Bilingual French Cra - Oncology

0-2 years

Not Disclosed

Remote, USA

10 Nov. 4, 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

Clinical Research Associate (CRA)

Description
As a Clinical Research Associate, you will be joining the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence.

What You Will Be Doing:

Ensure regulatory, ICH-GCP, and protocol compliance, using judgment and experience to evaluate site performance and provide actionable recommendations. Communicate and escalate significant issues to the project team promptly and develop action plans. Maintain a strong knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
Verify that the informed consent process has been properly performed and documented for each subject/patient, protecting their confidentiality and assessing factors that could impact safety and clinical data integrity at investigator sites.
Conduct monitoring activities according to the Clinical Monitoring/Study Monitoring Plan (CMP/SMP), using both on-site and remote methods as permitted by country regulations.
Perform Source Document Review and Source Data Verification of appropriate site source documents and medical records.
Ensure that required clinical data entered in case report forms (CRFs) is accurate and complete, managing the reporting of protocol deviations and necessary follow-up.
Apply query resolution techniques both remotely and on-site, providing guidance to site staff and driving queries to closure within agreed timelines.
Utilize available hardware and software to support effective clinical study data review and capture.
May perform investigational product (IP) inventory, reconciliation, and security reviews, ensuring compliance with protocols regarding dispensing and administration to subjects/patients.
Document activities via follow-up letters, monitoring reports, communication logs, and other required project documents as per SOPs and the Clinical Monitoring Plan/Study Monitoring Plan.
Ensure all site activities are managed by personnel who are properly trained and delegated.
Enter data into tracking systems to monitor observations, ongoing statuses, and assigned action items to resolution.
Understand project scope, budgets, and timelines; manage site-level activities and communication to ensure project objectives and deliverables are met, adapting quickly to changing priorities.
Review data entry timelines, missing pages, outstanding data queries, and timelines for database locks.
Collaborate with the primary Site Manager as the main liaison with site personnel.
Prepare for and attend Investigator Meetings and sponsor face-to-face meetings, participating in global clinical monitoring/project staff meetings and clinical training sessions as required.
Provide guidance towards audit readiness standards at the site and project level and support preparations for audits and follow-up actions.

You Are:

Training and Education

Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.

Prior Experience

Minimum of 12 months of experience as a clinical monitor with demonstrated experience in monitoring (virtual or onsite).

Technical Competencies

Knowledge of Good Clinical Practice/ICH Guidelines and relevant regulatory requirements.
Proficient in computer skills and adaptable to new technologies.
Excellent communication, presentation, and interpersonal skills.
Strong networking and relationship-building abilities.
Ability to manage required travel of up to 75% regularly.
Effective communication with internal and external stakeholders.
Demonstrated experience with systems like Siebel CTMS, eTMF, eISF (Florence), or ability to adapt quickly to new systems for monitoring.

Behavioral Competencies

Skilled in overcoming barriers during the implementation of new processes and systems.
Ability to build effective relationships with investigator site staff and stakeholders.
Strong verbal and written communication skills.

What ICON Can Offer You:
Our success relies on the quality of our people. That’s why we prioritize building a diverse culture that rewards high performance and nurtures talent.

In addition to a competitive salary, ICON offers a range of benefits focused on well-being and work-life balance, including:

Various annual leave entitlements
Health insurance options for you and your family
Competitive retirement planning
Global Employee Assistance Program for 24-hour access to support
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, gym memberships, and more.

To learn more about the benefits of working at ICON, visit our careers website.

At ICON, diversity, inclusion, and belonging are fundamental to our culture. We are committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. If you require reasonable accommodation during the application process, please let us know through the form here.

If you’re interested in this role but unsure about meeting all the requirements, we encourage you to apply anyway—you might be exactly what we’re looking for!