Cra Ii

3+ years

Not Disclosed

India

10 Nov. 29, 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

Clinical Research Associate II

Company: Syneos Health
Location: Mumbai, Delhi, Bengaluru, Hyderabad, Ahmedabad (Preferred)

About Syneos Health

Syneos Health is a leading, fully integrated biopharmaceutical solutions organization focused on accelerating the development and delivery of therapies. With a commitment to customer success, Syneos Health brings together clinical, medical affairs, and commercial insights to achieve tangible outcomes.

"Work Here Matters Everywhere"

Why Syneos Health?

Syneos Health is passionate about people development, offering career progression, mentorship, and technical training. We value diversity, creating a workplace where everyone can authentically be themselves. By fostering an inclusive culture, we provide the resources needed to build the company we want to work for and that our customers value.

Role Overview

As a Clinical Research Associate II, you will be responsible for site management, monitoring, and ensuring that clinical trials are conducted in compliance with regulatory standards and protocols. Your role will involve performing site visits (both on-site and remotely), handling data accuracy, ensuring the integrity of clinical trials, and supporting site recruitment and retention.

Key Responsibilities

Site Monitoring & Management:
- Perform site qualification, site initiation, interim monitoring, and close-out visits to ensure compliance with regulatory standards (GCP/ICH) and study protocols.
- Use judgment to evaluate site performance, escalating issues to the project team when necessary, and developing action plans.
- Ensure informed consent is properly obtained and documented, safeguarding subject confidentiality and safety.
Clinical Data Management:
- Review source documents and medical records, ensuring the accuracy and completeness of clinical data entered into case report forms (CRFs).
- Resolve data queries remotely and on-site, ensuring timely closure within project timelines.
- Verify compliance with electronic data capture requirements and ensure data integrity.
Investigational Product (IP) Handling:
- Conduct inventory reconciliation, and verify proper dispensing, administration, and labeling of investigational products (IP) according to the protocol.
- Monitor risks and ensure IP is handled per GCP and local regulations.
Documentation & Reporting:
- Regularly review the Investigator Site File (ISF), ensuring its accuracy and compliance with Trial Master File (TMF) requirements.
- Document activities via reports, follow-up letters, communication logs, and other project documents as per SOPs.
- Support subject/patient recruitment and retention strategies, ensuring proper documentation in tracking systems.
Site Liaison & Training:
- Act as the primary liaison with site personnel, ensuring compliance with applicable study requirements.
- Support the training of junior staff and ensure the site is audit-ready, preparing for audits and follow-up actions.
Real-World Late Phase Studies:
- Support sites throughout the study lifecycle, from identification through close-out.
- Engage in chart abstraction activities and collaborate with local affiliates and medical science liaisons.
- Suggest sites based on local treatment patterns, patient advocacy, and HCP associations.

Qualifications

Education & Experience:

Bachelor’s degree or RN in a related field, or equivalent combination of education and experience.
Minimum 3 years of experience in onsite and remote monitoring.
Neurology, immunology, rare diseases, cardiovascular disease (CVD), and oncology therapeutic area experience preferred.
Strong understanding of Good Clinical Practice (GCP), ICH Guidelines, and applicable regulatory requirements.

Technical Skills & Knowledge:

Ability to effectively use clinical trial management systems and new technologies.
Knowledge of clinical data management and good familiarity with clinical trial processes.
Ability to quickly adapt to changing priorities to meet project goals.

Communication & Soft Skills:

Excellent communication, presentation, and interpersonal skills.
Strong organizational skills and attention to detail.
Ability to manage required travel (up to 75%) and work efficiently in a fast-paced environment.

Why Work with Us?

Career Growth: Access to development programs and career advancement opportunities.
Collaborative Environment: Work with a team passionate about accelerating therapy delivery.
Inclusive Culture: Thrive in a diverse and supportive workplace.
Comprehensive Benefits: Competitive salary, health benefits, 401k, and more.

Apply Now to become part of Syneos Health, contributing to the future of clinical research and improving lives worldwide.

Syneos Health encourages all applicants, regardless of background, to apply. We also offer an opportunity to join our Talent Network to stay updated on future roles and opportunities.

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