Company Overview
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Position Overview
We are seeking a dedicated Sr Centralized Study Associate to join our team. The successful candidate will be responsible for:
Responsibilities
Clinical Systems & Access Management:
Managing clinical systems and access.
Maintaining study databases (CTMS, IWRS, EDC, etc.).
Supporting the study team in data review and other related activities.
Tracking and following up with CRAs for outstanding issues.
Generating study-specific reports.
Managing internal/external communications.
Assisting in ensuring training compliance for study teams.
Managing study payments (Site and Vendor).
Data Review:
Following up with CRAs for resolution of outstanding issues/action items.
Assisting the Lead with study-specific data review tasks.
Drafting and sending study-specific reports.
Performing other data review-related tasks as instructed by the project team.
Document Review:
Reviewing Initial/Amended Investigator Packages for regulatory compliance.
Reviewing amended Country/Site Informed Consent Forms.
Filing amended Informed Consent Forms and Investigator Package approval documentation in TMF and eTMF.
Reviewing Investigator Package Plans as per SOP with manager oversight.
Study Support:
Generating study reports and performing analysis.
Managing access on applicable study systems.
Setting up study systems for new awarded studies.
Ensuring CTMS compliance.
Managing project communications.
Assisting project teams with study support activities.
Investigator Payments:
Reviewing EDC, contracts, and marking line items for payment.
Coordinating payment batch generation in CTMS.
Performing invoice QC and preparing GIA as applicable.
Coordinating with CTL and PM for approvals.
Processing Out of Pocket and Pass-Through Expense Invoices.
Performing payment reconciliation.
General Responsibilities:
Following all applicable departmental SOPs and Work Instructions.
Completing required trainings within specified timelines.
Ensuring quality and productivity in day-to-day tasks.
Managing project and technical documentation appropriately.
Providing administrative and technical support to internal departments.
Ensuring quality checks of completed work.
Ensuring timely escalation and issue resolution.
Tracking and reporting metrics as determined by management.
Participating in process improvement opportunities.
Assisting in document management and preparation of new investigator submission packages.
Supporting study start-up activities and site clinical trial contracts management.
Qualifications (Minimum Required)
University/College Degree (Life Science preferred) or certification in an allied health profession from an accredited institution (e.g., Nursing certification, Medical or laboratory technology).
3-5 years of work experience in clinical research, with a strong working knowledge of ICH-GCP guidelines and all other applicable guidelines and regulations.
Relevant and equivalent experience may be considered in lieu of educational requirements.
Experience (Minimum Required)
1-2 years in relevant experience to this role.
Demonstrated ability to organize and communicate effectively.
Attention to detail and high-quality work delivery.
Ability to work well with others and use computer and departmental tools effectively.
Company Commitment
Fortrea is actively seeking 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.
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. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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