Clinical Research Associate_Pms

2+ years

Not Disclosed

Remote Korea

10 Dec. 5, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Title: Clinical Research Associate (CRA) – PMS (1+ year experience)
Location: Hybrid (Flexible working hours)
Company: Novotech

About Us:
Novotech is a leading Asia-Pacific biotech specialist Contract Research Organization (CRO) with offices across 11 geographies. We provide comprehensive clinical development services, including feasibility assessments, regulatory submissions, data management, medical monitoring, and project management. With over 3,700 clinical projects completed, Novotech is committed to serving biopharmaceutical clients conducting trials globally. The company is ISO 27001 and ISO 9001 certified, ensuring the highest IT security and quality standards for patients and biotechnology companies.

Position Overview:
The Clinical Research Associate (CRA) is primarily responsible for ensuring the rights and well-being of clinical trial participants while ensuring the accuracy and completeness of trial data. The CRA acts as the key contact between Investigational Sites, Novotech, and Sponsors, ensuring clinical trials are conducted according to ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.

Responsibilities:

Build strong relationships with Principal Investigators, study coordinators, pharmacists, and site personnel to ensure efficient management of clinical trials.
Work with the IHCRA or DMA team to ensure the Trial Master File (TMF) is current and complete throughout the study.
Monitor investigational sites in line with ICH GCP §5.18 (Monitoring) and the Clinical Monitoring Plan (CMP). This includes all types of monitoring visits such as Site Selection, Initiation, Monitoring, Close Out, unblinded pharmacy visits, and co-monitoring visits.
Complete specialized CRA II training, including observational visits and on-the-job training, supporting day-to-day CRA activities.
Provide written and verbal updates on study progress to the PM/LCRA, following study requirements/timelines, and escalate issues according to the Issue Escalation SOP.

Minimum Qualifications & Experience:

Minimum of 1 year of independent clinical monitoring experience.
Graduate in clinical or life sciences-related fields (relevant experience/qualifications in allied professions will be considered).
Strong time management skills, attention to detail, teamwork abilities, and computer literacy.

What We Offer:

Hybrid work environment with flexible working hours.
An inclusive, diverse workplace committed to gender equality and employee well-being.
Paid parental leave for both parents, flexible leave entitlements, wellness programs, and ongoing professional development opportunities.
We encourage applications from all individuals, including those identifying as LGBTIQ+, individuals with disabilities, and those with caring responsibilities.

Why Novotech:
Novotech provides a collaborative work environment where clinical research and biotech professionals can thrive. Our culture prioritizes flexibility, work-life balance, and the development of our team members.

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