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Site Readiness And Regulatory Specialist 1

5+ years
Not Disclosed
10 Sept. 5, 2024
Job Description
Job Type: Full Time 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 Fortrea

Fortrea, a leading global Contract Research Organization (CRO), is renowned for its commitment to scientific rigor and extensive experience in clinical development. We deliver a comprehensive range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 professionals operating in more than 90 countries, Fortrea is at the forefront of transforming drug and device development worldwide.

Position Overview

We are seeking a detail-oriented and proactive individual to join our team. In this role, you will be responsible for ensuring adherence to standard operating procedures (SOPs), managing contracts, and supporting the clinical study teams. Your efforts will contribute to the efficient processing of agreements and compliance with internal and sponsor requirements.

Key Responsibilities

  1. Adhere to SOPs: Ensure strict adherence to standard operating procedures and departmental guidelines.

  2. Contract Management: Maintain and update contract tracking systems, manage both paper and electronic files, and support the processing of agreements.

  3. Coordination: Work with clinical study teams to coordinate contract details and timelines, and report on contract status.

  4. Support Contracts Specialists: Assist in the preparation, mailing, scanning, and tracking of contracts, ensuring timely delivery and follow-up.

  5. Process Improvement: Engage in discussions to enhance departmental processes and procedures.

  6. Compliance Monitoring: Monitor assigned studies to ensure compliance with internal processes and sponsor requirements.

  7. Issue Resolution: Identify and escalate issues related to departmental processes and procedures to the Manager, Site Agreements.

  8. Contract Review and Negotiation: Review amendments and clinical study documents, including protocols and informed consent form amendments, and negotiate with sites and sponsors to finalize contracts.

  9. Additional Duties: Perform other duties as assigned by the department to support overall operations.

Why Join Us?

Fortrea is dedicated to overcoming challenges in clinical trials and revolutionizing the development process to deliver life-changing therapies to patients. Join our dynamic team to work in a collaborative environment where your personal growth is supported and where you can make a significant global impact.

Equal Opportunity Employer

Fortrea is committed to diversity and inclusion in the workforce and does not tolerate discrimination or harassment of any kind. We make employment decisions based on business needs and individual qualifications without regard to race, religion, color, national origin, gender (including pregnancy and medical conditions), family or parental status, marital status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.

For more information on how we handle your personal data, please refer to our Privacy Statement.

Learn More

To learn more about Fortrea and our innovative work in clinical trials, visit www.fortrea.com.