Sr Cra I (Home-Base, Malaysia)

6+ years

Not Disclosed

Remote

10 Jan. 16, 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 I (Home-based, Malaysia)

Updated: January 14, 2025
Location: Malaysia (Home-Based)
Job ID: 25001000

Position Overview

Syneos Health® is a global leader in the biopharmaceutical industry, offering endless opportunities for professional growth. As a Senior CRA I, you will help us improve patients' lives worldwide by ensuring clinical studies are conducted with the highest standards. At Syneos Health, work matters everywhere.

#SyneosHealthLife
Our Total Self culture unites us globally, celebrating each person’s unique contributions. We focus on taking care of you so you can care for others.

Why Join Syneos Health?

Total Self Culture: Be your authentic self in a supportive environment.
Employee Wellbeing: Comprehensive benefits program encompassing physical, mental, and financial health.
Global Collaboration: Work with experts from diverse backgrounds, sharing insights to foster innovation and create a place where everyone feels like they belong.

Key Responsibilities

Clinical Site Management
- Perform site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remotely), ensuring compliance with regulatory standards and protocols.
- Ensure informed consent is appropriately obtained and documented for each subject/patient.
- Evaluate site performance, address issues, and develop action plans as needed.
Monitoring and Compliance
- Conduct source document reviews and ensure data accuracy in Case Report Forms (CRFs).
- Drive query resolution and ensure timely closure of queries.
- Oversee the investigational product (IP) inventory, reconciliation, and ensure proper storage and dispensing.
Documentation and Reporting
- Review Investigator Site Files (ISFs) for completeness and accuracy.
- Document all activities, including confirmation letters, trip reports, and communication logs.
Training and Mentorship
- Provide training and mentorship to junior-level CRAs.
- Lead or assist in clinical operations tasks under the supervision of a Clinical Operations Lead (COL).
Real-World Late Phase (RWLP) Support (if applicable)
- Assist with site support, chart abstraction, and data collection throughout the study lifecycle.
- Build relationships with sponsors, affiliates, and medical science liaisons.

Qualifications

Education: Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
Experience:
- Demonstrated knowledge of Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements.
- Prior experience in clinical research is preferred.
Skills:
- Strong computer skills and ability to adapt to new technologies.
- Excellent communication, presentation, and interpersonal skills.
Travel: Ability to travel up to 75% as required.

Why Syneos Health is a Great Choice

Syneos Health is the only full-service biopharmaceutical solutions company, bringing together clinical and commercial expertise to get medicines into the hands of patients faster.

Additional Information

This job description may evolve as business needs change. Syneos Health is committed to providing reasonable accommodations as needed to assist employees or applicants to perform the essential functions of the role.

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