Centralized Study Spec I

Summary of Responsibilities:

• 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.

Qualifications (Minimum Required):

• University/College Degree (Life Science preferred), or certification in an allied health profession from an appropriate accredited institution (Ex. Nursing certification, Medical or laboratory technology) and 5-8 years of work.
• Experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

• 5-8 Years of experience in the job discipline.
• 0-5 Years of experience in other professional roles.
• Other required work-related experiences:
• Demonstrated ability to plan, prioritize, organize, and communicate effectively.
• Demonstrated ability to pay attention to detail.
• Strong interpersonal skills with ability to work well with others.
• Ability to deliver consistent high quality of work.
• Strong interpersonal skills.
• Ability to Influence others.
• Ability to facilitate meetings.
• Ability to lead process improvement initiatives.

Preferred Qualifications Include:

• Candidate should be able to work in shifts if business demands for it.
• May involve extensive use of computer and keyboard.

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