Sr. CRA1 Professional

IQVIA Biotech; Thane; On-site; INR 800,000 - 1,500,000; Full time

Job summary

IQVIA Biotech is seeking a Site Monitoring Specialist to ensure sites conduct studies per protocol and adhere to required regulations. You will perform monitoring visits, support subject recruitment plans, and train site staff.

You will evaluate site practices for quality and regulatory compliance, manage regulatory submissions, and maintain study documents. Strong communication and organizational skills are essential.

Qualifications

• Bachelor's degree in a scientific discipline or health care preferred.
• Requires at least 2 years of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Good knowledge of applicable clinical research regulatory requirements (GCP/ICH).
• Proficiency in Microsoft Word, Excel and PowerPoint; use of laptop and mobile devices.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope of work and GCP.
• Collaborate with sites to manage subject recruitment plan to align with project needs.
• Administer study protocol training and maintain regular communication with sites.
• Evaluate site practices for protocol conduct and regulatory adherence.
• Track regulatory submissions, recruitment, CRF completion, data queries and resolution.
• Maintain TMF/ISF documentation per regulatory requirements.
• Create and maintain site management documentation and visit reports.
• Coordinate with study team for project execution support.
• May support startup or site financial management as applicable.

Skills

GCP/ICH knowledge

Regulatory compliance

English communication

Time management

Relationship building

Education

Bachelor's degree in scientific discipline or health care

Experience accepted in lieu of degree

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Laptop computer

iPhone/iPad

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.