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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

As a leading global contract research organization (CRO) with a dedication to scientific excellence and extensive experience in clinical development, Fortrea offers a comprehensive array of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With a team of over 19,000 professionals working in more than 90 countries, Fortrea is driving innovation in drug and device development to benefit partners and patients worldwide.

Key Responsibilities:

  1. Ensure adherence to Standard Operating Procedures (SOPs).
  2. Maintain and update contract tracking and status systems, supporting both paper and electronic file management.
  3. Perform basic processing and maintenance of agreements under the guidance of line management and department colleagues.
  4. Coordinate with clinical study teams to manage contracting details, timelines, and contract status reporting.
  5. Assist Contracts Specialists with tasks such as populating, mailing, scanning, and tracking contracts, and follow up to ensure timely returns.
  6. Participate in discussions with colleagues to enhance departmental processes and procedures.
  7. Monitor assigned studies for compliance with internal procedures and sponsor requirements.
  8. Identify and escalate issues or problems with departmental processes to the Manager of Site Agreements.
  9. Review and negotiate amendments to clinical study documents, including Protocols and Informed Consent Forms (ICFs), with sites and sponsors.
  10. Perform other duties as assigned by the department.

Fortrea is looking for motivated problem-solvers and innovative thinkers who share our commitment to overcoming challenges in clinical trials. We are dedicated to transforming the development process, accelerating the delivery of life-changing therapies to patients. Join our dynamic team and experience a collaborative environment that supports personal growth and makes a global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea is committed to fostering a diverse and inclusive workforce and does not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications without regard to race, religion, color, national origin, gender (including pregnancy or 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. We encourage all qualified individuals to apply.