Centralized Study Specialist I
hace 23 horas
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.
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.
We are seeking an experienced and highly motivated Centralized Study Specialist I to join our team. This role involves managing clinical systems, supporting study documentation, ensuring compliance, and providing leadership and mentorship to junior team members. The successful candidate will play a pivotal role in the successful execution of clinical trials and contribute to process improvement initiatives.
Key Responsibilities:
Clinical Systems Management:
Oversee and manage clinical systems.Maintain study databases (CTMS, IWRS, EDC, etc.).Support eTMF management.Study Coordination:
Track and follow up with CRAs on outstanding issues.Generate study-specific reports.Manage internal and external communications.Ensure training compliance for study teams.Assist in managing study payments (Site and Vendor).Data Review:
Follow up with CRAs for resolution of outstanding issues/action items.Perform Associate Lead/Lead role for assigned projects.Draft and send study-specific reports.Collaborate with Data Management and Programming teams.Perform other data review-related tasks as instructed.Study Support:
Generate and analyze study reports.Manage access on applicable study systems.Set up study systems for newly awarded studies.Ensure CTMS compliance.Manage project communications.Assist project teams with study support activities.Investigator Payments:
Review EDC, contracts, and mark line items for payment.Generate cover letters or Proforma invoices and payment batches.Perform invoice quality checks and prepare GIA.Coordinate with CTL and PM for approvals.Process Out of Pocket and Pass-Through Expense Invoices.Perform payment reconciliation.Mentor and train new team members.Perform quality checks on team deliverables.General Responsibilities:
Follow all departmental Standard Operating Procedures and Work Instructions.Complete required trainings on time.Ensure quality and productivity in day-to-day tasks.Manage project and technical documentation appropriately.Provide administrative and technical support to internal departments.Ensure quality of completed work through checks.Timely escalate and resolve issues.Execute high-quality, timely monitoring and reporting plans.Support the implementation of new monitoring tools.Track and report metrics as required by management.Identify and support process improvement opportunities.Assist in document management and preparation of new investigator submission packages.Support study team for contracts and budget activities for investigative sites.Assist with site start-up activities.Review, support, manage, or assist in managing site clinical trial contracts.Qualifications (Minimum Required):
Education:
University/College Degree in Life Sciences or a related field, or certification in an allied health profession from an accredited institution (e.g., Nursing certification, Medical or Laboratory Technology).Experience:
2-3 years of work experience in clinical research.Strong working knowledge of ICH-GCP guidelines and other applicable regulations.Relevant and equivalent experience may be considered in lieu of educational requirements.Skills:
Demonstrated ability to plan, prioritize, organize, and communicate effectively.Attention to detail and high-quality work delivery.Strong interpersonal skills and ability to work collaboratively.Ability to influence others and facilitate meetings.Experience in leading process improvement initiatives.Ability to mentor and train others.If you are passionate about clinical research and have the required qualifications and experience, we encourage you to apply. Join us in our mission to advance healthcare and improve lives.
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.
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