Parexel Clinical Research Job For Biological Sciences, Apply Online
Senior Clinical Research Associate
India-Bengaluru-Remote
Posted 5 Days Ago
Job Requisition ID: R0000007021
About Parexel
At Parexel, we all share the same goal – to improve the world’s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special – a deep conviction in what we do. We take our work personally, we do it with empathy, and we’re committed to making a difference.
Key Accountabilities:
Start-up (from site identification through pre-initiation):
- Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
- Build relationships with investigators and site staff.
- Conduct, drive and manage country-specific feasibility and/or site pre-qualification and qualification activities.
- Generate visit/contact reports, identify site issues, and direct resolution.
- Develop strategy for country-specific and/or site-specific documents and regulatory documents.
- Customize, review, and negotiate country/site-specific Informed Consent Forms (ICF) and any amendments.
- Prepare and submit IRB/IEC and MoH/RA applications and resolve conflicts regarding approval.
- Submit all pertinent documentation to the trial master file.
- Forecast, develop, manage, and revise plans and strategies for IRB/IEC and MoH/RA submission/approval, site activation, and patient recruitment & retention.
- Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
- Address and resolve site questions and issues.
- Facilitate and support allocated sites with access to relevant study systems and training requirements.
- Participate in meetings, audits, and regulatory inspections.
Maintenance (from initiation through close out):
- Assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites.
- Build relationships with investigators and site staff.
- Familiarize and support site with study systems and training requirements.
- Evaluate if on-site staff assignment is accurate and implement corrective actions.
- Address and resolve issues at sites, including the need for additional training and communication.
- Follow-up on pending issues from previous visits.
- Follow-up on and respond to site-related questions.
- Evaluate potential data quality and data integrity issues.
- Participate in meetings, audits, and regulatory inspections.
- Evaluate and approve updated/amended site documentation.
- Evaluate site recruitment plan and provide strategy for improvements.
- Perform on-site visits and generate visit/contact reports.
- Evaluate compliance and performance of sites and site staff.
- Assess and manage test article/study supply.
- Follow-up on CRF data entry, query status, and SAEs.
- Conduct on-site study-specific training.
- Perform site facilities assessments.
- Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action.
Overall Accountabilities from Site Identification to Close out:
- Ensure timely and accurate completion of project goals and update of trial management systems.
- Work with team members to meet project goals and encourage support.
- Maintain compliance with guidelines and regulations.
- Delegate administrative tasks to support team.
- Maintain a positive work environment and high-quality work.
- Maintain knowledge of guidelines, regulations, and study-specific procedures.
- Ensure high-quality, timely, and efficient delivery.
- Provide input and feedback for Performance Development Conversation(s).
- Keep manager informed about work progress and any issues.
- Develop expertise and work independently.
- Complete additional tasks in a timely manner.
Skills:
- Strong problem-solving skills
- Able to take initiative and work independently
- Excellent presentation skills
- Client-focused approach to work
- Ability to prioritize multiple tasks
- Strong ability to make decisions in ambiguous situations
- Willingness to work in a team environment
- Strong computer skills
- Excellent interpersonal, verbal, and written communication skills
- Shows commitment to high-quality work
Knowledge and Experience:
- Substantial Site Management experience or equivalent experience in clinical research
Education:
- Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent
Apply for this position here.
Keywords: Parexel, clinical research, biological sciences, Senior Clinical Research Associate, India-Bengaluru, Remote, site management, regulatory compliance, data integrity, clinical trials, training, teamwork. Parexel Clinical Research Job For Biological Sciences, Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
