Centralized Study Specialist I

Fortrea

2+ years

Not Disclosed

Mumbai Pune

10 July 23, 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, 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), Fortrea brings a passion for scientific rigor and decades of clinical development experience to pharmaceutical, biotechnology, and medical device customers. We offer a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff members operating in more than 90 countries, Fortrea is dedicated to transforming drug and device development for partners and patients worldwide.

Job Summary:

Assist with the overall operations associated with study set-up, planning, and maintenance. The post holder is responsible for supporting team members in providing this service to Sponsor-Investigators, either as a support function to the project groups. The role involves delivering appropriate quality service to both internal and external clients in a safe and cost-effective manner.

Essential Job Duties:

Manage the set-up, planning, and maintenance of clinical studies in the client portal.
Maintain a strong understanding of client conventions or client-specific database conventions, as appropriate.
Participate in the generation of monthly status and other project-specific reports, ensuring the quality and accuracy of metrics and data provided.
Support, train, and mentor less experienced safety staff in all aspects.
Maintain a comprehensive understanding of Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents, and directives.
Participate in project team and internal meetings, as appropriate.
Prepare and support the coordination of ISR study files for archiving at the completion of projects.
Ensure that the IST investigator provides study updates, including regulatory updates, enrollment data, and confirmation that safety information is being transferred to the customer as required. Notify of any amendments to either the protocol or informed consent.
Regularly follow up with customer points of contact for updates on the protocol/study design, and cascade and track this information with the investigator.
Ensure that agreed-upon contractual milestones are being met and raise any threats to milestones or missed milestones to the customer.
Monitor eTMF compliance based on the eTMF filing plan and provide guidance to the Investigator site staff via raised queries in the client communication portal.
Based on the Investigator’s enrollment plan, validate the initial drug supply demand and provide forecasting updates to the client as required.
Support presentations for customer governance calls.
Perform any other duties as assigned by management.

Fortrea actively seeks motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Equal Opportunity Employer:

Fortrea is proud to be an Equal Opportunity Employer. As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. Employment decisions are based on the needs of our business and the qualifications of the individual. We do not discriminate based on race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs)

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Centralized Study Specialist I

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