Senior Centralized Study Asso

2+ years

Not Disclosed

Bangalore

10 Nov. 8, 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

About Fortrea
Fortrea is a global leader in contract research with a passion for scientific excellence and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device companies with a comprehensive range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Operating in over 90 countries, Fortrea is driving innovation and transforming the drug and device development process for our partners and patients worldwide.

Position Overview

We are seeking a Clinical Operations Coordinator to play a key role in supporting clinical trials by ensuring seamless execution of tasks related to clinical systems management, document control, study databases, and team communications. The ideal candidate will be organized, detail-oriented, and able to handle multiple tasks while ensuring high standards of quality and productivity.

Key Responsibilities

Clinical Systems & Study Management

Follow applicable Standard Operating Procedures (SOPs) and Work Instructions for the department.
Complete day-to-day clinical operations tasks, ensuring productivity and quality are maintained.
Track and report metrics as determined by the management team, meeting required timelines.
Support the management of clinical systems (e.g., CTMS, IWRS, EDC).
Maintain and manage study documentation, including participation in eTMF management and tracking.
Support data review activities and provide assistance in generating study-specific reports.
Assist with study payments (site and vendor) and ensure all financial documentation is accurate and timely.
Manage and track study activities using relevant project management tools and systems, ensuring all activities are documented.
Ensure that study documentation is maintained and updated in the Trial Master File (TMF), participating in TMF QC and archiving activities as needed.

Communication & Collaboration

Act as a key point of contact for internal and external communications related to the study.
Organize and participate in team meetings, facilitating collaboration across functions.
Document and distribute meeting notes, action items, and follow-up tasks as required by study protocols.
Coordinate with Clinical Research Associates (CRAs) and study team members to resolve outstanding issues and escalate risks as necessary.
Support training compliance for study teams, ensuring that all team members meet training requirements.
Assist with the onboarding of new team members and ensure they are properly trained.

Risk & Issue Management

Update and track timelines, milestones, and risks in project scheduling tools, including Xcellerate Risk Identification & Issue Management (XRIM).
Follow up on unresolved action items and protocol deviations, ensuring issues are tracked and resolved.
Provide support for process improvement initiatives and assist in the implementation of revised processes and procedures.

Vendor Management & Oversight

Support vendor management activities and ensure proper oversight of third-party relationships as necessary.

Qualifications

Experience

2+ years of experience in clinical operations or related roles within a CRO or pharmaceutical environment.
Strong experience with clinical systems management (CTMS, IWRS, EDC) and study documentation management.
Proven ability to work in a fast-paced environment and handle multiple priorities simultaneously.
Experience working with clinical trial teams and managing day-to-day study tasks.

Education

Bachelor’s degree in a related field (e.g., Life Sciences, Healthcare, or Business).
Relevant certifications (e.g., Clinical Research Coordinator (CRC), Good Clinical Practice (GCP)) are preferred but not required.

Skills

Strong communication and organizational skills.
Ability to work collaboratively across departments and with external vendors.
Proficient in project management software and tools.
Ability to handle confidential information with integrity and professionalism.
Detail-oriented with a strong focus on meeting deadlines and maintaining study compliance.

Why Join Fortrea?

Fortrea offers a collaborative and supportive environment where you can grow professionally and make a real impact in the world of clinical trials. As part of a dynamic and diverse team, you will have the opportunity to help bring life-changing therapies to patients while working with cutting-edge technology and global leaders in clinical research.

For more information about Fortrea and to explore other career opportunities, visit www.fortrea.com.

Equal Opportunity Employer

Fortrea is an Equal Opportunity Employer. We believe in creating a diverse and inclusive workforce and do not tolerate harassment or discrimination of any kind. We make employment decisions based on the individual’s qualifications and the needs of our business.

We encourage applicants of all backgrounds to apply. Fortrea is an EOE/AA employer, committed to diversity and inclusion in the workforce.