Remote Sr. Clinical Research Associate Job Vacancies at Parexel

Parexel Senior Clinical Research Associate Job Vacancies

Introduction: Parexel, a renowned name in clinical research, is seeking qualified candidates for the position of Senior Clinical Research Associate (CRA) in India, offering remote work options. Dive into this article to discover exciting opportunities, detailed job responsibilities, and insights into joining the esteemed Parexel team.

Company Vacancies List:

• Position Title: Senior Clinical Research Associate
• Company Name: Parexel
• Salary: Competitive, commensurate with experience

Job Description: Embark on a rewarding journey as a Senior Clinical Research Associate at Parexel, contributing to the global efforts of getting treatments to patients sooner. This role entails diverse responsibilities, ensuring the safety and well-being of patients. As a CRA, you will travel to investigator sites, build relationships, and act with integrity, playing a vital role in clinical trials.

Key Accountabilities:

Start-up (from site identification through pre-initiation):

• Serve as Parexel’s direct point of contact with assigned sites.
• Build and manage relationships with investigators and site staff.
• Conduct country-specific feasibility and site pre-qualification/qualification activities.
• Prepare and negotiate Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs), and amendments.
• Conduct remote Qualification Visits (QVs).
• Generate visit/contact reports and address site issues with effective problem-solving.
• Develop strategies for IRB/IEC and MoH/RA submissions, site activation, and patient recruitment.
• Update and maintain Clinical Trial Management systems (CTMS) and ensure compliance with project-specific training.

Maintenance (from initiation through closeout):

• Assess overall study implementation and adherence to protocols at clinical sites.
• Facilitate site access to study systems and ensure compliance with training requirements.
• Evaluate and implement corrective actions for on-site staff assignments.
• Address and resolve site issues, including deficiencies in documentation and communication.
• Follow up on site-related questions, data quality, and data integrity issues.
• Actively participate in Investigator meetings, audits, and regulatory inspections.
• Collect, review, and approve updated/amended site documentation.
• Assess site recruitment plans and provide improvement strategies.
• Perform on-site visits, including Qualification and Initiation visits.
• Conduct remote visits/contacts as needed.
• Evaluate site compliance, performance, and manage test article/study supply.
• Review site payment status and follow up on CRF data entry, query status, and SAEs.
• Conduct on-site study-specific training (if applicable) and site facilities assessments.

Overall Accountabilities from Site Identification to Closeout:

• Ensure timely completion of project goals and update relevant trial management systems.
• Work collaboratively with team members to meet project goals and encourage support where needed.
• Update CTMS regularly and ensure sites are audit and inspection-ready.
• Monitor and maintain compliance with ICH-GCP, international and local regulations.
• Delegate tasks to Administrative Support Team and provide guidance.
• Maintain a positive and results-oriented work environment.
• Show commitment to consistent high-quality work and communicate openly within the team.
• Keep manager informed about work progress and any issues.
• Develop expertise and provide input for Performance Development Conversations.

Skills:

• Strong problem-solving skills.
• Ability to work independently and seek guidance when necessary.
• Excellent presentation and client-focused approach.
• Flexibility and ability to prioritize multiple tasks.
• Strong decision-making ability in ambiguous situations.
• Willingness to work in a matrix environment and value teamwork.
• Strong computer skills including knowledge of CTMS, EDMS, and MS-Office.
• Excellent interpersonal, verbal, and written communication skills.
• Sense of urgency and excellent time management.
• Proven ability to work across cultures.

Knowledge and Experience:

• Substantial Site Management experience or equivalent in clinical research.
• Understanding of clinical trials methodology and terminology.

Education:

• Degree in a biological science, pharmacy, or other health-related discipline preferred, or equivalent nursing qualification or experience.

Apply online