(Senior) Centralized Study Associate

3-5 years

Not Disclosed

Remote, USA

10 Aug. 2, 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) with a commitment to scientific excellence and extensive experience in clinical development, Fortrea offers a broad range 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 over 90 countries, we are at the forefront of advancing drug and device development for our partners and patients worldwide.

We are excited to announce the establishment of a Centralized Delivery Hub in Bulgaria and are currently seeking experienced Study Specialists to join our team!

Key Responsibilities:

Adhere to all departmental Standard Operating Procedures (SOPs) and Work Instructions.
Execute day-to-day tasks with a focus on maintaining quality and productivity.
Track and report metrics as determined by management within required timelines.
Engage in process improvement opportunities and assist in implementing revised processes and procedures.

Additional Responsibilities:

Manage clinical systems and access management.
Oversee study documents and support eTMF management.
Maintain study databases (CTMS, IWRS, EDC, etc.) and support data review activities.
Track and follow up with CRAs on outstanding issues.
Assist in generating study-specific reports and managing internal and external communications.
Ensure training compliance for study teams and manage study payments (site and vendor).
Document and track study activities using relevant forms, tools, and Project Management Systems.
Maintain Trial Master File (TMF) documentation, participate in TMF QC, and manage project timelines and milestones.
Update and manage the Xcellerate Risk Identification & Issue Resolution (XRIM) tool and address outstanding action items, including Protocol Deviations.
Draft or assist Functional Leads with project plans, coordinate review and execution between study team and client.
Collaborate with the Study Team to maintain WISER moments and facilitate team communication and meetings.
Oversee vendor management and perform additional cross-functional tasks as needed.

Qualifications:

University/College Degree in Life Sciences (preferred) or certification in an allied health profession (e.g., Nursing, Medical or Laboratory Technology) from an accredited institution.
3-5 years of experience in clinical research with a strong working knowledge of ICH-GCP guidelines and relevant regulations.
Fortrea may consider equivalent relevant experience in place of formal educational requirements.

Why Join Us:

Fortrea is dedicated to overcoming barriers in clinical trials and revolutionizing the development process to deliver life-changing therapies to patients swiftly. By joining our team, you will be part of a collaborative environment that fosters personal and professional growth, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Equal Opportunity Employer:

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

For details on how we collect and store your personal data, please review our Privacy Statement.

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(Senior) Centralized Study Associate

Job Description

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