Clinical Research Associate Ii Or Senior - Oncology Required

2+ years

Not Disclosed

Remote, USA

10 Nov. 6, 2024

Job Description

Job Type: Full Time Remote 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

About the Role:

KCR is seeking an experienced Clinical Research Associate II or Senior Clinical Research Associate (SCRA) with Oncology experience to join our fast-growing, global team. This home-based position is ideal for those based in the Eastern, Central, or Mountain time zones of the United States, who are looking for a dynamic and supportive work environment. As a Clinical Research Associate at KCR, you will play a key role in executing and overseeing clinical trials, ensuring compliance with regulatory requirements, and driving the successful completion of projects in the oncology therapeutic area.

Key Responsibilities:

Site Monitoring: Perform site visits in line with study protocol, GCP/ICH guidelines, and regulatory requirements.
Project Leadership: Provide feedback and suggestions for project success, working closely with project teams to ensure deadlines, quality, and project objectives are met.
Oncology Expertise: Focus on oncology and early-phase clinical trials, bringing your deep knowledge to the monitoring process.
Mentorship & Coaching: Mentor and lead junior CRAs, providing guidance and support for their development and training.
KPI Management: Ensure key performance indicators (KPIs) are met for assigned sites and staff, ensuring timely and quality deliverables.
Training Development: Lead the development and implementation of training programs to enhance the skills of assigned staff.

Requirements:

Education: Bachelor’s degree in life sciences, pharmacy, biotechnology, nursing, or a related field from an accredited U.S. college/university.
Experience: At least 2 years of independent monitoring experience in clinical trials, including pre-study, initiation, routine monitoring, and close-out visits.
Oncology Experience: Minimum of 1 year of experience in oncology, early-phase clinical trials.
Knowledge: Deep understanding of clinical trial processes, monitoring procedures, and regulatory requirements (GCP/ICH guidelines).
Technical Skills: Proficient in using clinical trial management software and EDC systems.
Travel: Willingness and ability to travel up to 70%.
Language: Fluent in English (written and spoken).

Why KCR?

At KCR, we are committed to supporting our employees’ professional growth, ensuring work-life balance, and fostering a culture of inclusivity. We offer a competitive salary, exceptional benefits, and a collaborative work environment where your input is valued.

Benefits:

33 PTO days (inclusive of recognized holidays and 1 additional day for your birthday)
Comprehensive healthcare and wellbeing benefits (private health plans, life insurance, disability insurance, travel insurance)
Retirement benefits (private retirement fund)
Loyalty and Referral Programs
Access to training programs to develop sector knowledge and clinical trial expertise
The latest technology and working tools to support your success
A flat hierarchical structure with open communication and direct access to management for idea-sharing and continuous improvement

About KCR:

Founded in 1997, KCR is a clinical development solutions provider delivering comprehensive clinical trial services across North America, Europe, and Australia. With expertise in Trial Execution, Consulting, and Placement, we support biotechnology and pharmaceutical organizations in developing life-changing therapies. Our geographical reach spans over 25+ countries, and our dedicated team ensures the highest standards of clinical trial management.

Join our team and make a difference in the world of oncology clinical research.

Apply Now!

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Clinical Research Associate Ii Or Senior - Oncology Required

Job Description

About the Role:

Key Responsibilities:

Requirements:

Why KCR?

Benefits:

About KCR:

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