Central Cra (Clinical Research Associate)- Registries

3+ years

Not Disclosed

Hyderabad

10 Dec. 13, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Research Associate (CRA)
Location: Not specified (potentially global or specific regions)
Job Type: Full-time

About Sanofi

Sanofi is a global leader in healthcare, making breakthroughs that improve lives through science. Our efforts are focused on better medications, outcomes, and innovations that change the future of healthcare. Join us in making miracles happen by contributing to the success of clinical research and trial monitoring, and driving positive change in the field of clinical development.

Position Overview

As a Clinical Research Associate (CRA) at Sanofi, you will play a critical role in overseeing clinical trials across sites and ensuring their adherence to regulatory standards, protocols, and ethical guidelines. You will work closely with stakeholders, including investigators, regulatory bodies, and patients, to manage and monitor clinical trial activities. This role involves managing site visits, ensuring data quality, and maintaining compliance with all aspects of the clinical trial process.

Main Responsibilities

Clinical Trial Management & Monitoring:

Site Visits & Monitoring: Conduct and follow-up on site visits, including Site Selection, Site Initiation, Routine Monitoring (Remote / On-site), and Close-Out Visits. Ensure that trial procedures adhere to Study Manual, Protocol, Local Regulations, Good Clinical Practice (GCP), and SOPs.
Data Quality Control: Perform source document verification and review eCRF completeness to ensure accurate data reporting. Resolve data queries from sites and escalate issues when necessary.
Safety & Compliance Reporting: Ensure the site adheres to safety reporting processes, submitting safety information to the EC/IRB/RA in accordance with local regulations and SOPs.
Issue Management & CAPA: Perform root cause analysis of trial deviations, implement corrective and preventive actions (CAPA), and ensure sites are audit-ready.
Database & Documentation: Maintain updated tables, trackers, and databases to follow study progress both locally and globally. Contribute to the eTMF process and ensure timely collection of required site documents.

Stakeholder Engagement & Communication:

Identify Key Stakeholders: Work with sponsors, investigators, regulatory bodies, and patients, understanding their roles and impact on the clinical trial process.
Effective Communication: Regularly update stakeholders on trial progress, issues, and outcomes, using clear and timely communication.
Relationship Building: Develop and maintain positive relationships with stakeholders, addressing their concerns and aligning their expectations with trial objectives.
Conflict Resolution & Ethics: Mediate conflicts and ensure ethical conduct in trial processes, adhering to regulatory guidelines.

Project Management & Technical Expertise:

Trial Progress Tracking: Oversee and manage multiple aspects of the trial, ensuring that the study is on schedule and within budget.
Global Projects Management: Coordinate international data collection projects and manage trials within a global, matrix environment.
Reporting & Documentation: Prepare detailed reports, regulatory documents, and trial progress summaries as required.

Experience & Skills

Experience:
- Minimum of 3+ years experience in clinical research and development, with clinical trial monitoring experience.
- Experience in rare diseases or observational studies or real-world evidence would be a plus.
- Strong attention to detail and ability to identify and resolve trial issues efficiently.
- Project management experience, including managing timelines, resources, and budgets.
- Proficiency in technical writing for reports, protocols, and regulatory documents.
- Experience working in global projects and managing clinical trials across multiple countries.
Soft Skills:
- Excellent communication skills, both written and oral, for interacting with various stakeholders.
- Ability to adapt to evolving trial requirements and environments.
- Strong interpersonal skills for building relationships with stakeholders.
- Excellent time management and task prioritization abilities.
- A strong ethical judgment and integrity in handling clinical trials and research.
Technical Skills:
- Proficiency in Good Clinical Practice (GCP) and understanding of regulatory requirements (FDA, EMA, etc.).
- Knowledge of clinical trial phases, protocols, and methodologies.
- Strong skills in data management and medical terminology.
- Proficient in using Microsoft Office products.
Education:
- Degree in a pharma/scientific discipline or related Life Science field.
Languages:
- High proficiency in both written and spoken English.

Why Choose Us?

At Sanofi, we recognize that our people are the key to driving progress and creating extraordinary outcomes in healthcare. We offer a dynamic and supportive work environment, with opportunities for career growth and development. Our benefits include a comprehensive rewards package, health and wellness programs, and strong support for work-life balance.

Pursue Progress. Discover Extraordinary.
If you’re passionate about clinical research and want to make a meaningful impact in global healthcare, this is your opportunity to join a team of innovators and change-makers.

Equal Opportunity Employer
Sanofi celebrates diversity and provides equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

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