Cra I

2+ years

Not Disclosed

Remote, USA

10 Oct. 16, 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
As a Clinical Research Associate (CRA), you'll join the world's largest and most comprehensive clinical research organization, powered by healthcare intelligence.

What You Will Be Doing:

Ensure compliance with regulatory standards, ICH-GCP guidelines, and study protocols. Utilize your judgment to assess site and staff performance, providing recommendations for site-specific actions. Communicate and escalate significant issues to the project team promptly, developing action plans as necessary. Maintain a thorough understanding of applicable regulations, guidelines, and company SOPs.
Verify that the informed consent process is executed and documented for each subject as required, ensuring confidentiality and assessing factors affecting subject safety and clinical data integrity, including protocol deviations and pharmacovigilance issues.
Conduct monitoring activities according to the Clinical Monitoring/Study Monitoring Plan (CMP/SMP), using both on-site and remote methods where regulations allow. Perform Source Document Review and Source Data Verification of site documents and medical records.
Confirm that clinical data entered in case report forms (CRFs) is accurate and complete. Manage protocol deviation reporting and follow-up, applying query resolution techniques both remotely and on-site, guiding site staff as needed to achieve timely resolution.
Utilize hardware and software effectively for data review and capture. Manage investigational product (IP) inventory and ensure compliance with labeling and storage regulations. Verify that IP is dispensed and administered per protocol and manage any associated risks.
Document all activities through follow-up letters, monitoring reports, and communication logs, ensuring that all site personnel are appropriately trained and delegated tasks.
Enter data into tracking systems to monitor observations, statuses, and action items. Understand project scope, budgets, and timelines to manage site-level activities and ensure project objectives are met. Adapt quickly to changing priorities.
Review data entry timeliness, missing pages, outstanding queries, and database lock timelines. Confirm that the site’s Signature Sheet and Delegation of Duties Log are current and assess compliance with any new training requirements.
Collaborate closely with the primary Site Manager, attending Investigator Meetings and sponsor meetings, and participate in global clinical monitoring/project staff meetings.
Provide guidance towards audit readiness and support preparation for audits and follow-up actions.

You Are:

Training and Education

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

Prior Experience

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

Technical Competencies

Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements.
Strong computer skills and adaptability to new technologies.
Excellent communication, presentation, and interpersonal skills, with demonstrated networking and relationship-building abilities.
Willingness to travel up to 75% regularly and communicate effectively with internal and external stakeholders.
Experience with systems like Siebel CTMS, eTMF, or eISF (Florence), or the ability to quickly learn new systems.

Behavioral Competencies

Proven ability to overcome barriers during the implementation of new processes and systems.
Strong skills in building effective relationships with site staff and stakeholders.
Effective verbal and written communication skills.

What ICON Can Offer You:

Our success relies on the quality of our people. 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 designed to promote well-being and work-life balance, including:

Various annual leave entitlements.
A variety of health insurance options tailored to you and your family’s needs.
Competitive retirement planning offerings.
Global Employee Assistance Program, providing 24-hour access to a network of specialized professionals.
Life assurance.
Flexible country-specific optional benefits, such as childcare vouchers, bike purchase schemes, discounted gym memberships, and more.

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

At ICON, diversity, inclusion, and belonging are fundamental to our culture. Our diverse workforce enhances our innovation and helps us better serve our communities. We are committed to providing an inclusive environment free from discrimination and harassment. All qualified applicants will receive equal consideration for employment.

If you need a reasonable accommodation during the application process or to perform essential job functions due to a medical condition or disability, please let us know through this form: Request for Reasonable Accommodations.

Interested in the role but unsure if you meet all the requirements? We encourage you to apply anyway—there’s a good chance you’re just what we’re looking for at ICON, whether for this role or