Bilingual French Cra - Oncology

2+ years

Not Disclosed

Remote, USA

10 Nov. 5, 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

Job Title: Clinical Research Associate (CRA) - Remote
Location: Remote (U.S.)
Company: ICON plc

About ICON plc

ICON plc is the world’s largest and most comprehensive clinical research organization (CRO), powered by healthcare intelligence. We partner with global pharmaceutical, biotechnology, medical device, and public health organizations to accelerate the development of treatments that save lives and improve quality of life. ICON is committed to fostering a culture of diversity, inclusion, and innovation, making it an exciting place to advance your career in clinical research.

Position Overview

We are looking for a Clinical Research Associate (CRA) to join our team and help us maintain high standards of clinical research through regulatory compliance, protocol adherence, and site management. As a CRA, you will play an essential role in the successful monitoring and management of clinical trials, ensuring the accuracy and integrity of clinical data and patient safety across study sites. This position is fully remote with travel required (up to 75%).

Key Responsibilities

Site Monitoring and Compliance

Ensure regulatory compliance, adherence to ICH-GCP guidelines, and protocol fidelity at study sites.
Evaluate overall site performance and provide recommendations for site-specific actions when issues arise.
Review and verify informed consent processes are properly performed and documented for each subject, ensuring patient confidentiality and safety.
Conduct Source Document Review and Source Data Verification to ensure the accuracy and completeness of clinical data.
Identify and manage protocol deviations and issues related to patient safety and data integrity.
Apply appropriate query resolution techniques and work with site staff to ensure data issues are resolved promptly.

Investigational Product Management

Oversee Investigational Product (IP) inventory, reconciliation, and security, ensuring proper dispensation per protocol.
Verify that IP is appropriately handled, stored, labeled, and returned or disposed of in accordance with local regulations and study requirements.

Site Support & Communication

Collaborate with Site Managers and ensure all site personnel are appropriately trained and delegated responsibilities according to the study protocol.
Monitor clinical and non-clinical equipment and supplies at the site, ensuring they meet the study's requirements and are within their expiration dates.
Ensure site logs (e.g., Screening & Enrollment Log, Investigational Product Accountability Log) are up to date and maintained correctly.
Participate in investigator meetings and other relevant project meetings, contributing to site-specific needs and study progress.

Project Management and Reporting

Review and ensure timely data entry in the case report form (CRF), monitor for missing pages or outstanding data queries, and track progress towards database locks.
Document all activities, observations, and resolutions via monitoring reports, communication logs, and other required project documents.
Ensure that the site signature sheet and delegation of duties log are up to date, and confirm that all site personnel are trained in new protocol amendments or training updates.

Audit Readiness & Continuous Improvement

Provide guidance on audit readiness and assist in preparing for site audits, ensuring necessary follow-up actions are completed.
Stay informed on the latest technologies, industry best practices, and evolving processes, contributing to process improvements for clinical monitoring activities.

Qualifications & Skills

Education & Experience

Bachelor’s degree or equivalent in a related field (e.g., Life Sciences, Nursing).
A minimum of 12 months of experience as a clinical monitor (onsite or virtual), with hands-on experience in clinical trial monitoring.

Technical Competencies

In-depth knowledge of ICH-GCP Guidelines, regulatory requirements, and SOPs.
Strong computer skills and familiarity with systems like Siebel CTMS, eTMF, and eISF (Florence), or the ability to quickly adapt to new tools.
Experience with investigational product management, including inventory, reconciliation, and storage.
Ability to conduct remote monitoring when allowed by country regulations.
Excellent communication, presentation, and interpersonal skills, with a proven ability to build effective relationships with site staff and project teams.

Behavioral Competencies

Strong problem-solving skills and the ability to adapt quickly to changing priorities or environments.
Proven ability to overcome barriers in process implementation and ensure smooth study progression.
A self-starter with the ability to manage time and tasks effectively across multiple sites and stakeholders.

What ICON Can Offer You

At ICON, we value our employees and prioritize their well-being. In addition to competitive pay, ICON offers a comprehensive benefits package designed to support work-life balance, professional growth, and personal well-being. Benefits include:

Annual leave entitlements
Health insurance tailored to you and your family’s needs
Retirement planning options to help you save for the future
Life assurance
Access to the Global Employee Assistance Program (TELUS Health) for 24/7 support
Additional country-specific benefits, including childcare vouchers, gym memberships, and health assessments

Why ICON?

ICON is a leader in clinical research and a workplace where innovation and diversity thrive. Our success is driven by our employees, and we are committed to fostering a collaborative, inclusive, and supportive environment. We offer opportunities for growth and a commitment to workplace diversity to ensure all employees can bring their best selves to work.

ICON is an Equal Opportunity Employer
We are committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. If you require a reasonable accommodation during the application process or need assistance in performing the essential functions of the position, please let us know.

Application Instructions
If you’re interested in this opportunity and meet the qualifications, we encourage you to apply! Even if you’re unsure if you meet all of the requirements, we invite you to apply—there’s every chance you’re exactly what we’re looking for at ICON.