Senior Cra

2+ years

Not Disclosed

10 March 3, 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
Job ID: 24006813

Description:

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success. Our Clinical Development model places the customer and the patient at the center of our work, ensuring streamlined operations and efficient service.

Job Responsibilities:

Perform site qualification, initiation, interim monitoring, site management, and close-out visits, ensuring compliance with regulations, ICH-GCP, and protocols.
Evaluate site performance and escalate serious issues to the project team, developing action plans as needed.
Ensure informed consent processes are properly documented for each subject/patient.
Assess factors affecting patient safety and clinical data integrity.
Conduct source document reviews, verify clinical data accuracy, and ensure electronic data capture compliance.
Manage investigational product (IP) inventory, storage, and administration according to protocols.
Maintain Investigator Site File (ISF) and reconcile with the Trial Master File (TMF).
Document site activities via reports, letters, logs, and tracking systems.
Support patient recruitment, retention, and awareness strategies.
Monitor project scope, budget, and timelines to ensure objectives are met.
Act as a primary liaison with project site personnel, ensuring compliance with training requirements.
Attend Investigator Meetings and sponsor face-to-face meetings.
Provide guidance and support in audit readiness preparations.
Offer mentorship and training to junior CRAs as needed.
For Real World Late Phase (RWLP) studies:
- Support sites from identification through close-out.
- Conduct chart abstraction and data collection.
- Collaborate with sponsors, medical science liaisons, and affiliates.
- Develop country-specific informed consent forms.

Qualifications:

Bachelor’s degree or RN in a related field or equivalent combination of education and experience.
Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements.
Proficiency in computer skills and adaptability to new technologies.
Strong communication, presentation, and interpersonal skills.
Critical thinking and problem-solving abilities.
Ability to manage up to 75% travel.

About Syneos Health:

With experience in 94% of FDA-approved drugs and 95% of EMA-authorized products over the past five years, Syneos Health continues to lead clinical research across 73,000 sites and over 675,000 trial patients.

Note: Responsibilities and qualifications are subject to change. Equivalent experience and skills may be considered. Syneos Health complies with global regulatory requirements, including the EU Equality Directive and the Americans with Disabilities Act.

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Senior Cra

Job Description

Description:

Job Responsibilities:

Qualifications:

About Syneos Health:

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