Clinical Research Associate Ii (Cra Ii)

2+ years

Not Disclosed

Remote

10 Aug. 23, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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

Fortrea is a leading global Contract Research Organization (CRO) dedicated to scientific excellence and with decades of clinical development experience. We offer a broad spectrum of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With a team of over 19,000 professionals operating in more than 90 countries, Fortrea is at the forefront of transforming drug and device development for our partners and patients worldwide.

Position: Clinical Research Monitor

Summary of Responsibilities:

Site Monitoring: Oversee all aspects of study site monitoring, including routine visits, close-out of clinical sites, maintenance of study files, and conducting pre-study and initiation visits. Liaise with vendors as needed and handle other assigned duties.
Site Management: Manage site activities according to project plans, ensuring compliance with protocol requirements.
On-Site Monitoring: Ensure study staff have the necessary materials and instructions to safely enroll patients. Verify adherence to informed consent procedures and protocol requirements.
Data Integrity: Review and verify data submitted on Case Report Forms (CRFs) or other data collection tools. Monitor data for accuracy and completeness.
Resource Management: Perform monitoring tasks efficiently according to SOPs and guidelines. Manage travel expenses in line with Fortrea's travel policy.
Audit Readiness: Ensure sites are prepared for audits and inspections.
Travel Requirements: Travel, including air travel, is a core aspect of the job.
Trip Reports: Prepare accurate and timely reports of site visits.
Registry Management: Oversee all aspects of registry management as detailed in project plans.
Feasibility and Quality Control: Assist with feasibility work, participate in Quality Control Visits (QC), and follow up as needed.
Study Administration: Recruit potential investigators, handle ethics committee submissions, notify regulatory authorities, manage translations, organize meetings, and perform other tasks as directed by supervisors.
Client Interaction: May work directly with clients as required.
SAE Tracking: Track and follow up on Serious Adverse Events (SAEs), including report production and narrative preparation.
Data Management: Conduct CRF reviews, generate and resolve queries according to data review guidelines on Fortrea or client data management systems.
Training: Assist in training new employees and co-monitoring activities.
Project Coordination: Coordinate clinical projects as a Local Project Coordinator with supervision and act as a local client contact if assigned.
Additional Duties: Perform other tasks as assigned by management.

Experience and Qualifications:

Experience: Minimum of 2 years in Clinical Monitoring or an equivalent combination of education and experience.
Skills: Ability to independently monitor study sites according to protocol, SOPs, and regulatory guidelines. Proficiency in SAE reporting, good planning, organization, and problem-solving skills. Strong communication, interpersonal, analytical, and negotiation skills. Competent in computer use.
Languages: Fluent in both the local office language and English, both written and verbal.
Education: University or college degree or certification in a related health profession (e.g., nursing licensure). Equivalent experience may be considered. Knowledge of ICH Guidelines and local regulatory requirements, monitoring procedures, and the clinical trial process is essential. A valid driver’s license is required.

Why Join Fortrea?

Fortrea is committed to innovation and overcoming challenges in clinical trials. We aim to revolutionize the development process, ensuring the rapid delivery of life-changing therapies. Join our dynamic team and enjoy a collaborative environment that fosters personal growth and global impact. For more information, visit www.fortrea.com.

Equal Opportunity Employer:

Fortrea is an Equal Opportunity Employer dedicated to diversity and inclusion. We do not tolerate harassment or discrimination and make employment decisions based on individual qualifications and business needs. We encourage all qualified candidates to apply, regardless of race, religion, color, national origin, gender (including pregnancy or medical conditions/needs), family status, sexual orientation, gender identity, age, veteran status, disability, or any other legally protected characteristic.

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Clinical Research Associate Ii (Cra Ii)

Job Description

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