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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 scientific rigor and extensive experience in clinical development. We offer a comprehensive range of clinical development, patient access, and technology solutions across over 20 therapeutic areas. With a team of more than 19,000 professionals operating in over 90 countries, Fortrea is dedicated to transforming drug and device development for partners and patients worldwide.

Position: Contracts Specialist

Responsibilities:

  1. Adherence to SOPs: Ensure strict adherence to standard operating procedures (SOPs) and work instructions.

  2. Contracts Management: Maintain and contribute to contract tracking and status systems, including the upkeep of both paper and electronic file systems.

  3. Agreement Processing: Perform processing and maintenance of agreements with guidance from line management and department colleagues.

  4. Coordination: Collaborate with clinical study teams to manage contract details, timelines, and status reporting.

  5. Support Contracts Specialists: Assist in populating, mailing, scanning, and tracking contracts, ensuring timely delivery and follow-up.

  6. Process Improvement: Engage in discussions with department colleagues to enhance departmental processes and procedures.

  7. Compliance Monitoring: Monitor assigned studies to ensure compliance with internal processes and Sponsor requirements.

  8. Issue Identification: Identify and escalate any problems or issues with departmental processes to the Manager, Site Agreements.

  9. Review and Negotiation: Review amendments, including clinical study documents and protocol/ICF amendments, and negotiate with sites and sponsors to finalize contracts.

  10. Additional Duties: Perform other responsibilities as required by the department.

Why Join Us?

Fortrea is looking for motivated problem-solvers and innovative thinkers who are passionate about overcoming barriers in clinical trials. We are committed to revolutionizing the development process and delivering life-changing therapies to patients. Join us to work in a collaborative environment where your professional growth is supported, and you can make a significant global impact.

For more information about Fortrea and to apply, visit www.fortrea.com.

Equal Opportunity Employer

Fortrea is an Equal Opportunity Employer committed to diversity and inclusion. We do not tolerate harassment or discrimination of any kind and make employment decisions based on individual qualifications and business needs. We encourage all qualified candidates to apply.

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