Senior Cra

2+ years

Not Disclosed

India

10 March 9, 2025

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

Senior Clinical Research Associate

Updated: February 28, 2025
Location: India-Asia Pacific - IND-Home-Based, India
Job ID: 24006813

Company Overview:

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Our Clinical Development model places the customer and patient at the center of everything we do. We continuously simplify and streamline our processes to enhance collaboration and efficiency.

Why Syneos Health?

Career development and progression opportunities.
Supportive and engaged line management.
Technical and therapeutic area training.
Peer recognition and total rewards program.
Commitment to diversity, inclusion, and authenticity.
A dynamic workplace focused on innovation and impact.

Job Responsibilities:

Conducts site qualification, initiation, interim monitoring, site management, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
Evaluates site and staff performance, escalates serious issues, and develops action plans.
Ensures proper informed consent processes and confidentiality protection.
Assesses site compliance with protocol requirements and patient safety.
Conducts Source Document Review and verifies accuracy of clinical data.
Resolves queries and ensures compliance with electronic data capture requirements.
Manages investigational product (IP) inventory, reconciliation, and security.
Reviews Investigator Site File (ISF) accuracy and ensures regulatory archiving compliance.
Documents activities via letters, trip reports, and communication logs.
Tracks site-level activities to meet project objectives and timelines.
Serves as a primary liaison with site personnel, ensuring training compliance.
Prepares for and attends Investigator Meetings and sponsor meetings.
Supports audit readiness and compliance actions.
Provides mentorship to junior CRAs and may assist in training.
May assist in Clinical Operations Lead tasks under supervision.
Additional Real World Late Phase (RWLP) responsibilities include:
- Site support from identification to close-out.
- Chart abstraction and data collection.
- Collaboration with sponsors and local affiliates.
- Identification of operational efficiencies and process improvements.

Qualifications:

Bachelor's degree or RN in a related field, or equivalent experience.
Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and regulatory requirements.
Strong computer skills and ability to adopt new technologies.
Excellent communication, presentation, and interpersonal skills.
Critical thinking abilities.
Ability to manage up to 75% travel regularly.

About Syneos Health:

Over the past five years, Syneos Health has collaborated on:

94% of all Novel FDA Approved Drugs.
95% of EMA Authorized Products.
Over 200 Studies across 73,000 Sites and 675,000+ Trial Patients.

Syneos Health fosters a competitive and evolving environment where employees take the initiative and challenge the status quo. Learn more about Syneos Health and become a part of a transformative team.

Additional Information:

Responsibilities outlined in this job description are not exhaustive.
The company may assign additional tasks, duties, and responsibilities as needed.
Equivalent skills, experience, and education will be considered.
The company complies with all applicable employment laws and the Americans with Disabilities Act.

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Senior Cra

Job Description

Company Overview:

Why Syneos Health?

Job Responsibilities:

Qualifications:

About Syneos Health:

Additional Information:

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