Summary of Responsibilities:
- Work with PA to generate cover letter or Proforma invoice and payment batch generation in CTMS.
- Review EDC, Contract, and mark line items “Ready to Pay/Screen Failure” 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.
Learn more about our EEO & Accommodations request here.
