effective relationships with colleagues, managers, investigators, site personnel, and clients.
Ideal Candidate Profile
The ideal candidate is a clinical research professional with at least one year of on-site monitoring experience and a strong understanding of GCP, ICH guidelines, clinical trial protocols, and site management.
The candidate should be comfortable working directly with investigators and site teams, conducting monitoring visits, tracking recruitment and study milestones, reviewing clinical documentation, identifying compliance issues, and maintaining high-quality study records.
Strong communication, organization, problem-solving, and time-management skills are essential for success in this role.
About IQVIA
IQVIA is a global provider of clinical research services, healthcare intelligence, and commercial insights serving the life sciences and healthcare industries.
The organization supports the development and commercialization of innovative medical treatments with the goal of improving patient outcomes and population health.
Recruitment Integrity
IQVIA maintains a zero-tolerance policy for candidate fraud. All information, qualifications, credentials, and documentation submitted during the recruitment process must be truthful and complete.
False statements, misrepresentations, or material omissions may result in disqualification from the recruitment process or termination of employment if discovered after hiring.
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