Clinical Research Associate - Home-Based (Us)

2+ years

Not Disclosed

Remote, USA

10 July 23, 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, 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) I, you will join the world's largest and most comprehensive clinical research organization, driven by healthcare intelligence.

Key Responsibilities:

Regulatory Compliance: Ensure adherence to regulatory requirements, ICH-GCP guidelines, and study protocols. Use judgment and experience to evaluate site performance and staff, providing recommendations and escalating significant issues promptly. Develop action plans to address any concerns.
Informed Consent: Verify that informed consent has been properly obtained and documented for each subject/patient, safeguarding confidentiality. Assess factors affecting subject/patient safety and data integrity at the site, including protocol deviations and pharmacovigilance issues.
Monitoring Activities: Conduct monitoring activities per the Clinical Monitoring/Study Monitoring Plan (CMP/SMP) both on-site and remotely, as permitted by regulations.
Source Document Review: Perform source document reviews and source data verification of site documents and medical records. Ensure clinical data entered in case report forms (CRFs) is accurate and complete.
Protocol Deviations: Manage and report protocol deviations, ensuring appropriate follow-up.
Query Resolution: Apply query resolution techniques remotely and on-site, guiding site staff and driving closure within agreed timelines.
Investigational Product Management: Perform inventory and reconciliation of investigational products (IP), ensuring proper storage, security, and administration according to protocols. Address issues related to blinded or randomized information and ensure compliance with GCP/local regulations.
Documentation: Document activities through follow-up letters, monitoring reports, communication logs, and other required project documents. Ensure site personnel are appropriately trained and delegated.
Data Entry Tracking: Enter data into tracking systems to monitor observations, status, and action items to resolution.
Project Management: Understand project scope, budgets, and timelines to manage site-level activities and communication, ensuring project objectives are met. Adapt quickly to changing priorities to achieve goals.
Data Entry Review: Ensure timely data entry, resolve missing pages and outstanding queries, and adhere to timelines for database locks.
Training Compliance: Review site signature sheets and delegation logs to confirm staff changes and assess training compliance.
Site Readiness: Check site facilities, equipment, and supplies to ensure adequacy for trial conduct. Maintain site-specific logs.
Collaboration: Work with the primary Site Manager, attend investigator meetings, and participate in global clinical monitoring/project staff meetings and training sessions.
Audit Readiness: Provide guidance towards audit readiness standards and support audit preparations and follow-ups.

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 experience as a clinical monitor with demonstrated monitoring experience (virtual or onsite).

Technical Competencies:

Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulations.
Proficiency in computer skills and adaptability to new technologies.
Excellent communication, presentation, and interpersonal skills.
Strong networking and relationship-building abilities.
Willingness to travel up to 75% regularly.
Effective communication with internal and external stakeholders.
Adaptability to changing technologies and processes.
Experience with systems like Siebel CTMS, eTMF, eISF (Florence), or similar.

Behavioral Competencies:

Ability to overcome barriers during new process and system implementations.
Strong relationship-building skills with investigator site staff and stakeholders.
Effective verbal and written communication skills.

Why ICON?

ICON offers a comprehensive and competitive total rewards package, including base pay, variable pay, and recognition programs. Our employee benefits, supportive policies, and wellbeing initiatives support you and your family throughout your career. We are committed to developing our employees in a continuous learning culture, providing engaging work that enhances your professional development.

ICON is an equal opportunity and inclusive employer, committed to a discrimination-free workplace. All qualified applicants will receive equal consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. If you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position due to a medical condition or disability, please let us know.

Interested in the role but unsure if you meet all requirements? We encourage you to apply regardless – you may be exactly what we need at ICON for this or other roles.

Actual compensation will be based on factors such as geographic location, work experience, education/training, and skill level.

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Clinical Research Associate - Home-Based (Us)

Job Description

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