Centralized Study Specialist I

Summary of Responsibilities:

• Follow all applicable departmental Standard Operating Procedures and Work Instructions.
• Complete day-to-day tasks ensuring quality and productivity.
• Execute high quality timely monitoring and reporting plan(s) including specialized monitoring requests for approved protocols.
• Track and report metrics as determined by management according to required timelines. Proactively identify opportunities for process improvements and participate in implementation.
• Ability to mentor and train others.
• 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)
• Document and track study activities using relevant forms and tools as well as relevant Project Management Systems with guidance/support; including data related to Clinical SU and VM.
• Prepare CRA Prep Packs and send it to CRAs before the site visit and liase with CRAs and Clinical team to resolve all outstanding queries and issues
• Address all outstanding issues for sites and provide a snapshot of issues to Clinical team including CRAs to make the site visits more effective and efficient.
• Sr. Centralized Study Analyst are expected to take a leadership role in ensuring a successful partnership with other support groups Sr. Centralized Study Analyst are expected to help remove barriers and to facilitate success.
• Maintain Trial Master File documentation within the appropriate TMF platform participate in TMF QC as assigned and track and /archive as applicable.
• May serve as the Sr. Centralized Study Analyst on projects where there is more than one Centralized Delivery Associate or Sr Centralized Delivery Associate (provide guidance facilitate teleconferences task review task delegation)
• Actively support compliance metrics including TMF CTMS and overall project health
• Update timelines and milestones within MS Project CTMS project governance tool and other trackers which may include updates for applicable functions. Escalate when timelines are at risk.
• Can draft or assist Project Lead / FL with project plans and coordinating review feedback and execution between study team (functional leads) and client
• May assist with additional cross-functional tasks according to project needs
• Can draft or assist Project Lead / FL with project plans and coordinating review feedback and execution between study team (functional leads) and client
• May assist with additional cross-functional tasks according to project needs
• Update timelines and milestones within MS Project CTMS project governance tool and other trackers which may include updates for applicable functions. Escalate when timelines are at risk.
• Initiates RIM changes manages PCC Log and supports documentation and impact tracking.
• Assists in vendor management activities including invoice tracker and PO requisitions.
• Handles PII assessments system documentation and updates to XRIM as needed.
• Responsible for implementing any customizations to Xcellerate Intelligence for Trial Efficiency (ITE) at study level upon PM approval.
• Collaborates with the functional lead to ensure timely resolution of XITE alerts within the system.

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).
• Minimum 3 years of experience in clinical development or start-up/ regulatory process or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
• familiarity with investigator start-up documents and contract/budgets negotiation process is preferred
• previous interaction with operational project teams and investigative sites preferred
• Working knowledge of ICH RA IRB/IEC and other applicable regulations/guidelines.
• Demonstrated basic understanding of the clinical trial process.
• Fortrea may consider relevant and equivalent experience in lieu of educational addition to above Candidates without life sciences background but with relevant domain knowledge or experience may be considered if deemed appropriate for specific tasks and activities.
• ICH-GCP guidelines and all other applicable guidelines and regulations.

Experience (Minimum Required):

• Years of experience in the job discipline: 05-08 years of relevant Clinical research experience in pharmaceutical CRO industries or experience in a health care setting
• Other required work-related experiences:

• Demonstrated ability to organize and communicate effectively.
• Demonstrated ability to pay attention to detail.
• Ability to work well with others.
• Ability to deliver consistent high quality of work.
• Ability to use computer and departmental tools.
• An equivalent combination of education and experience to successfully perform key responsibilities.
• Good organizational and time management skills
• Computer literacy (Microsoft Office Suite including Word Excel PowerPoint)

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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