Cra I

5+ years

Preffered by Company

Mumbai

10 Sept. 3, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience 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

Position: Clinical Research Associate I
Location: Mumbai

Company Overview:

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating our customers' success. By leveraging unique clinical, medical affairs, and commercial insights, we address modern market challenges and focus on simplifying and streamlining our work. Our Clinical Development model places the customer and patient at the center of everything we do, driving us to innovate and collaborate to achieve success.

Why Syneos Health?

At Syneos Health, we are committed to developing our people through career growth opportunities, supportive management, and comprehensive training. Our Total Self culture encourages authenticity and inclusivity, ensuring that every employee feels valued and engaged. We strive to create a workplace where diversity of thought and background fosters belonging and drives excellence.

Job Responsibilities:

Site Management: Perform site qualification, initiation, interim monitoring, management, and close-out visits, either on-site or remotely. Ensure compliance with regulatory standards (ICH-GCP, Good Pharmacoepidemiological Practices, and protocols). Evaluate site performance and communicate serious issues to the project team, developing action plans as needed.
Data Review and Documentation: Verify informed consent processes, ensure confidentiality, and assess factors affecting patient safety and data integrity. Conduct source document reviews, verify clinical data accuracy in CRFs, and resolve queries. Ensure compliance with electronic data capture requirements and manage investigational product (IP) inventory and documentation.
Project Coordination: Review Investigator Site Files (ISF), reconcile with the Trial Master File (TMF), and ensure proper archiving of essential documents. Track project scope, budgets, and timelines, managing site-level activities to meet objectives. Act as a liaison with site personnel and ensure site compliance with project requirements.
Training and Meetings: Provide training to site and project-specific team members. Prepare for and attend Investigator Meetings, sponsor face-to-face meetings, and global clinical monitoring/project staff meetings. Support audit readiness and preparation for audits.

For Real World Late Phase Studies:

Use the title Site Management Associate I and handle site support throughout the study lifecycle. Understand local requirements for late phase studies and perform chart abstraction and data collection.

Qualifications:

Educational Background: Bachelor’s degree or RN in a related field, or an equivalent combination of education, training, and experience.
Experience and Skills: Knowledge of Good Clinical Practice/ICH Guidelines and relevant regulatory requirements. Strong computer skills and adaptability to new technologies. Excellent communication, presentation, and interpersonal skills. Ability to manage travel requirements of up to 75% regularly.

Additional Information:

The duties and responsibilities outlined in this job description are not exhaustive and may be adjusted at the discretion of Syneos Health. We consider equivalent experience, skills, and education. This position does not create an employment contract and may be subject to changes as needed. Syneos Health is committed to diversity and inclusion and encourages applicants from all backgrounds to apply. We also invite you to join our Talent Network for future opportunities.

Apply Now or Join Our Talent Network to stay connected with career opportunities at Syneos Health.

Learn More About Syneos Health here.

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Cra I

Job Description

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