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Centralized Study Spec I

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Fortrea

24d ago

  • Job
    Full-time
    Entry, Junior, Mid & Senior Level
  • Research & Development
  • Bangalore
  • Quick Apply

AI generated summary

  • You must mentor others, follow SOPs, manage documentation, provide admin support, address issues, improve processes, assist with submissions and contracts, and support site start-up activities.
  • You will manage clinical systems, support study documentation and payments, track issues, generate reports, and assist with training and compliance activities while mentoring new team members.

Requirements

  • - Ability to mentor and train others
  • - To follow all applicable departmental Standard Operating Procedures and Work Instructions
  • - To complete required trainings according to required timelines
  • - To manage project and technical documentation in an appropriate manner
  • - To provide administrative and technical support to internal departments and teams as needed
  • - To ensure timely escalation and issue resolution as needed
  • - To proactively identify opportunities for process improvements and support the implementation of process improvement activities
  • - To support the implementation of tools internally to enhance deliverables
  • - To assist in the document management for all documents in the scope of agreed processes/activities or within the scope of GSDM throughout the study duration
  • - To assist in the preparation of new investigator submission packages for site/regulatory submission
  • - To support study team for contracts and budgets activities for investigative sites
  • - To assist the study start-up teams with tasks required for site start up activities
  • - To review, support, manage or assist in managing the site clinical trial contracts in accordance with defined processes and timelines

Responsibilities

  • To complete other duties/activities as assigned by study management team, but not limited to:
  • Manage clinical systems.
  • Manage study documents and support eTMF management.
  • Maintain study databases (CTMS, IWRS, EDC etc.)
  • Track and follow up with CRAs for outstanding issues
  • Support in generating the study specific reports.
  • Manage internal/external communications.
  • Assist in ensuring training compliance for study teams.
  • Assist in study payments (Site and Vendor)
  • Data Review:
  • Follow up with CRA for resolution of the outstanding issues/action items related to assigned tasks.
  • Perform Associate Lead/Lead role for assigned projects.
  • Draft and send study specific reports as per the study team instructions.
  • Collaborate with DM, Programming team for reports and communication of data related tasks.
  • Perform any other data review related tasks as per the project team instructions.
  • Study Support:
  • Generate Study Reports and perform analysis.
  • Perform Access management on applicable study systems.
  • Perform study system set up on new awarded studies.
  • CTMS compliance management
  • Manage project communications.
  • Assist project teams for other study support activities.
  • Investigator Payments:
  • Review EDC, Contract, and mark line items “Ready to Pay/Screen Failure” in CTMS
  • Work with PA to generate cover letter or Proforma invoice and payment batch generation in CTMS.
  • Perform Invoice QC and Prepare GIA as applicable.
  • Coordinate with CTL, PM for line-item approvals and GIA approvals
  • Process Out of Pocket and Pass-Through Expense Invoices
  • Perform payment reconciliation during the study close out or on ad hoc request by the study team.
  • Act as a mentor and provide training to new joiners in team.
  • Performing quality check of the work delivered by the team as a part of the QC process.
  • To follow all applicable departmental Standard Operating Procedures and Work Instructions.
  • To complete required trainings according to required timelines.
  • To complete day-to-day tasks ensuring quality and productivity.
  • To manage project and technical documentation in an appropriate manner.
  • To provide administrative and technical support to internal departments and teams as needed.
  • To perform checks to ensure quality of work completed.
  • To ensure timely escalation and issue resolution as needed.
  • To execute high quality, timely monitoring and reporting plan(s) including specialized monitoring requests for approved protocols.
  • To support implementation of new monitoring tools.
  • To track and report metrics as determined by management according to required timelines.
  • To proactively identify opportunities for process improvements and support the implementation of process improvement activities.
  • To support the implementation of tools internally to enhance deliverables.
  • Ability to mentor and train others.
  • To assist in the document management (including document template creation, collection, review, processing and tracking up to eTMF filing) for all documents in the scope of agreed processes/activities or within the scope of GSDM throughout the study duration.
  • To assist in the preparation of new investigator submission packages for site/regulatory submission.
  • To support study team for contracts and budgets activities for investigative sites
  • To assist the study start-up teams with tasks required for site start up activities.
  • To review, Support, Manage or assist in Managing the site clinical trial contracts in accordance with defined processes and timelines.

FAQs

What are the primary responsibilities of a Centralized Study Spec I at Fortrea?

The primary responsibilities include managing clinical systems, study documents, and databases, handling communications, assisting with investigator payments, performing data review, generating study reports, ensuring training compliance, and supporting study teams with various tasks.

What qualifications are required for this position?

While specific qualifications may vary, candidates typically need a relevant degree in life sciences or a related field, along with experience in clinical research and a strong understanding of clinical trial processes.

Is training provided for new employees?

Yes, training is provided for new employees to ensure they are equipped with the necessary knowledge and skills for their roles.

What kind of career growth opportunities are available at Fortrea?

Fortrea encourages personal growth and offers opportunities for career advancement, mentoring, and training for individuals who demonstrate motivation and creativity in their work.

How does Fortrea promote diversity and inclusion within the workforce?

Fortrea actively strives for diversity and inclusion by making employment decisions based on the needs of the business and individual qualifications, ensuring no discrimination based on legally protected characteristics.

What role does the Centralized Study Spec I play in the study start-up process?

The Centralized Study Spec I assists in the preparation of documents required for site start-up activities, supports contracts and budgets for investigative sites, and helps with site clinical trial contracts management.

Are there opportunities for process improvement in this role?

Yes, the Centralized Study Spec I is expected to proactively identify opportunities for process improvements and support their implementation.

What is the work environment like at Fortrea?

Fortrea promotes a collaborative workspace where personal growth is nurtured, allowing employees to work together to make a meaningful global impact.

How does Fortrea ensure the quality of work completed by the team?

The Centralized Study Spec I is responsible for performing quality checks of team deliverables as part of the quality control process.

What is the process for submitting personal data when applying for a job at Fortrea?

For more information on how Fortrea collects and stores personal data, applicants can refer to the company's Privacy Statement.

Fortrea

Science & Healthcare
Industry
10,001+
Employees
2023
Founded Year

Mission & Purpose

We are creative thinkers with decades of clinical trial experience who drive innovative solutions powered by insights from data and technology. As we tackle challenges in today’s world, we know that we need to be nimble and agile. That’s why we work side-by-side with our partners to eliminate inefficiencies from the process so we can help them deliver life-changing therapies faster for patients, caregivers and healthcare providers worldwide.