Clinical Operations Assistant

3+ years

Not Disclosed

Bengaluru

10 Nov. 26, 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

Position: Clinical Operations Assistant (COA)
Location: India (Supporting Japan Projects)

Biorasi is seeking a Clinical Operations Assistant (COA) to support clinical research projects for Japan, working collaboratively with global teams and local site management. The role requires bilingual proficiency in Japanese (N2/N3) and English, as all written and verbal communications will be conducted in these languages.

Job Purpose:

The COA will maintain and manage the Central Files for Clinical Operations, ensuring accuracy, compliance, and efficiency. This includes handling electronic and paper files, supporting site management teams, and conducting administrative tasks that facilitate the successful delivery of clinical trials in Japan.

Key Responsibilities:

Document Management:

Track, scan, code, and upload documents to electronic systems as per Central File Maintenance Plans (CFMP).
Archive paper-based documents securely and ensure proper filing.
Conduct quality checks to ensure compliance with document maintenance standards.

Site and Study Support:

Support site management team members with administrative and billable tasks.
Liaise with investigative sites and sponsors to collect, review, and process required clinical trial documents.
Organize and track translations of study documents by coordinating with translation vendors.
Handle courier shipments of study documents to sites, vendors, and sponsors.

Systems and Process Monitoring:

Maintain trackers for study-specific data in the Clinical Trial Management System (CTMS).
Monitor compliance with Safety Information Systems (SIS) and other reporting obligations.

Payment and Finance Coordination:

Process invoices and payments, working closely with the finance team to ensure timely follow-ups.
Assist in gathering signatures for site documents like confidentiality agreements or site contracts.

Communication and Collaboration:

Serve as a liaison between project teams, sites, and sponsors.
Maintain clear and professional communication with all stakeholders in Japanese and English.
Assist in meeting project timelines and deliverables by coordinating with cross-functional teams.

Key Skills and Competencies:

Language Proficiency: Japanese (N2/N3 level) and fluent English (written and verbal).
Clinical Research Knowledge: Understanding of clinical trial methodologies, site management, and documentation processes.
Problem-Solving Skills: Ability to address issues autonomously and prioritize tasks effectively.
Interpersonal Skills: Strong communication skills to interact professionally with investigators, sites, and sponsors.
Time Management: Efficiently manage multiple tasks and maintain attention to detail under tight deadlines.
Technical Proficiency: Experience with CTMS and electronic document systems is preferred.

Qualifications and Experience:

Bachelor’s degree in a health-related discipline (biological sciences, pharmacy, etc.) or equivalent nursing qualification.
Site Management or relevant clinical research experience.
Prior experience in the CRO or life sciences industry is preferred.

Why Join Us?

Work on groundbreaking clinical trials with a dynamic, innovative team.
Contribute to advancing healthcare solutions globally.
Enjoy opportunities for professional growth and development in a supportive work environment.

If you’re a motivated, detail-oriented professional with the required skills and experience, apply now at Biorasi.com or send your resume to careers@biorasi.com.

Biorasi is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive workplace.

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Clinical Operations Assistant

Job Description

Job Purpose:

Key Responsibilities:

Document Management:

Site and Study Support:

Systems and Process Monitoring:

Payment and Finance Coordination:

Communication and Collaboration:

Key Skills and Competencies:

Qualifications and Experience:

Why Join Us?

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