Senior Clinical Research Associate Contractor

Biorasi

2+ years

Not Disclosed

Remote, USA

10 Dec. 11, 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)
Location: Remote / On-Site
Employment Type: Full-time
Posted: 12/11/2024

About Biorasi:

At Biorasi, we are growing and dedicated to supporting your career journey in an innovative, collaborative, dynamic, and evolving environment. We capitalize on your strengths while promoting a healthy work-life balance. As an award-winning, customer-focused, full-service clinical research organization, we help drive new therapies to patients. Join our growing global team and become a part of the expanding clinical research industry.

Your Role:

As a Clinical Research Associate (CRA), you will play a pivotal role in managing and monitoring clinical trial activities across sites. Your responsibilities include:

Site Visits: Plan, schedule, and conduct Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits, and Site Close-out Visits.
Report Writing: Write detailed reports and Investigator Follow-up Letters for all site visits.
Study Progress: Track study progress including regulatory/IRB submissions, recruitment, CRF completion, data queries, and resolution.
Project Updates: Provide project updates to the project management team on recruitment, enrollment, and site activities.
Material Delivery & Inventory: Organize delivery and return of investigational products, lab supplies, and study materials. Perform investigational product inventory checks.
Training & Communication: Assist with Investigator Meetings, conduct training for study sites, and establish effective communication with sites.
Document Management: Review and collect essential study documents for the eTMF and ensure compliance with protocol and GCP guidelines.
Compliance: Adhere to international GCP regulations and SOPs. Participate in quality assurance activities and resolve audit findings.
Resource Allocation & Support: Support the Clinical Trial Manager by reviewing site performance, providing feedback to CRAs, and assisting with the resolution of site issues.
Mentoring: Provide mentorship to associates on job performance, training, and professional growth.

Your Profile:

Education: Bachelor’s Degree in biomedical sciences or related scientific discipline.
Experience: Minimum of 3 years of monitoring experience, preferably with a combination of clinical research coordination or other relevant clinical research experience.
Skills:
- Sound knowledge of medical terminology and clinical monitoring processes.
- Ability to travel up to 70%, depending on project needs.
- Proficient in ICH GCP and worldwide regulatory requirements.
- Strong leadership, planning, project management, verbal, and written communication skills.
- Proficient in MS Office suite (Word, PowerPoint, and Excel).
Languages: Fluent in English (oral and written) and applicable local business language.

Why Biorasi?

Employee Benefits: Thoughtfully designed benefits to enhance your health and well-being.
Diversity and Inclusion: Biorasi is committed to fostering a diverse and inclusive environment and is an equal opportunity employer.

Apply Now:

If you're ready to join an energetic, creative, and collaborative team, apply directly on our website at Biorasi Careers or email us at careers@biorasi.com.

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Senior Clinical Research Associate Contractor

Job Description

About Biorasi:

Your Role:

Your Profile:

Why Biorasi?

Apply Now:

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