Centralized Study Specialist II

Job Overview:

TheCentralized Study Specialist IIis a pivotal member of a Project Team responsible for the execution of a Clinical Research Project. The degree of responsibility given to theCentralized Study Specialist IIshall reflect their experience and level of contribution which they can make to the project. TheCentralized Study Specialist IIperforms and leads the essential duties as well as stretch goals with minimal guidance and support from the Fortrea web of support including (but not limited to). TheCentralized Study Specialist IIperforms Client and Non-Client specific study-related tasks as required by the department.

When assigned with Startup tasks in maintenance of studies:

Will be primary contact with investigative sites during study maintenance site startup activities with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB/Third body/Regulatory Authority submissions are made within the timelines agreed with project management and Site Readiness team. Develop awareness of regulatory legislation guidance and practice in the assigned countries with the support from senior staff. Prepares and negotiates and assists in the execution and retention of site agreements confidentiality agreements letters of indemnification and other contracts for Sponsors who contract Fortrea to perform this service. Maintains and contributes to contracts tracking and status systems and supports maintenance of paper and electronic file systems. Responsible for following SOPs including but not limited to departmental SOPs as well as completing study-related duties in accordance with the processes set forth in the relevant process document including (but not limited to):

• Works cross-functionally and communicates with project team members regarding study updates Communicate effectively with project team members regarding study updates - This will primarily be Project Management (PM) Start-up (SU) Clinical and Vendor Management (VM) however communication with all study team members is essential.
• Maintain documentation as required by protocols SOPs and regulatory standards to ensure timely production of high-quality clinical data
• Provides cross-functional systems support and tracks information related to the status of study activities. Acts as SME in many systems and processes
• Will be responsible for ensuring quality and integrity of data and additional study-related activities to support the efforts of study team members.
• Takes ownership of higher-level assignments from all functional groups to enhance skill set and leadership attributes
• Activities will be conducted in compliance with Company or Sponsor SOPs and regulatory standards and guidelines applicable.

Principal Contacts and Scope of Communications includes:

• Internal: Clinical operations Site Readiness Project Management and other cross functional teams
• External: Investigative Site Sponsors/Client Vendors (Including but not limited to translation IVRS/IWRS laboratories and Investigative site staff)

Summary of Responsibilities (Study Support Tasks)

• Follow all applicable departmental Standard Operating Procedures and Work Instructions.
• Execute high quality timely monitoring and reporting plan(s) including specialized monitoring requests for approved protocols.
• Support implementation of new monitoring tools
• Track and report metrics as determined by management according to required timelines.
• Proactively identify opportunities for process improvements and participate in implementation.
• Able 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
• Support study teams to resolve data management queries
• 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
• Manage study payments (Site and Vendor) Ex: Payment reconciliation and release
• Review study performance dashboard
• Document and track study activities using relevant forms and tools as well as relevant Project Management Systems with guidance/support.
• 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.
• Maintain Trial Master File documentation within the appropriate TMF platform participate in TMF QC as assigned and track and /archive as applicable.
• Actively support compliance metrics including TMF CTMS and overall project health.
• Update timelines and milestones within project scheduling tools CTMS project governance tool and other trackers which will include updates for all applicable functions. Escalate when timelines are a risk.
• Update Xcellerate Risk Identification & Issue Resolution (XRIM) tool and follow up outstanding action items to resolution including Protocol Deviations.
• Draft or assist Functional Leads with project plans and coordinating review feedback and execution between study team and client.
• May assist with additional cross-functional tasks according to project needs
• 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 (XITE) at study level upon PM approval
• Collaborates with the functional lead to ensure timely resolution of XITE alerts within the system.

When assigned managing amendments within Startup tasks in maintenance phase of studies:

• Develop awareness of regulatory legislation guidance and practice in the assigned countries
• Compile prepare submit and obtain approval of the submission documents to IRB/IEC/Third body/Regulatory Authority (e.g. INDs/CTAs) in accordance with local requirements.
• Liaise with internal and external vendors in the generation of Regulatory Authority
• submissions (as applicable) and perform a review of final submission documents as applicable.
• Organize communication related to the submissions/outcomes within Fortrea as applicable and Escalate study issues appropriately and in a timely fashion and perform other duties as assigned by management depending upon country and situational requirements with proper supervision (if applicable).
• Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.
• Collect and track all the necessary documents required and perform a quality review formatting and compilation of the final documents for effective and compliant site
• maintenance.

Review and customize country and site-specific patient informed consent forms for compliance with local requirements and protocol. Proactively resolved consent issues and other potential difficulties with study sites.

• Ensure that all assigned maintenance start-up activities are on track and in accordance

with client expectations ICH/GCP SOPs budget quality and applicable laws and guidelines.

• Update study documents when there are changes in study personnel/study amendments & ensure high quality documents are filed and systems are updated on an ongoing and timely basis making Fortrea ready for an audit at any time.
• Update status reports applicable logs and tracking systems as applicable for the projects
• With guidance from line manager and experienced colleagues adapt Informed Consent
• Forms and other patients facing material to country specific requirements.
• Support / assist the contract negotiation process & proactively identifying and escalating to Submission Leads any risk to meeting deliverables.
• Clinical Trials Information System (CTIS) tasks (specific centralized role for EU) and Upload of submission documentation to CTIS under supervision as applicable.
• Daily tracking negotiation and approval of Site Agreements and Site Agreement templates (as applicable) for clinical study teams; timely updating of the departmental Site Agreement Management System (SAMS) or any other system required for use on a particular study.
• Identify and escalate issues (as defined in departmental processes) that must be escalated to line manager for review.
• Manage assigned studies with careful compliance with internal processes and procedures or otherwise according to specified Sponsor requirements.

Responsible for the timely updating of the departmental contract tracking system and Performs contract administration functions including assisting with obtaining approvals on authorization forms as required maintaining a contract tracking system to report contract status

• Updates and signing status; providing notice of all executed contracts to the appropriate team members along with contract values; and scanning and filing executed contracts in the shared electronic storage area in a timely manner for access by other staff members.
• Provides management with regular status updates on all open contracts and any outstanding issues.
• Drafts negotiates reviews and processes contracts in a commercially reasonably manner that protects Fortreas fundamental interests and in accordance with departmental practices and policies. Produces and negotiates contracts that accurately reflect Fortreas obligations or rights and understandings with third parties.
• Negotiates contractual terms with other contracting parties in a professional manner and ability to apply knowledge of the principles of ICH GCP to their work and follow quality standard procedures.
• Identifies potential obstacles in the contracting process promptly and requests assistance of line manager project management staff Business Development staff Budgets & Proposals staff or higher management as necessary to minimize delays and to facilitate the prompt conclusion of contractual negotiations.
• Works closely with appropriate staff to keep them informed of progress of agreements and to avoid any delays in execution.
• Provides support to other Site Agreements staff and assists internal staff with contractual inquiries as required. & facilitates the internal review/revision/sign off process on contracts prior to forwarding to external parties.
• Coordinate and communicate with clinical study teams in a timely manner regarding contract details and timelines as well as contract status reporting to ensure quick approval of templates and contracts.
• Assist in development and ongoing improvement of departmental processes and procedures.
• All other duties as needed or assigned
  • Knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs required.
  • Ability to train and supervise junior staff.
  • Ability to Critically Think and Problem Solving
  • Ability to resolve project-related problems and prioritizes workload for self and team.
  • Ability to work with minimal supervision.
  • Demonstrated ability to lead by example and to encourage team members to seek solutions independently.
  • Basic project management skills including planning and organizational skills.
  • Study Financial Acumen
  • Works efficiently and effectively in a matrix environment
  • Ability to negotiate and liaise with clients in a professional manner.
  • Advanced verbal and written communication skills
  • Advanced computer skills (Microsoft Office Suite (Word Excel PowerPoint)
  • Able to deputize for Functional Leads to cover tasks if required on an ad hoc basis.

Additional responsibilities (Centralized study team may perform below activities):

• Facilitate study team communication & collaboration by attending & setting up team meetings for all functions as needed.
• Facilitate and document meetings with relevant tools in internal and external calls and ensure they are distributed and documented in accordance with study requirements

Vendor Management oversight.

• Exhibit Strong Stakeholder Management Skills including negotiation and proactive communication with sponsor sites and project team

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 5 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.
• Previous interaction with operational project teams and investigative sites.
• 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: 06-08 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.
• Strong interpersonal skills with ability to work well with others.
• Ability to deliver consistent high quality of work.
• Strong understanding of clinical trial planning management and metrics and the ability to focus on multiple deliverables is important.

Preferred Qualifications Include:

The Competencies define the behaviors necessary for the organization to achieve business outcomes.

• Focus on Customers /Sponsors
• Focus on Investigative Sites
• Innovate and Change
• Pursue Scientific and Process Excellence
• Work with Others
• Achieve Results
• Eager to take initiative and be proactive.
• Ability to work with a sense of urgency and being results oriented.
• Aptitude for handling and proof-reading numerical data some spreadsheet software competency
• Must be flexible to accept changes in work assignments as business needs require.
• Strategic Thinking and Leadership as a contributor
• Business and Financial Acumen as a contributor
• Creative Problem solving
• May travel occasionally (both domestic and global).
• Fluent in English both written and verbal.
• Scope of position would be all regions in world.

Physical Demands / Work Environment:

• Candidate should be able to work in shifts if business demands for it.
• May involve extensive use of computer and keyboard.
• May need to contact Investigative Sites with Line manager supervision

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