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Centralized Study Spec I

2+ years
Not Disclosed
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) renowned for its scientific rigor and extensive clinical development experience. We offer a broad spectrum of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With a dedicated team of over 19,000 professionals operating in more than 90 countries, Fortrea is committed to advancing drug and device development for partners and patients worldwide.

Role and Responsibilities:

In this role, you will:

  • Clinical Systems Management: Oversee and manage clinical systems, including study documents and eTMF management. Ensure proper maintenance of study databases such as CTMS, IWRS, and EDC.
  • Issue Tracking and Reporting: Track and follow up on outstanding issues with CRAs. Generate and draft study-specific reports as needed, collaborating with data management and programming teams.
  • Study Support: Generate and analyze study reports, manage system access, and assist with study system setup for new awards. Ensure CTMS compliance and support project communications.
  • Investigator Payments: Review EDC and contracts, process invoices, perform quality checks, and coordinate with project teams for payment approvals and reconciliations.
  • Training and Mentorship: Act as a mentor, providing training to new team members and performing quality checks on their work. Ensure adherence to departmental SOPs and complete required training.
  • Administrative and Technical Support: Provide administrative support, manage project documentation, and ensure high-quality work. Proactively identify opportunities for process improvements and assist with the implementation of new tools.
  • Document and Contract Management: Assist with document management, including creation, collection, review, processing, and tracking up to eTMF filing. Support site and regulatory submissions and contract and budget activities.

Why Fortrea?

Fortrea is seeking innovative and driven individuals who are passionate about overcoming challenges in clinical trials. We are dedicated to revolutionizing the development process to deliver life-changing therapies to patients quickly. Join our collaborative team and experience personal growth while making a significant global impact.

Equal Opportunity Employer:

Fortrea is proud to be an Equal Opportunity Employer. We are committed to diversity and inclusion and do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, regardless of race, religion, color, national origin, gender (including pregnancy or medical conditions), family status, marital status, sexual orientation, gender identity, gender expression, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all qualified individuals to apply.

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

Discover more about Fortrea at www.fortrea.com.