Senior Centralized Study Asso

2+ years

Not Disclosed

Bangalore

10 Nov. 6, 2024

Job Description

Job Type: Full Time Remote 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

Job Title: Clinical Trial Coordinator
Company: Fortrea
Location: Remote
#LI-Remote

About Fortrea:

Fortrea is a leading global contract research organization (CRO) dedicated to providing scientific rigor and clinical development expertise. We offer a comprehensive range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Operating in over 90 countries, Fortrea is transforming drug and device development, driving innovation and improving patient outcomes globally.

Position Overview:

Fortrea is seeking a Clinical Trial Coordinator to join our growing team. This role plays a vital part in the coordination and management of clinical trials, ensuring all activities are completed according to the study timelines and in compliance with applicable regulations. The Clinical Trial Coordinator will support the study team in a variety of tasks including clinical system management, document handling, vendor management, and ensuring study quality and productivity. This position offers a dynamic environment where you’ll collaborate with cross-functional teams and actively contribute to process improvement initiatives.

Key Responsibilities:

Study Management & Documentation:

Follow SOPs and Work Instructions: Adhere to all applicable departmental Standard Operating Procedures (SOPs) and Work Instructions.
Task Management: Complete day-to-day tasks to ensure quality and productivity while meeting timelines as required.
Data & Document Management: Support in managing study documents and maintaining trial master file (TMF) documentation. Ensure compliance with eTMF management practices.
System Management: Manage clinical systems (CTMS, IWRS, EDC, etc.) and user access.
Study Database Support: Assist in maintaining study databases, ensuring they are up-to-date and accurate.

Team Collaboration & Communication:

Study Team Support: Provide support to the study team with data review and resolution of issues. Track and follow up with Clinical Research Associates (CRAs) for outstanding items.
Communication Management: Manage internal and external communications related to the study, ensuring timely updates and escalation when necessary.
Facilitate Meetings: Support team communication by setting up meetings, documenting meeting minutes, and ensuring proper distribution.
Vendor Management Oversight: Assist with vendor management, including tracking vendor performance and ensuring payments are processed for sites and vendors.

Project Management & Compliance:

Timelines & Milestone Updates: Update project timelines, milestones, and trackers within project management tools, ensuring alignment across the team and escalating any risks.
Risk Identification & Resolution: Use the Xcellerate Risk Identification & Issue Resolution (XRIM) tool to manage and follow up on outstanding action items and protocol deviations.
Compliance Metrics Support: Actively monitor compliance metrics related to TMF, CTMS, and project health. Ensure study teams are in compliance with training and project requirements.

Study Planning & Documentation Support:

Study Plans & Documentation: Assist Functional Leads in drafting project plans and coordinating review, feedback, and execution between the study team and clients.
WISER Moments Support: Help maintain WISER moments and contribute to study planning and process improvement efforts.

Additional Responsibilities:

Process Improvement: Contribute to process improvement opportunities and assist in the implementation of new or revised processes and procedures.
Cross-Functional Support: May assist with additional cross-functional tasks as required by the project.

Qualifications:

Required:

Education: Bachelor’s degree or equivalent experience in a related field (Life Sciences, Healthcare, etc.).
Experience:
- Previous experience in clinical trial coordination or a related field (clinical operations, project management, etc.).
- Knowledge of clinical trial processes and clinical systems (CTMS, EDC, IWRS, etc.).
- Ability to work in a fast-paced environment and manage multiple priorities simultaneously.
- Strong organizational skills with an ability to track and report metrics according to deadlines.

Preferred:

Certifications: Clinical Research Coordinator (CRC) certification or similar credentials are a plus.
Experience with Vendor & Risk Management: Experience in vendor management and risk identification/management is beneficial.

What You Will Get:

Competitive Compensation Package based on skills and experience.
Comprehensive Benefits Package including:
- Health insurance (Medical, Dental, Vision)
- Life Insurance, STD/LTD
- 401(K) plan
- Paid Time Off (PTO) or Flexible Time Off (FTO)
- Employee Stock Purchase Plan (ESPP)
- Company bonus (where applicable)

Why Fortrea?

At Fortrea, we are committed to improving the lives of patients around the world by revolutionizing the clinical trial process. As a Clinical Trial Coordinator, you will play a critical role in ensuring clinical trials are conducted efficiently and in compliance with regulatory standards. This position offers an exciting opportunity to work with a collaborative and innovative team, gain experience across various therapeutic areas, and contribute to life-changing advancements in medicine.

Fortrea is an Equal Opportunity Employer:
Fortrea strives to foster a diverse and inclusive workforce. We do not tolerate discrimination of any kind and encourage applicants from all backgrounds to apply.

Application Deadline:
Applications will be accepted on a rolling basis until the position is filled.

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